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

Model Number	GELSOFT PLUS BIFURCATE
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022 a patient underwent significant thoraco abdominal surgeries where four individual grafts were implanted (x1 gelweave trifurcate, x1 coselli, x1 gelweave straight and x1 gelsoft plus bifurcate).On (b)(6) 2022 infection was detected and it was indicated that the gelsoft plus bifurcate graft which was implanted is the cause as there are no signs of infection with the other three grafts implanted.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Investigation findings: 3221 - no findings are available - the site performed culture testing of the alleged infection material from the implant site.Despite multiple requests for the findings of this analysis, teh results have not been communicated to vascutek ltd.; therefore it is impossible to determine a root cause.Investigation conclusions: 4315 - cause not established - vascutek ltd.Products are sterilised using 100% ethylene oxide which is a bactericidal chemical.The sterilisation process is fully validated ensuring a sterility assurance level (sal) of 10-6 using bacillus atrophaeus biological indicators.As no issues with the sterile barrier packaging was reported to us, this would indicate that when the graft was opened from its protective packaging, it was sterile.Unfortunately as the results of the culture testing performed by the site was not provided; it has not been possible to determine the type and modality of the reported infection; therefore no determination of root cause is possible.
Event or Problem Description
Event information updated from the initial report.On (b)(6) 2022, a patient had multiple grafts (x4) manufactured by vascutek ltd.Implanted (x3 gelweave branded devices & x1 gelsoft plus) in an extensive thoracoabdominal procedure.The site stated that all grafts were pre-soaked in rifampicin prior to implant.On 07 may 22 an incidental finding of infection was detected during an intervention procedure to arrest a bleeding issue.During the procedure all implanted grafts appeared to have a yellow coloured substance with a soft consistency on and around the grafts.This material was washed off the grafts, but the gelsoft bifurcate did not appear as clean as the others.The site indicated that it was believed that the gelsoft device may be the source.; though also indicated that the procedure itself may have been a factor.A sample of the yellow coloured substance was extracted and issued to the facility's laboratories for testing.

• Brand Name: GELSOFT PLUS
• Common Device Name: GELSOFT PLUS BIFURCATE
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan; glasgow, renrewshire PA49R R; UK PA49RR
• Manufacturer (Section G): VASCUTEK LTD; newmains avenue; inchinnan; glasgow, renrewshire PA49R R; UK PA49RR
• Manufacturer Contact: jason whittle ; newmains avenue; inchinnan; glasgow, renrewshire PA49R-R ; UK PA49RR
• MDR Report Key: 14630165
• Report Number: 9612515-2022-00006
• Device Sequence Number: 20377741
• Product Code: DSY
• UDI-Device Identifier: 05037881115566
• UDI-Public: 05037881115566
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K955230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: GELSOFT PLUS BIFURCATE
• Device Catalogue Number: 632412P-G
• Device Lot Number: 22233666
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2022
• 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: Male