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

Model Number	N/A
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Event date: (b)(6) 2024.Implant date: (b)(6) 2024.The patient underwent vascular graft replacement to treat an abdominal aortic aneurysm.After anastomosis of the proximal portion, blood leakage occurred from the y-graft bifurcation.The damaged site was then repaired on site, and the surgery was continued.Subsequently, the surgery was successfully completed.Operation type: vascular graft replacement for abdominal aortic aneurysm blood loss: unknown this report is being submitted as an initial- final to provide event closure information for tag0075.
Additional Manufacturer Narrative
Clinical code: 1888: hemorrhage/blood loss/bleeding- blood leakage from the y-graft bifurcation.Impact code: 2199: no health consequences or impact- no health damage to the patient.Device problem code: 2017: improper or incorrect procedure or method- additional information received on 07 nov 24- the device was not soaked in saline solution before use as per the ifu 301-199 polyester multi-product row gelita set b "instructions for use".Component code: 4755 - part/component/sub-assembly term not applicable.Type of investigation: 4110 - trend analysis: a 4-year review of similar complaints gelsoft plus sales jan 21 - sep 24 vs bifurcation blood oozing type jan 21 - nov 24 gave an occurrence rate of (b)(4).No trend requiring action has been identified.4111 - communication interview: additional information received on 07 nov 24 confirming the device not soaked in saline solution for 5 minutes before use.3331 - analysis of production records: a full batch review was performed for batch id: 25296812, and no issues were identified during manufacturing process from raw materials to finished products.4117 - device not returned: device remains implanted investigation findings: 4248- usage problem identified: from the investigation performed and with all findings it was confirmed the ifu- instructions for use was not followed.Investigation conclusion: 18- failure to follow instructions: the site confirmed ifu usage- instruction for use procedure was not followed.

• Brand Name: GELSOFT PLUS
• Common Device Name: GELSOFT PLUS BIFURCATE
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan; glasgow, PA49R R; UK PA49RR
• Manufacturer (Section G): VASCUTEK LTD; newmains avenue; inchinnan; glasgow, PA49R R; UK PA49RR
• Manufacturer Contact: laura allan ; newmains avenue; inchinnan; glasgow, PA49R-R ; UK PA49RR
• MDR Report Key: 21197631
• Report Number: 9612515-2025-00006
• Device Sequence Number: 7577997
• Product Code: DSY
• UDI-Device Identifier: 05037881115542
• UDI-Public: 05037881115542
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/21/2025

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 Expiration Date: 05/21/2025
• Device Model Number: N/A
• Device Catalogue Number: 632010P-J
• Device Lot Number: 25296812
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2023
• 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: Required Intervention
• Patient Sex: Unknown