MAUDE Adverse Event Report: VASCUTEK LTD. GELWEAVE; GELWEAVE ANTE-FLO

Model Number 735028/8S

Device Problem Material Integrity Problem (2978)

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

Event Date 11/06/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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

On (b)(6) 2020 gelweave ante-flo graft implanted, leakage was noted during operation when clamps were removed, constant bleeding was noted from long ante-flo branch.Graft was pre-soaked as advised in the ifu.Sutures were applied to stop the leak.Procedure was extended by about 5 minutes.Patient recovered.

• Brand Name: GELWEAVE
• Type of Device: GELWEAVE ANTE-FLO
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): VASCUTEK LTD.; 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: 14039486
• MDR Text Key: 298503624
• Report Number: 9612515-2022-00002
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881106731
• UDI-Public: 05037881106731
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K952293
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 735028/8S
• Device Catalogue Number: 735028/8S-G
• Device Lot Number: 17974094
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/17/2019
• 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