MAUDE Adverse Event Report: VASCUTEK LTD GELSOFT PLUS BIFURCATE

Model Number	GELSOFT PLUS BIFURCATE
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	03/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturers narrative: (b)(4).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 - mar 19 inclusive.The incident rate for general leakage was confirmed as (b)(4) rate=complaints v sales).No negative trend was identified during the review.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
Vascutek ltd received a notification from our (b)(4) distributor, who reported that during the implant of a gelsoft plus bifurcate vascular graft, leakage was reported from the proximal end of the left limb of the device.The leakage was arrested using localised manual pressure and the application of tacoseal to the affected site.The procedure was elective and was deemed as successful with no additional surgical time required.

• Brand Name: GELSOFT PLUS BIFURCATE
• 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: 8526321
• Report Number: 9612515-2019-00006
• Device Sequence Number: 1928734
• Product Code: DSY
• UDI-Device Identifier: 05037881115528
• UDI-Public: 05037881115528
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K955230
• 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): 04/17/2019
• Report Date (Section F): 03/20/2019

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: 03/31/2021
• Device Model Number: GELSOFT PLUS BIFURCATE
• Device Catalogue Number: 631608P-G
• Device Lot Number: 17107257
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/20/2019
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 04/18/2019
• 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
• Patient Age: 58 YR
• Patient Weight: 50