MAUDE Adverse Event Report: VASCUTEK LTD GELSOFT PLUS; GELSOFT PLUS BIFURCATE

Catalog Number	631407P
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A 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 four passed porosity testing well below acceptance limit of 67ml/min with minimum reading of 04ml/min and highest reading of 08ml/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 (b)(4) (complaints v sales).The review included all similar events reported to vascutek between jan 2014 - jan 2019 inclusive.No negative trend was identified during the review.Customer is returning part of the graft for further analysis.Investigation results will be communicated in follow up / final report.
Event or Problem Description
Vascutek ltd.Was notified of an event that occurred in (b)(6), the event was described as follows: when performing an anastomosis, a 1mm pin hole was found around 1cm from the graft bifurcation.Physician stitched up the pin hole with one stitch and confirmed that no leakage occurred when blood flow was restored.The procedure was successfully completed.
Additional Manufacturer Narrative
Result code: 213 - no device problem found - returned device analysis did not identify any issues with the graft structure.Conclusion code: 4315 - cause not established - root cause of the event could not be established.Only part of the device was returned the rest of the graft is still implanted.Part of graft was returned for further analysis to vascutek ltd.Returned part was measured to 40mm, that is not substantial size to perform leak test; however, burst test was carried out to check the strength of material.The results were within specification.Acceptance criteria for body and seam parts of the graft are minimum of 213n - body and 214n - seam.Results for the returned part of the graft were 326n - body and 286n - seam.There were no issues found with graft material during further analysis.Vascutek ltd could not identify the root cause of the event reported.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.Vascutek ltd considers this complaint closed.
Event or Problem Description
This report is being submitted as final narrative for mfr.Report # (b)(4) to provide closure information for the case.

• Brand Name: GELSOFT PLUS
• Common Device Name: GELSOFT PLUS BIFURCATE
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 8315755
• Report Number: 9612515-2019-00002
• Device Sequence Number: 154488
• Product Code: DSY
• UDI-Device Identifier: 05037881115511
• UDI-Public: 05037881115511
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2019
• Report Date (Section F): 01/16/2019

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: 05/31/2023
• Device Catalogue Number: 631407P
• Device Lot Number: 17347066 1147
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/11/2019
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/16/2019
• Initial Date Received by Manufacturer: 01/16/2019
• Supplement Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 02/07/2019
• Supplement Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention