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

Catalog Number	631809P-G
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	06/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Analysis of production records - a review of qc, manufacturing and physical test records was performed and showed that batch was manufactured to design specification.All released grafts from batch also met acceptance criteria for all physical tests on base material and in process testing.Historical data review - a review of similar events was performed for all gelsoft branded devices where leakage has been reported between jan 14 - jun 19 inclusive.The incident rate for leakage of gelsoft branded devices was confirmed as 0.008% (rate=complaints v sales).A similar review was performed for all polyester vascutek branded devices which provided a rate of (b)(4).No negative trend was identified during the review.Device not accessible for testing - actual device remains implanted, therefore no testing could be performed.No device problem found - review of device batch history records could find no issue with batch that would lead to issue reported during procedure.Cause not established - the review of the retained manufacturing records and historical complaints data identified no issues with the manufacture of the device or any negative trends.As the device was unable to be returned to vascutek ltd.For analysis and no other devices from this batch were available for testing, no root cause was determined for the reported issue.Vascutek ltd.Now considers this complaint closed 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
After the graft was anastomosed (proximal end) two (2) holes were identified (one in the body and one in the right leg).The surgeons decided to keep the graft in place and sutured the holes.

• 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: 8779542
• Report Number: 9612515-2019-00018
• Device Sequence Number: 16669812
• Product Code: DSY
• UDI-Device Identifier: 05037881115535
• UDI-Public: 05037881115535
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 07/11/2019
• Report Date (Section F): 06/13/2019

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: 02/28/2022
• Device Catalogue Number: 631809P-G
• Device Lot Number: 17711917
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/13/2019
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 07/11/2019
• 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