- Email: [email protected]
Complications related to the use of vascular hemostasis devices
FROM THE FOOD AND DRUG ADMINISTRATION
Complications Related to the Use of Vascular Hemostasis Devices Beverly Albrecht-Gallauresi, RN, BS, MPH
he Food and Drug Administration (FDA) receives reports of adverse events involving medical devices that may have caused or contributed to a death or serious injury. Since 1996, the FDA has received more than 1400 serious injury and 26 death reports involving the use of vascular hemostasis devices (Table). Hemostasis devices are used percutaneously to seal off the femoral artery puncture site that is accessed during diagnostic and interventional cardiac catheterization. Three types of hemostasis devices that are currently marketed have been approved by the FDA: (1) a collagen plug placed at the femoral artery puncture site; (2) an extravascular collagen plug in combination with a biodegradable anchor placed inside the femoral artery; and (3) devices that use surgical sutures deployed around the arterial entry site. A major problem reported to the FDA is bleeding from the femoral artery resulting in hematoma, exsanguination, and subsequent patient death. The FDA has received adverse event reports involving such injury from each of these device types. Potential contributing factors for bleeding include patient selection, user training, and improper insertion technique.
T
Beverly Albrecht-Gallauresi, RN, BS, MPH, is a nurse consultant in the Division of Postmarket Surveillance, Center for Devices and Radiological Health, Food and Drug Administration. The opinions and statements contained in this report are those of the author and may not reflect the views of the Department of Health and Human Services. Please write [email protected] with comments. Reprints not available from author. Int J Trauma Nurs 2000;6:64-5. 65/1/106602 doi:10.1067/mtn.2000.106602 64 INTERNATIONAL JOURNAL OF TRAUMA NURSING/FDA
The following 2 case studies are excerpted from reports received by the FDA. CASE REPORT 1 A 69-year-old man underwent a diagnostic cardiac catheterization. After the procedure a hemostasis device was used at the femoral artery site to prevent bleeding. When continued oozing was observed at the insertion site, the physician assessed the patient and diagnosed retroperitoneal bleeding. A large hematoma caused obstruction and subsequent kidney damage. The patient subsequently underwent hemodialysis.1 CASE REPORT 2 A 39-year-old man underwent a diagnostic cardiac catheterization. During the procedure the cardiologist used multiple needle sticks to locate the femoral artery. It is believed that the back wall of the femoral artery was punctured. The patient became very restless during the procedure and additional sedation was needed to continue. After the procedure, a hemostasis device was used to control bleeding at the femoral puncture site. Continuous oozing was noted from the site, and the patient remained restless; within 15 minutes his blood pressure dropped significantly. Medications and medical interventions did not improve the patient’s condition. He continued to deteriorate, experienced cardiac arrest, and died. The patient’s cause of death was exsanguination as a result of retroperitoneal bleeding. The FDA convened a committee to evaluate the etiology of the reported complications associated with the use of these devices. Their deliberations, in an effort to reduce the number of complications related to hemostasis devices, led the FDA to issue the following recommendations in an FDA “Dear Colleague Letter” to health care practitioners: Manufacturers’ instructions and recommendations vary for individual vascular hemostasis devices. In general, VOLUME 6, NUMBER 2
to avoid complications when using vascular hemostasis devices, we recommend that you carefully follow the device manufacturers’ warnings, precautions, and instructions regarding patient selection and device use.
Whenever treatment modalities, such as vascular hemostasis devices, are used, there is still a need for careful nursing observation. In addition, we offer the following specific recommendations: • Do not use vascular hemostasis devices to treat patients with suspected double wall punctures, as punctures of the posterior wall are not closed with these devices. • Carefully weigh the risk of bleeding at the puncture site against the benefits of using a vascular hemostasis device when treating patients with bleeding disorders or patients medicated with platelet glycoprotein IIb/IIIa receptor inhibitors. • Carefully monitor the groin puncture site to minimize the occurrence of complications with vascular hemostasis devices. • Special attention should be paid to any post-procedure patient-management instructions or ambulation recommendations for the specific vascular hemostasis device used.2
IMPLICATIONS FOR TRAUMA NURSING Case reports 1 and 2 are related to iatrogenic trauma; however, the significance of using such devices should not be overlooked for other types of trauma. Whenever treatment modalities, such as vascular hemostasis devices, are used, there is still a need for careful nursing observation to determine
APRIL-JUNE 2000
Table. Adverse events reported to the FDA regarding hemostasis devices, 1996-1999 Type of event Death Injury Malfunction Other Total
Number of reports 26 1454 353 73 1906
if the device is effective. Nurses should observe the patient for trends in vital sign changes, signs and symptoms of blood loss, the presence of a hematoma or ecchymosis, or the loss of arterial perfusion distal to the puncture site. REPORTING ADVERSE EVENTS The FDA is interested in additional data on adverse events involving the use of hemostasis devices or other medical and radiation-emitting devices. Health care providers employed by facilities (eg, hospitals, nursing homes) that are subject to FDA’s user facility reporting requirements should follow the reporting procedures established by their facility. All other providers may submit their reports to MedWatch, FDA’s voluntary reporting program. The reports can be submitted by telephone at 1-800-FDA-1088; fax: 1-800-FDA-0178; via the MedWatch Web site at http://www.fda.gov/medwatch; or by mail to MedWatch, FDA, HF-2, 5600 Fishers Ln, Rockville, Maryland 20852-9787. REFERENCES 1. Gallauresi BA. Collagen hemostasis devices. Nursing 1999 Jan;29:31. 2. Feigal DW. FDA Dear colleague letter: complications related to the use of vascular hemostasis devices. Rockville (MD): US Department of Health and Human Services; 1999.
