MAUDE Adverse Event Report: VASCUTEK LTD GELSOFT PLUS; GELSOFT PLUS BIFRCATE

Model Number	N/A
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During an axillo-femoral bypass, the bifuricated graft lot 2003294573 was used.The surgeon noted that there was a preexisting hole in the bifuricated graft which was discovered during surgery.The patient experienced blood loss when the graft was in situ, at which point the hole was found to be in the bifuricate graft.The graft remained implanted and the hole repaired with a patch of unused graft material.This report is being submited as a follow up #2 for mfg report number 9612515-2024-00044 to provide event closure information for tag0008 (b)(4).
Additional Manufacturer Narrative
Manufacturer narrative: clinical code: 1888 - haemorrhage/ bleeding: blood loss from a hole found in the bifurcated graft.Impact code: 4630- modified surgical procedure: surgical patch was used to repair the hole in the graft.Device problem code : 1504 - material puncture /hole: a hole was identified in the bifurcated graft.Component code: 4755 - part/component/sub-assembly term not applicable.Type of investigation: 4114 - device not accessible for testing - device remains implanted.4110 - trend analysis: a 5 year review of similar complaints (gelweave sales vs gelweave leakage > hole/ pinhole) gave an occurrence rate of (b)(4) (complaints v sales).There have been no similar complaints received from other units of the same batch.No negative trend in the number of complaints received has been identified.4111 - communication/interviews: the site confirmed on 12 aug 24 that no further information would be provided.3331 - analysis of production records: batch review performed which showed no issues with the device during manufacture.No causal link between the device and the event could be determined, no corrective or further actions could be determined.Investigation findings: 213 - no device probelm found: batch review performed which showed no issues with the device during manufacture.No causal link between the device and the event could be determined, no corrective or further actions could be determined investigation conclusion: 4315 - cause not established: as no further evidence can not be obtained, the investigation could not be completed and no causal link between the device and the event could be determined.Update to below sections for gdp: section b5; section d3 & g1.
Additional Manufacturer Narrative
Manufacturer narrative: clinical code: 1888 - haemorrhage/ bleeding: blood loss from a hole found in the bifurcated graft.Impact code: 4630- modified surgical procedure: surgical patch was used to repair the hole in the graft.Device problem code: 1504 - material puncture /hole: a hole was identified in the bifurcated graft.Component code: 4755 - part/component/sub-assembly term not applicable type of investigation: 4114 - device not accessible for testing - device remains implanted.4110 - trend analysis: a 5 year review of similar complaints (gelweave sales vs gelweave leakage > hole/ pinhole) gave an occurrence rate of 0.016% (complaints v sales).There have been no similar complaints received from other units of the same batch.No negative trend in the number of complaints received has been identified.4111 - communication/interviews: the site confirmed on 12 aug 2024 that no further information would be provided.3331 - analysis of production records: batch review performed which showed no issues with the device during manufacture.No causal link between the device and the event could be determined, no corrective or further actions could be determined.Investigation findings: 213 - no device problem found: batch review performed which showed no issues with the device during manufacture.No causal link between the device and the event could be determined, no corrective or further actions could be determined investigation conclusion: 4315 - cause not established: as no further evidence can not be obtained, the investigation could not be completed and no causal link between the device and the event could be determined.
Event or Problem Description
During an axillo-femoral bypass, the bifuricated graft lot 2003294573 was used.The surgeon noted that there was a preexistinghole in the bifuricated graft which was discovered during surgery.The patient experienced blood loss when the graft was in situ, at which point the hole was found to be in the bifuricate graft.The graft remained implanted and the hole repaired with a patch of unused graft material.This report is being submitted as a follow up #1 for mfg report number 9612515-2024-00044 to provide event closure information for (b)(4).
Additional Manufacturer Narrative
Manufacturer narrative: clinical code: 1888 - haemorrhage/ bleeding - blood loss from a hole found in the bifurcated graft.Impact code: 4630- modified surgical procedure - surgical patch was used to repair the hole in the graft.Device problem code: 5104 - a hole was identified in the bifurcated graft.Component code: 4755 - part/component/sub-assembly term not applicable type of investigation: 4114 - device not accessible for testing - device remains implanted.4110 - trend analysis: a 5 year review of similar complaints (gelweave sales vs gelweave leakage > hole/ pinhole) gave an occurrence rate of 0.016% (complaints v sales).There have been no similar complaints received from other units of the same batch.4112 - analysis of information provided by a user or third party.3331 - analysis of production records: batch review performed which showed no issues with the device during manufacture.Investigation findings: 3233 - results pending completion of investigation.Investigation conclusion: d11 - conclusion not yet available as investigation is ongoing.
Event or Problem Description
During an axillo-femoral bypass, the bifurcated graft lot 2003294573 was used.The surgeon noted that there was a pre-existing hole in the bifurcated graft which was discovered during surgery.The patient experienced blood loss when the graft was in situ, at which point the hole was found to be in the bifurcated graft.The graft remained implanted and the hole repaired with a patch of unused graft material.

• Brand Name: GELSOFT PLUS
• Common Device Name: GELSOFT PLUS BIFRCATE
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan buiness park; renfrewshire, glasgow PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): VASCUTEK LTD; newmains avenue; inchinnan buiness park; renfrewshire, glasgow PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: laura allan ; newmains avenue; inchinnan buiness park; renfrewshire, glasgow PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 19622512
• Report Number: 9612515-2024-00044
• Device Sequence Number: 20416586
• Product Code: DSY
• UDI-Device Identifier: 05037881115511
• UDI-Public: 05037881115511
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K955230
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2024

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 Expiration Date: 08/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 631407P
• Device Lot Number: 25474195
• 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: 06/05/2024
• Supplement Date Received by Manufacturer: 06/05/2024; 06/05/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 08/27/2024; 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/21/2023
• 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; Required Intervention
• Patient Sex: Unknown