MAUDE Adverse Event Report: VASCUTEK LTD GELWEAVE¿; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number	735028/8S
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
We opened the gelweave gelatin woven vascular prosthesis.Per dr.[redacted] it was falling apart; she decided to not use the graft.

• Brand Name: GELWEAVE¿
• Common Device Name: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): VASCUTEK LTD; 799 international parkway; sunrise FL 33325
• MDR Report Key: 25825120
• Report Number: 25825120
• Device Sequence Number: 18576895
• Product Code: DSY
• UDI-Device Identifier: 05037881106731
• UDI-Public: (01)05037881106731
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/14/2026
• Report Date (Section F): 07/14/2026

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 Model Number: 735028/8S
• Device Catalogue Number: 735028/8S
• Device Lot Number: 26051362-7587
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/15/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/15/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Sex: Unknown
• Patient Weight: 78 KG
• Date Report Sent to FDA: 07/14/2026