MAUDE Adverse Event Report: VASCUTEK LTD. GELWEAVE; GELWEAVE STRAIGHT

Model Number	GELWEAVE STRAIGHT
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During procedure on (b)(6) 2022, 10mm gelweave graft that was used for axilliary cannulation was leaking.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Manufacturer narrative: investigation findings: 213 - no device problem found - the section of returned sample was porosity tested which gave a result of 181ml/min.Specification states max limit is 515ml/min., a sem analysis was performed on the 28 nov 22, this showed the weave of the fabric was uniform and had no abnormality in the structure of the fabric which could have caused the reported leakage., a textile review was performed on the sample which confirmed the graft size and that the weave was tight showing no defects.Investigation conclusion : 67 - no problem detected - review of manufacturing records showed the device was manufactured to specification,, analysis of returned section of graft gave results within specified parameters therefore no problem was confirmed.4315 - cause not established - the root cause of the event could not be determined.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
This report is being submitted as follow up # 1 for mfg.Report 9612515-2022-00019, (b)(4) to provide event closure information.

• Brand Name: GELWEAVE
• Common Device Name: GELWEAVE STRAIGHT
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan bsiness park; glasgow, renfrewshire PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): VASCUTEK LTD.; newmains avenue; inchinnan business park; glasgow, renfrewshire PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: jason whittle ; newmains avenue; inchinnan business park; glasgow, renfrewshire PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 15734278
• Report Number: 9612515-2022-00019
• Device Sequence Number: 16883787
• Product Code: DSY
• UDI-Device Identifier: 05037881105147
• UDI-Public: 05037881105147
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K952293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2023

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: 08/31/2024
• Device Model Number: GELWEAVE STRAIGHT
• Device Catalogue Number: 733010-G
• Device Lot Number: 21974136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2022
• Supplement Date Received by Manufacturer: 10/10/2022
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2021
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown