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

Model Number 960701

Device Problems Material Puncture/Hole (1504); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/30/2021

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 285943722
• Report Number: 9612515-2021-00026
• Device Sequence Number: 1
• Product Code: DXZ
• UDI-Device Identifier: 05037881010656
• UDI-Public: 05037881010656
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K200955
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/28/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/11/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention