MAUDE Adverse Event Report: VASCUTEK LTD GELSOFT PLUS; GELSOFT PLUS ERS AX BIFEM

Catalog Number	690808P
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Review of the retained manufacturing and quality records (with specific emphasis of the base material permeability and device porosity testing) confirmed that the product was manufactured to the intended specifications.The whole batch of 3 passed porosity testing well below acceptance limit of 132ml/min with minimum reading of 25ml/min and highest reading of 30ml/min.A review of similar events was performed for all knitted devices that have been reported to have leaked.The incident rate for reported leakage events was confirmed as 0.021% (complaints v sales).The review included all similar events reported to (b)(4) between (b)(6) 2013 - (b)(6) 2018 inclusive.No negative trend was identified during the review.The distributor informed (b)(4) that the device would not be made available for further investigation, therefore no analysis of the device is possible.As further device analysis is not possible, and graft met all acceptance criteria during testing, (b)(4) consider this event closed.
Event or Problem Description
The event was reported as follows: the graft was leaking severely when checked before implantation.After tunnelling the graft under the skin, washing of the graft with saline was performed, in order to verify its position.An immediate and severe leak was observed at the bifurcation point.The graft was taken out and gore graft was used instead.

• Brand Name: GELSOFT PLUS
• Common Device Name: GELSOFT PLUS ERS AX BIFEM
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 8137918
• Report Number: 9612515-2018-00023
• Device Sequence Number: 13518659
• Product Code: DSY
• UDI-Device Identifier: 05037881115757
• UDI-Public: 05037881115757
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K034010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/06/2018
• Report Date (Section F): 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 690808P
• Device Lot Number: 15958879-9713
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/12/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2018
• Initial Report FDA Received Date: 12/06/2018
• 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
• Patient Age: 79 YR
• Patient Weight: 80