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

Catalog Number	636008P
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	07/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A review of similar events was performed for all gelsoft branded devices that have been reported to have leaked and that were impregnated with russelot or gelita gelatin.The incident rate for reported leakage events was confirmed as (b)(4) for products impregnated with both gelatin types.This is the first compliant for leakage for the grafts impregnated with gelita gelatin (occurrence rate of (b)(4) complaints v sales).The review included all similar events reported to vascutek between jan2013 - jul2018 inclusive.No negative trend was identified during the review.Vascutek awaiting further information from site.
Event or Problem Description
Vascutek ltd.Was notified of an event that occurred in (b)(6), the event was described as follows: during femoro-popliteal bypass surgery, the prosthesis gelsoft plus presented many defects once it was in load (after completion of a proximal anastomosis).Many small holes have been seen all along the graft, inducing massive blood loss greater than 900cc for the patient, filling made with 1250cc of crystalloid and 2 pellets of gr for transfusion.Patient is doing well.There was no post-operative leakage observed.
Additional Manufacturer Narrative
Cause not established.The root cause of the event could not be identified as device was not available for further analysis and additional information was not received from the customer.Three attempts were made to obtain additional information about the event.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.(b)(4) consider this case closed.
Event or Problem Description
This report is being submitted as follow up # 1 for mfr.Report # 9612515-2018-00012 to provide closure information for the case.

• Brand Name: GELSOFT PLUS
• Common Device Name: GELSOFT PLUS STRAIGHT
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 7812309
• Report Number: 9612515-2018-00012
• Device Sequence Number: 11192554
• Product Code: DSY
• UDI-Device Identifier: 05037881115047
• UDI-Public: 05037881115047
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K955230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Repair,Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2018
• Report Date (Section F): 07/27/2018

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: 03/31/2021
• Device Catalogue Number: 636008P
• Device Lot Number: 17294589-1088
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/20/2018
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/27/2018
• Initial Date Received by Manufacturer: 07/27/2018
• Supplement Date Received by Manufacturer: 07/27/2018
• Initial Report FDA Received Date: 08/24/2018
• Supplement Report FDA Received Date: 10/05/2018
• 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: Life Threatening; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 80