MAUDE Adverse Event Report: VASCUTEK LTD. GELSOFT PLUS; GELSOFT PLUS BIFURCATE

Model Number	N/A
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Health effect clinical code (annex e).4582- no clinical signs, symptoms, or conditions.- no health damage to the patient has been reported.Health effect impact code (annex f).2199- no health consequences or impact- no health damage to the patient has been reported.Medical device problem code (annex a).1504- material puncture/hole- 3 holes were determined to be in the graft which were then repaired during surgery.Component code (annex g).4755- part/component/sub-assembly term not applicable.Type of investigation (annex b).4110- trend analysis- a similar event review was performed for leakage > hole / pinhole events in gelsoft plus grafts between jan 20 and oct 24.A similar event rate of 0.010% was confirmed.An increasing trend in gelsoft plus leakage complaints was noted, which is being investigated through internal actions.3331- analysis of production records- a full batch review from raw materials to finished products shall be completed.4112- analysis of data provided by user/third party- vascutek ltd.Has requested additional information relating to the events and their circumstances.Once this information has been received/assessed, the findings will be incorporated within the next available report.4117- device not accessible for testing - device remains implanted.Investigation findings (annex c).3233- results pending completion of investigation.Investigation conclusion (annex d).11- conclusion not yet available.
Event or Problem Description
During surgery on (b)(6) 2024, the surgeon unclamped the right iliac after completing anastamosis and stated that the graft had 3 holes in it.The surgeon repaired all 3 holes and used the product.No patient injury and no surgical intervention as reported by the surgeon.
Event or Problem Description
During surgery on (b)(6) 2024, the surgeon unclamped the right iliac after completing anastamosis and stated that the graft had 3 holes in it.The surgeon repaired all 3 holes and used the product.No patient injury and no surgical intervention as reported by the surgeon.This report is being submited as a final for mfg report number to provide event closure information for tag0064.
Additional Manufacturer Narrative
Health effect clinical code (annex e) 4582- no clinical signs, symptoms, or conditions.- no health damage to the patient has been reported.Health effect impact code (annex f) 2199- no health consequences or impact- no health damage to the patient has been reported.Medical device problem code (annex a) 1504- material puncture/hole- 3 holes were determined to be in the graft which were then repaired during surgery component code (annex g) 4755- part/component/sub-assembly term not applicable type of investigation (annex b) 4110- trend analysis- a similar event review was performed for leakage > hole / pinhole events in gelsoft plus grafts between jan 20 and oct 24.A similar event rate of 0.010% was confirmed.An increasing trend in gelsoft plus leakage complaints was noted, which is being investigated through internal actions.3331- analysis of production records- a full batch review was performed from raw material to finished product which showed no issues were found with the manufacture of the device.4112- analysis of data provided by user/third party- information was provided by the complainant on 21 nov 24, confirming that no images of the device were available.And the procedure was not reported as extended.No further information was provided on the event.4117- device not accessible for testing - device remains implanted.Investigation findings (annex c) 4256 - malfunction observed without conclusive finding - due to the limited information provided by the complainant, and no issues being found with the manufacture of the device, no causal link between the event and the device could be determined.Investigation conclusion (annex d) 4315 - cause not established - malfunction observed without conclusive finding - due to the limited information provided by the complainant, and no issues being found with the manufacture of the device, no causal link between the event and the device could be determined.

• Brand Name: GELSOFT PLUS
• Common Device Name: GELSOFT PLUS BIFURCATE
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business 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: 20681858
• Report Number: 9612515-2024-00079
• Device Sequence Number: 7229808
• Product Code: DSY
• UDI-Device Identifier: 05037881115535
• UDI-Public: 05037881115535
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K955230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2024

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: 631809P-G
• Device Lot Number: 25702131
• 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: 10/16/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2024
• 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: Required Intervention; Other
• Patient Sex: Unknown