MAUDE Adverse Event Report: VASCUTEK LTD GELWEAVE; GELWEAVE VASLALVA ANTEFLO

Model Number	GELWEAVE VALSALVA ANTEFLO
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The clinician was implanting a gelweave valsalva anteflo device and was attempting to fashion a hole in the graft using a cautery.When doing so, the graft briefly caught fire.The clinician replaced the graft with another unit and completed the surgery without further incident.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: GELWEAVE
• Common Device Name: GELWEAVE VASLALVA ANTEFLO
• 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: 12850633
• Report Number: 9612515-2021-00025
• Device Sequence Number: 17145080
• Product Code: DSY
• UDI-Device Identifier: 05037881120300
• UDI-Public: 05037881120300
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K013022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/22/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: GELWEAVE VALSALVA ANTEFLO
• Device Catalogue Number: 734026/10ADP-J
• Device Lot Number: 21779995
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/14/2021
• 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: Other
• Patient Sex: Unknown