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 (b)(4).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 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.
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.
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 9612515-2025-00048 to provide event closure information for tag0219.

• 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: 21991932
• Report Number: 9612515-2025-00048
• Device Sequence Number: 20911072
• 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: 25913672
• 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: 09/20/2024
• 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