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

Catalog Number	631809DB
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	08/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Bleeding was reported through the graft material.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.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 was confirmed as 0.030% (rate=complaints v sales).No negative trend was identified during the review.Actual device remains implanted, therefore no testing could be performed.Investigation in progress, vascutek ltd.Has requested additional information.Once this information is received, the findings will be communicated within the next report.
Event or Problem Description
During the implantation surgery of a gelsoft double bifurcate that occurred on (b)(6) 2019.The clinician reported that the graft leaked in two locations (bifurcation and the root of a branch).The leakage was arrested by suturing these locations.The procedure was completed without any further complications.
Additional Manufacturer Narrative
Corrected data: section d1 incorrect product brand name provided (gelweave), correct brand name (gelsoft).Section d2 common device name incorrect name provided (gelweave double bifurcate), correct common device name (gelsoft double bifurcate).Section h6: patient code - 2597 - blood loss during procedure.Device code - 2978 - material integrity problem - bleeding was reported through the graft material.Method code - 3331 - 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.Method code - 4109 - 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.(b)(4).No negative trend was identified during the review.Method code - 4117 - device not accessible for testing - actual device remains implanted, therefore no testing could be performed.Result code - 3233 - results pending completion of investigation.Conclusion code - 11 - conclusion not yet available - investigation in progress, vascutek ltd.Has requested additional information.Once this information is received, the findings will be communicated within the next report.
Event or Problem Description
During the implantation surgery of a gelsoft double bifurcate that occurred on (b)(6) 2019.The clinician reported that the graft leaked in two locations (bifurcation and the root of a branch).The leakage was arrested by suturing these locations.The procedure was completed without any further complications.
Additional Manufacturer Narrative
Manufacturers narrative section h6.Patient code - 2597 - blood loss during procedure.Device code - 2978 - material integrity problem - bleeding was reported through the graft material.Method code - 3331 - 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.Method code - 4109 - 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.(b)(4).No negative trend was identified during the review.Method code - 4117 - device not accessible for testing - actual device remains implanted, therefore no testing could be performed.Results code - 213 - no device problem found: review of product batch records showed no issue with the manufacture of this batch.Conclusion code - 19 - caused traced to user - from the information received, users failure to rinse the device for 5 mins prior to the procedure may have contributed to the leakage seen.Vascutek ltd, now considers this complaint closed.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.

• Brand Name: GELSOFT
• Common Device Name: GELSOFT DOUBLE BIFURCATE
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 9102459
• Report Number: 9612515-2019-00025
• Device Sequence Number: 1971925
• Product Code: DSY
• UDI-Device Identifier: 05037881110011
• UDI-Public: 05037881110011
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K964665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2019
• Report Date (Section F): 08/26/2019

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: 04/30/2023
• Device Catalogue Number: 631809DB
• Device Lot Number: 17272462
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 18 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/26/2019
• Initial Date Received by Manufacturer: 08/26/2019
• Supplement Date Received by Manufacturer: 08/26/2019; 08/26/2019
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 09/23/2019; 10/22/2019
• 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