INTERNATIONAL JOURNAL OF TRAUMA NURSING/FDA 65
Complications Related to the Use of Vascular Hemostasis Devices Beverly Albrecht-Gallauresi, RN, BS, MPH
he Food and Drug Administration (FDA) receives reports of adverse events involving medical devices that may have caused or contributed to a death or serious injury. Since 1996, the FDA has received more than 1400 serious injury and 26 death reports involving the use of vascular hemostasis devices (Table). Hemostasis devices are used percutaneously to seal off the femoral artery puncture site that is accessed during diagnostic and interventional cardiac catheterization. Three types of hemostasis devices that are currently marketed have been approved by the FDA: (1) a collagen plug placed at the femoral artery puncture site; (2) an extravascular collagen plug in combination with a biodegradable anchor placed inside the femoral artery; and (3) devices that use surgical sutures deployed around the arterial entry site. A major problem reported to the FDA is bleeding from the femoral artery resulting in hematoma, exsanguination, and subsequent patient death. The FDA has received adverse event reports involving such injury from each of these device types. Potential contributing factors for bleeding include patient selection, user training, and improper insertion technique.
T
Beverly Albrecht-Gallauresi, RN, BS, MPH, is a nurse consultant in the Division of Postmarket Surveillance, Center for Devices and Radiological Health, Food and Drug Administration. The opinions and statements contained in this report are those of the author and may not reflect the views of the Department of Health and Human Services. Please write [email protected] with comments. Reprints not available from author. Int J Trauma Nurs 2000;6:64-5. 65/1/106602 doi:10.1067/mtn.2000.106602 64 INTERNATIONAL JOURNAL OF TRAUMA NURSING/FDA
The following 2 case studies are excerpted from reports received by the FDA. CASE REPORT 1 A 69-year-old man underwent a diagnostic cardiac catheterization. After the procedure a hemostasis device was used at the femoral artery site to prevent bleeding. When continued oozing was observed at the insertion site, the physician assessed the patient and diagnosed retroperitoneal bleeding. A large hematoma caused obstruction and subsequent kidney damage. The patient subsequently underwent hemodialysis.1 CASE REPORT 2 A 39-year-old man underwent a diagnostic cardiac catheterization. During the procedure the cardiologist used multiple needle sticks to locate the femoral artery. It is believed that the back wall of the femoral artery was punctured. The patient became very restless during the procedure and additional sedation was needed to continue. After the procedure, a hemostasis device was used to control bleeding at the femoral puncture site. Continuous oozing was noted from the site, and the patient remained restless; within 15 minutes his blood pressure dropped significantly. Medications and medical interventions did not improve the patient’s condition. He continued to deteriorate, experienced cardiac arrest, and died. The patient’s cause of death was exsanguination as a result of retroperitoneal bleeding. The FDA convened a committee to evaluate the etiology of the reported complications associated with the use of these devices. Their deliberations, in an effort to reduce the number of complications related to hemostasis devices, led the FDA to issue the following recommendations in an FDA “Dear Colleague Letter” to health care practitioners: Manufacturers’ instructions and recommendations vary for individual vascular hemostasis devices. In general, VOLUME 6, NUMBER 2
to avoid complications when using vascular hemostasis devices, we recommend that you carefully follow the device manufacturers’ warnings, precautions, and instructions regarding patient selection and device use.
Whenever treatment modalities, such as vascular hemostasis devices, are used, there is still a need for careful nursing observation. In addition, we offer the following specific recommendations: • Do not use vascular hemostasis devices to treat patients with suspected double wall punctures, as punctures of the posterior wall are not closed with these devices. • Carefully weigh the risk of bleeding at the puncture site against the benefits of using a vascular hemostasis device when treating patients with bleeding disorders or patients medicated with platelet glycoprotein IIb/IIIa receptor inhibitors. • Carefully monitor the groin puncture site to minimize the occurrence of complications with vascular hemostasis devices. • Special attention should be paid to any post-procedure patient-management instructions or ambulation recommendations for the specific vascular hemostasis device used.2
IMPLICATIONS FOR TRAUMA NURSING Case reports 1 and 2 are related to iatrogenic trauma; however, the significance of using such devices should not be overlooked for other types of trauma. Whenever treatment modalities, such as vascular hemostasis devices, are used, there is still a need for careful nursing observation to determine
APRIL-JUNE 2000
Table. Adverse events reported to the FDA regarding hemostasis devices, 1996-1999 Type of event Death Injury Malfunction Other Total
Number of reports 26 1454 353 73 1906
if the device is effective. Nurses should observe the patient for trends in vital sign changes, signs and symptoms of blood loss, the presence of a hematoma or ecchymosis, or the loss of arterial perfusion distal to the puncture site. REPORTING ADVERSE EVENTS The FDA is interested in additional data on adverse events involving the use of hemostasis devices or other medical and radiation-emitting devices. Health care providers employed by facilities (eg, hospitals, nursing homes) that are subject to FDA’s user facility reporting requirements should follow the reporting procedures established by their facility. All other providers may submit their reports to MedWatch, FDA’s voluntary reporting program. The reports can be submitted by telephone at 1-800-FDA-1088; fax: 1-800-FDA-0178; via the MedWatch Web site at http://www.fda.gov/medwatch; or by mail to MedWatch, FDA, HF-2, 5600 Fishers Ln, Rockville, Maryland 20852-9787. REFERENCES 1. Gallauresi BA. Collagen hemostasis devices. Nursing 1999 Jan;29:31. 2. Feigal DW. FDA Dear colleague letter: complications related to the use of vascular hemostasis devices. Rockville (MD): US Department of Health and Human Services; 1999.
INTERNATIONAL JOURNAL OF TRAUMA NURSING/FDA 65