MAUDE Adverse Event Report: VASCUTEK LTD GELWEAVE STRAIGHT

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Fever (1858)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical code: 1858 - fever: the event was reported by the site the patient had a fever after procedure.Impact code: 4648 - insufficient information: awaiting further information from site.Medical device problem code: 3190 - insufficient information: awaiting further information from site.Component code: 4755 - part/component/sub-assembly term not applicable.Type of investigation: 3331 - analysis of production record: comprehensive batch review still to be performed.4110 - trend analysis: 4- year review was performed for gelweave > medical event > fever which gave an occurrence rate of 0.001%.No trends were identified requiring action at this time.4111 - communication/ interview: awaiting further information from site.4117 - device not accessible for testing: device remains implanted.Investigation findings: 3233 - results pending completion of investigation.Investigation conclusion: 11 - conclusion not yet available.
Event or Problem Description
Event was reported on 10 apr 2025.The event was reported after clinician performed a review of previous cases.Following day 1-2 of implantation, the patient with the implanted device was reported with a fever to 101.8 or higher and leucocytosis to 20's.No negative patient outcome other than the symptoms described were reported.
Event or Problem Description
Event was reported on 10 apr 2025.The event was reported after clinician performed a review of previous cases.Following day 1-2 of implantation, the patient with the implanted device was reported with a fever to 101.8 or higher and leucocytosis to 20's.No negative patient outcome other than the symptoms described were reported.This report is being submitted as follow up #1 for manufacturing report number 9612515-2025-00046 to provide event closure information for tag0217.
Additional Manufacturer Narrative
Clinical code: 1858 - fever: the event was reported by the site the patient had a fever after procedure.Impact code: 4648 - insufficient information: no further information was provided by the site despite several requests for information.Medical device problem code: 3190 - insufficient information: no further information was provided by the site despite several requests for information.Component code: 4755 - part/component/sub-assembly term not applicable.Type of investigation: 3331 - analysis of production record: a comprehensive batch review from raw material to finished product was performed for this device, and no issues during the manufacture of the device was found.4110 - trend analysis: 4- year review was performed for gelweave > medical event > fever which gave an occurrence rate of (b)(4).No trends were identified requiring action at this time.4111 - communication/ interview: no further information was provided by the site despite several requests for information.4117 - device not accessible for testing: device remains implanted.Investigation findings: 3221 - no findings available: no further information was provided by the complainant on this event, despite several attempts to retrieve more information.As no further information was provided, a full investigation was not possible and no root cause was determined.Investigation conclusion: 4315 - cause not established: no further information was provided by the complainant on these events, despite several attempts to retrieve more information.As no further information was provided, a full investigation was not possible and no root cause was determined.

• Brand Name: GELWEAVE STRAIGHT
• Common Device Name: GELWEAVE
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan buiness park; renfrewshire, glasgow PA49R R; UK PA49RR
• Manufacturer (Section G): VASCUTEK LTD; newmains avenue; inchinnan buiness park; renfrewshire, glasgow PA49R R; UK PA49RR
• Manufacturer Contact: laura allan ; newmains avenue; inchinnan buiness park; renfrewshire, glasgow PA49R-R ; UK PA49RR
• MDR Report Key: 21991894
• Report Number: 9612515-2025-00046
• Device Sequence Number: 8479982
• Product Code: DSY
• UDI-Device Identifier: 05037881105734
• UDI-Public: 05037881105734
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K952293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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 Model Number: N/A
• Device Catalogue Number: 732032
• Device Lot Number: 25919021
• 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: 04/10/2025
• Supplement Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2024
• 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: Unknown