MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION VASCU-GUARD; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Catalog Number	VG0108N
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	10/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
A patient underwent a carotid artery endarterectomy surgery in which vascu-guard patches were used.Following surgery, the patient was transferred to the cardiac care unit (ccu) with no signs of hematoma and a jp drain in place.Approximately five hours later, the patient experienced bleeding and presented with a deviated trachea, no stridor was noted.It was reported 10 minutes later, the patient was transferred to the operating room and was intubated.Following intubation, ¿very large amount of blood clots¿ were evacuated, and after the carotid artery was visible, the doctor noted that a portion of the vascu-guard was ¿frayed¿ or ¿somehow degraded¿.The physician was not able to recover pieces of the graft area.A second vascu-guard patch was put in place to re-enforce the original patch graft site, no issues were noted.The patient remained intubated and transferred back to ccu.Additional treatment or interventions were not reported.At the time of this report, the patient outcome was not reported.No additional information is available.
Additional Manufacturer Narrative
The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: VASCU-GUARD
• Common Device Name: PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11113445
• Report Number: 1416980-2021-00002
• Device Sequence Number: 19813932
• Product Code: DXZ
• UDI-Device Identifier: 00085412530895
• UDI-Public: (01)00085412530895
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K983602
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/02/2025
• Device Catalogue Number: VG0108N
• Device Lot Number: SP20I03-1474350
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 01/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention