MAUDE Adverse Event Report: VASCUTEK LTD GELWEAVE; GELWEAVE STRAIGHT

Model Number	GELWEAVE STRAIGHT
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The site advised that the device is not available; therfore no evaluation of the graft was possible.(b)(4).Trend analysis - review of similar complaints of leakage for all gelweave branded devices gave an occurrence rate of (b)(4).Communication/interviews - information has ben requested from the clinician regarding the procedure.Analysis of production records - a review of the retained qc and manufacturing records for this batch (with attention to all in process and base material porosity testing) confirmed that the batch was manufactured to its design specification.Device not returned - the site advised that the device is not available.No device problem found - no issue was found with the manufacturing of the batch (based on the review of the retained production records) the root cause of the reported defect could not be determined.Vascutek ltd.Considers this event as 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, if an adverse trend develops action may be taken at that time.
Event or Problem Description
On (b)(6) 2021, the surgeon utilised a gelweave straight graft for axillary cannulation into a patient.Approximately 90mins into the procedure the gelweave branded graft started to leak (blood was leaking on to the floor).The graft was wiped, but it continued to leak.The graft was under pressure (at an unknown level) and the patients temperature was at 34 degrees.No intervention was performed by the clinical team during use and no negative effect has been reported with regards to the patients condition.

• Brand Name: GELWEAVE
• Common Device Name: GELWEAVE STRAIGHT
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 11392043
• Report Number: 9612515-2021-00008
• Device Sequence Number: 3384009
• Product Code: DSY
• UDI-Device Identifier: 05037881105130
• UDI-Public: 05037881105130
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K952293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/01/2021

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: 07/31/2023
• Device Model Number: GELWEAVE STRAIGHT
• Device Catalogue Number: 733008-G
• Device Lot Number: 21448292
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 03/01/2021
• 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: Other
• Patient Age: 54 YR