MAUDE Adverse Event Report: Vascutek LTD Gelsoft Plus Straight

Model Number	N/A
Medical Device Problem Codes	Microbial Contamination of Device (2303); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Post Operative Wound Infection (2446); Wound Infection (2447)
Date of Event	06/08/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical code: 2446 - post operative wound infection: site reported that on post-operatively (on pod 28 - (b)(6) 2026), the patient presented with the serious adverse event of wound infection.Impact code: 4607 - hospitalization or prolonged hospitalization: the patient was admitted to the emergency department with high fever and pain in the left groin.The patient was admitted to hospital on (b)(6) 2026.4641 - unexpected medical intervention: the patient was treated by intravenous amoxicillin/clavulanic acid therapy.The patient subsequently underwent surgical wound debridement of the left groin, drainage of the abscess, and placement of a vac (vacuum-assisted closure) device.Medical device problem: 2303 - microbial contamination of device: the site reported suspected graft infection.Component code: 4755 - part/component/sub-assembly term not applicable: type of investigation: 4110 - four-year review was performed for gelsoft > medical event > infection (b)(6) - (b)(6), this gave an occurrence score of 0.007%.No trend identified requiring action at this time.Investigation findings: 3233 - results pending completion of investigation.Investigation conclusion: 11 - conclusion not yet available: 22 - known inherent risk of device: within ifu (instruction for use) 301-218_1 gelsoft plus sygma ifu rev 2.0 section 8 potential adverse events graft infection.
Event or Problem Description
Event reported from panther study.Panther - (b)(6).Subject (b)(6), a 66 year-old, white, male with occlusive disease, underwent open surgical repair of femoropopliteal artery bypass with a gelsoft plus straight graft on (b)(6) 2026.There were no reported issues with the device following the surgery, and the patient was discharged back to pre-op living conditions on pod(post operative day) 5.Post-operatively (on pod 28 - (b)(6) 2026), the patient presented with the serious adverse event of wound infection.The patient was admitted to the emergency department with high fever and pain in the left groin.Clinical assessment indicated a postoperative wound infection following a femoropopliteal bypass, with suspected bypass graft infection (gelsoft plus device).The patient was admitted to hospital on (b)(6) 2026 where intravenous amoxicillin/clavulanic acid therapy was initiated.The patient subsequently underwent surgical wound debridement of the left groin, drainage of the abscess, and placement of a vac (vacuum-assisted closure) device.The site reported this event on (b)(6) 2026, at which time the event is still ongoing.).

• Brand Name: Gelsoft Plus Straight
• Common Device Name: Gelsoft Plus S
• Manufacturer (Section D): Vascutek LTD; newmains avenue; inchinnan buiness 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: 25677486
• Report Number: 9612515-2026-00032
• Device Sequence Number: 19997768
• Product Code: DSY
• UDI-Device Identifier: 05037881166643
• UDI-Public: 05037881166643
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K955230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2026

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: 634006PE
• Device Lot Number: 26422603
• 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: 06/09/2026
• Supplement Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 07/01/2026
• Supplement Report FDA Received Date: 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2026
• 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
• Patient Race: White