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

Model Number	GELSOFT PLUS BIFURCATE
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Analysis of production records, a review of qc and manufacturing records was performed with attention to porosity testing results.Review showed batch was manufactured to design specification and all porosity testing fell within acceptance criteria trend analysis.A 5-year review of similar complaints was performed for all gelsoft branded devices provided an incidence rate of (b)(4).No further complaints were received from devices from same batch.Communication/interviews (b)(4).Received further information from site on event relative to how the graft was used/handled and the clinicians opinion on graft performance and handling.Device not accessible for testing.Device remains implanted and was not returned for investigation.No device problem found - no issue was found with the review of batch manufacture or testing prior to release.Cause not established - root cause could not be definitively established from information received or from review scans provided.
Event or Problem Description
On (b)(6) 2020 a clinician implanted a gelsoft plus bifurcate graft.After anastomosis but before the release of blood into the graft, a large hole (undefined size) was identified at the bifurcation.The device was discarded and a replacement unit was utilised and the procedure was completed without further issue.

• Brand Name: GLESOFT PLUS
• Common Device Name: GLESOFT PLUS BIFURCATE
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 10910660
• Report Number: 9612515-2020-00018
• Device Sequence Number: 3315494
• Product Code: DSY
• UDI-Device Identifier: 05037881115528
• UDI-Public: 05037881115528
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K955230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/26/2020

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: 01/31/2023
• Device Model Number: GELSOFT PLUS BIFURCATE
• Device Catalogue Number: 631608P
• Device Lot Number: 18152518
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 11/26/2020
• 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: 69 YR