MAUDE Adverse Event Report: Vascutek Ltd. Gelweave; Gelweave Straight

Catalog Number	733010E-B
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
-customer reported that during preparation of a 10x30mm straight graft, white particulate/flaking material was observed coming from the inside of the graft.The customer described the material as white flakes that were thicker than a powder.When the graft was manipulated or "wiggled," the material continued to flake off and was visible on the clinician's glove.Due to the amount of particulate observed, the first graft was passed off the field and is being returned for analysis.( reported under manufacturing report number: 9612515-2026-00062).-a second 10x30mm graft form the same lot was opened.The customer reported that the second graft demonstrated similar white flaking, although to a much lesser extent than the first graft this was implanted successfully with no issues.( this is being reported under manufacturing number 9612515-2026-00063).
Additional Manufacturer Narrative
Manufacturer narrative: clinical code: e 4582 - no clinical signs, symptoms or conditions - device implanted , outcome of procedure was good.Impact code: f 2199- no health consequences or impact - this second device was noted to have white particulate/flaking material however to a lesser extent then the original ( reported under report number: 9612515-2026-00062) this graft was implanted successfully outcome of procedure was good.Device problem code: a 1261 - material fragmentation- white particulate/flaking material was observed coming from the graft.The customer described the material as white flakes that were thicker than a powder.Component code: g 4755 - part/component/sub-assembly term not applicable.Type of investigation: b 4109 - historical data analysis: - gelweave sales jan 22 - aug 26 vs gelweave gelatin detached / flaking events jan 22 - sep 26 gave an occurrence rate of (b)(4) no trend requiring action has been identified.4112 - analysis of information provided by user/third party: additional information has been requested to aid this investigation.3331 - analysis of production records: full batch review performed from base fabric to finished product for device id- 26370041 which confirmed the batch was manufactured to specification.4117 - device not accessible for testing - device remains implanted.Investigation findings: c 3233 - results pending completion of investigation.Investigation conclusion: d 11 - conclusion not yet available as investigation is ongoing.

• Brand Name: Gelweave
• Common Device Name: Gelweave Straight
• Manufacturer (Section D): Vascutek Ltd.; newmains avenue; inchinnan buisness park; glasgow, renfrewshire PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): Vascutek Ltd.; newmains avenue; inchinnan buisness park; glasgow, renfrewshire PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: laura allan ; newmains avenue; inchinnan buisness park; glasgow, renfrewshire PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 50928024
• Report Number: 9612515-2026-00063
• Device Sequence Number: 18831204
• Product Code: DSY
• UDI-Device Identifier: 05037881168678
• UDI-Public: 05037881168678
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K952293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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 Catalogue Number: 733010E-B
• Device Lot Number: 26370041
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2025
• 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: Other
• Patient Sex: Male