MAUDE Adverse Event Report: VASCUTEK LTD GELWEAVE; GEWEAVE ANTI-FLO

Model Number	GELWEAVE ANTI-FLO
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Leakage was stopped by application of tacka seal and device remains in situ.(b)(4).Method - actual device not evaluated as remains implanted in patient; review of qc and manufacturing records was carried out including review of physical test of base fabric for body and branch.Results - review of the qc and manufacturing records was performed and this batch was found to be manufactured to design specification.Review of physical test results for base fabric showed all test results were within acceptance criteria.Review of porosity test results of gelled graft batch were all within acceptance criteria.Device was not returned therefore no further investigation could be carried out.No issues were found with batch manufacture or physical test results.(b)(4).As no device was returned for physical investigation, no further investigation was possible, the issue will be tracked and trended as part of the routine complaints monitoring and reporting process.If an adverse trend develops action may be taken at that time.Vascutek now considers this complaint closed.Device remains in situ.
Event or Problem Description
Vascutek received a report that blood was leaking through graft.The leak was below the side branch.Tacka seal was applied to stop leak.A video of the leak was provided however this showed only the leaking of the graft.No video was provided of graft preparation or handling prior to leakage event.There was no reported delay to the procedure, significant blood loss or patient effect as a result of the leakage.

• Brand Name: GELWEAVE
• Common Device Name: GEWEAVE ANTI-FLO
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, scotland PA4 9 RR; UK PA4 9RR
• MDR Report Key: 5909803
• Report Number: 9612515-2016-00023
• Device Sequence Number: 13585171
• Product Code: DSY
• UDI-Device Identifier: 05037881105925
• UDI-Public: 05037881105925
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K040829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 08/29/2016
• Report Date (Section F): 08/03/2016

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: Physician
• Device Expiration Date: 01/31/2021
• Device Model Number: GELWEAVE ANTI-FLO
• Device Catalogue Number: 734026/8
• Device Lot Number: 375399
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/01/2016
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/03/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2016
• Initial Report FDA Received Date: 08/29/2016
• 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: Required Intervention