MAUDE Adverse Event Report: VASCUTEK LTD GELSOFT PLUS BIFURCATE

Model Number GELSOFT PLUS BIFURCATE

Device Problem Material Integrity Problem (2978)

Patient Problem Blood Loss (2597)

Event Date 03/20/2019

Event Type  malfunction  

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 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
• Type of Device: GELSOFT PLUS BIFURCATE
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: carolyn forrest ; newmains avenue; inchinnan business park; renfrewshire PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 8526321
• MDR Text Key: 145647767
• Report Number: 9612515-2019-00006
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881115528
• UDI-Public: 05037881115528
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K955230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2019,04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• 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
• Date Manufacturer Received: 03/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 50