MAUDE Adverse Event Report: Vascutek Ltd. Gelsoft; Gelsoft Plus Bifurcate

Model Number	N/A
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Gelsoft plus bifurcate being implanted in a 44 year old male patient at (b)(6).A medial approach to the arm was made along the vascular pathway.Dissection was performed through layers until the brachial vein and superficial cutaneous brachial nerve were identified.Dissection of the deep layer was then performed, identifying the median nerve, brachial artery, and vein.The dissection extended into the axillary region, revealing no lesions at this level.Dissection continued distally, identifying the findings described 2 cm above the antecubital fossa.The proximal and distal edges of the brachial artery were reshaped.The brachial vein was ligated.A fogarty suture no.3-4-5 was passed proximally and distally, obtaining a single, fresh blood clot.The proximal and distal areas were irrigated with heparinized saline solution.A 6mm dacron graft was placed with a proximal double-pillar anastomosis.Upon verifying the adequate seal of the anastomosis, it was confirmed that hemorrhagic leakage was identified throughout the graft, so it was decided to remove it.No harm to the patient was noted , however it was considered a serious adverse event due to the increased surgery time.This report is being submitted as follow up #1 to provide event closure information for (b)(4).
Additional Manufacturer Narrative
Manufacturer narrative: clinical code: e; 1888 - haemorrhage/ bleeding -blood leakage reported throughout the gelsoft plus bifurcate.Impact code: f; 4627- device explanted - as the leakage occurred throughout the bifurcate graft it was explanted.Device problem code: a; 2978 - material integrity problem - leakage occurred throughout the bifurcate graft.Component code: g; 4755 - part/component/sub-assembly term not applicable.Type of investigation: b; 4110 - trend analysis: - gelsoft plus sales jan 22 -jun 26 vs gelsoft(plus) leakage > blood oozing events (b)(6) 2026 had an occurrence rate of (b)(4) no trend requiring action has been identified.4111 - communication interview: additional information was requested on 30 jun, 07 jul 26 to determine whether the gelatin coating on the graft appeared intact and uniform.Clarification was requested regarding the patient's activated clotting time (act) or activated partial thromboplastin time (aptt) score and whether it was within the expected range for the procedure being carried out.Information was also requested on the volume of blood loss and the time period over which the blood loss occurred.Further questions addressed the handling of the graft prior to implantation, including whether the graft was soaked in saline before use, the duration of soaking, and whether the graft was allowed to dry out at any point during the procedure.The investigation also sought to understand whether the gelatin coating could have been damaged during the procedure.In addition, clarification was requested regarding the availability of the device for return, as the intake form indicated that the device was not available to be returned, and whether the device had been discarded.Finally, the availability of any images showing the leakage was requested.No additional information was received.3331 - analysis of production records: full batch review performed from base fabric to finished product for device id- 25359747 which confirmed the batch was manufactured to specification.4114 - device not returned: device was explanted but is not available for return.Investigation findings: c: 213 - no device problem found - as the full batch review confirmed the batch was manufactured to specification with no issues found and the acceptance criteria for the porosity of the grafts are lower limit - 0.000 ml/ min and upper limit of 58.000 ml/ min with the results for the 10 devices in this batch of product being between 2.000 ml/ min and 26 ml/ min, all grafts porosity results have been within specification investigation conclusion: d: 4315 - cause not established - as all devices have been manufactured to specification and as we have no additional information available regarding any potential gelatin or pre-soak issue root cause analysis of this event could not be performed and no causal link between the event and the device could be established.

• Brand Name: Gelsoft
• Common Device Name: Gelsoft Plus Bifurcate
• Manufacturer (Section D): Vascutek Ltd.; newmains avenue; inchinnan buisness park; glasgow, renfrewshire PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): Vascutek Ltd.; newmains avenue; inchinnan buisness park; glasgow, renfrewshire PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: laura allan ; newmains avenue; inchinnan buisness park; glasgow, renfrewshire PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 25869386
• Report Number: 9612515-2026-00039
• Device Sequence Number: 12776844
• Product Code: DSY
• UDI-Device Identifier: 05037881115504
• UDI-Public: 05037881115504
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K955230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2026

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: 06/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 631206P-G
• Device Lot Number: 25359747
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2026
• Supplement Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 07/20/2026
• Supplement Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/25/2023
• 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 Age: 44 YR
• Patient Sex: Male