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

Model Number GELSOFT PLUS BIFURCATE

Device Problem Stretched (1601)

Patient Problem Insufficient Information (4580)

Event Date 03/15/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Trend analysis - no negative trend was identified.Communication/interviews - further information on event and its circumstances has been requested from the reporting site as well as clarification of the event/ device relationship.As yet no new information has been provided.Device not accessible for testing - the status of the device is currently unknown.Analysis if production records - qc, manufacturing and physical test records of the base material were retrieved and reviewed and show that the batch was manufactured to design specification and all tests met acceptance criteria.No device problem found - no issue has been found upon review of the retained device history records for this device/batch.Cause not established - limited information was provided and the graft has been discarded by the site, so no pbysical evaluation will be possible.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.

Event Description

A gelsoft plus bifurcate was implanted on (b)(6) 2022.On (b)(6) 2022, the patient underwent a procedure relating to a wound infection.During the cta it was detected that the graft appeared close to the skin.During the intervention the graft was explanted as it appeared to be approx 3cm longer than was anticipated and was close to the skin.

• Brand Name: GELSOFT PLUS
• Type of Device: GELSOFT PLUS BIFURCATE
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan; glasgow, renrewshire PA49R R; UK PA49RR
• Manufacturer (Section G): VASCUTEK LTD; newmains avenue; inchinnan; glasgow, renrewshire PA49R R; UK PA49RR
• Manufacturer Contact: jason whittle ; newmains avenue; inchinnan; glasgow, renrewshire PA49R-R ; UK PA49RR
• MDR Report Key: 14601344
• MDR Text Key: 301990858
• Report Number: 9612515-2022-00005
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881115511
• UDI-Public: 05037881115511
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K955230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: GELSOFT PLUS BIFURCATE
• Device Catalogue Number: 631407P-G
• Device Lot Number: 21580230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2020
• 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: 67 YR
• Patient Sex: Female