MAUDE Adverse Event Report: VASCUTEK LTD GELSOFT; GELSOFT CARDIOVASCULAR PATCH

Model Number	960701
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).As no patch will be returned for further investigation as it remains implanted vascutek ltd now considers this complaint closed.Further action is not planned, however, the issue will be tracked and trended as part of the on-going complaints trending and reporting process and if an adverse trend develops action may be taken at that time.
Event or Problem Description
Event was reported from panther study as bleeding / blood loss - bleeding in the recovery ward - compression was applied and no lmwh (low molecular weight heparin) administered post operatively on day 1.The site also indicated that there was some mild patch leakage, at the anastomotic site which they managed with protamin administration and manual compression.It was also indicated that there was some suture hole bleeding - patient under dual antiplatelet and after endarterectomy groin.

• Brand Name: GELSOFT
• Common Device Name: GELSOFT CARDIOVASCULAR PATCH
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): VASCUTEKLTD; newmains avenue; inchinnan business park; renfrewshire PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: jason whittle ; newmains avenue; inchinnan business park; renfrewshire PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 12874576
• Report Number: 9612515-2021-00026
• Device Sequence Number: 4780487
• Product Code: DXZ
• UDI-Device Identifier: 05037881010656
• UDI-Public: 05037881010656
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K200955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 960701
• Device Catalogue Number: 960701-G
• Device Lot Number: 18061972
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 11/25/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown