MAUDE Adverse Event Report: VASCUTEK LTD GELWEAVE EXTRA LONG BIFURCATES

Catalog Number	732211XL55-G
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufactures narrative clinical code: 4580 - insufficient information: it was confirmed by site on 28 nov 23 that no further information would be provided.Impact code: 4624 - surgical intervention: need to sew the graft hole with a 5.0 thread to get hemostasis of the graft 4648 - insufficient information: it was confirmed by site on 28 nov 23 that no further information would be provided.Medical device problem: 2588 - defective device: as reported from site loose knit at the graft bifurcation component code: 4755 - part/component/sub-assembly term not applicable type of investigation 4111 - communication/ interview: it was confirmed by site on 28 nov 23 that no further information would be provided.3331 - analysis of production records: full batch review performed and no issues with raw material of finished product identified 4114 - device not returned: device remains implanted.Investigation findings: 3221 - no findings available: due to the site confirming on 28 nov 23 that no further information would be made available.Also device was not returned as remains implanted the investigation could not be completed.Investigation conclusion: 4315 - cause not established: due to the site confirming on 28 nov 23 that no further information would be made available.Also device was not returned as remains implanted.The investigation could not be completed.
Event or Problem Description
Device failure/ deficiency was due to loose knit at the graft bifurcation.Blood leakage at the bifurcation level.Patient outcome: need to sew the graft hole with a 5.0 thread to get hemostasis of the graft.This report is being submitted as a initial / final for mfg.Report to provide event closure information for comp (b)(4).

• Brand Name: GELWEAVE EXTRA LONG BIFURCATES
• Common Device Name: GELWEAVE EXTRA LONG BIFURCATES
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan; glasgow, PA49R R; UK PA49RR
• Manufacturer (Section G): VASCUTEK LTD; newmains avenue; inchinnan; glasgow, PA49R R; UK PA49RR
• Manufacturer Contact: jason whittle ; newmains avenue; inchinnan; glasgow, PA49R-R ; UK PA49RR
• MDR Report Key: 18343321
• Report Number: 9612515-2023-00034
• Device Sequence Number: 8424793
• Product Code: DSY
• UDI-Device Identifier: 05037881107660
• UDI-Public: 05037881107660
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K964665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Catalogue Number: 732211XL55-G
• Device Lot Number: 21966271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown