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

Model Number	N/A
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Clinical code: 4582 - no clinical signs, symptoms or conditions: no patient consequences were identified during initial event intake form.Health impact: 2199 - no health consequences or impact: no patient consequences were identified during initial event intake form.Medical device problem: 1494 - off- label use: the device is contraindicated for ex anantomical use.Component code: 4755 - part/component/sub-assembly term not applicable.Type of investigation: 4110 - trend analysis: 4 year review was performed for leakage > event description (circulation line) with gave an occurrence rate of (b)(4).Increasing trend was identified requiring action at this time.4111 - communication/interview: awaiting further information from the site.3331 - analysis of production records: a comprehensive batch review was performed to review the manufacturing process from raw materials to finished product.No issues were identified.No causal link was identified between the device and the event.4117 - device not accessible for testing: device not returned by the site for testing.Investigation findings: 3233 - results pending completion of investigation: investigation conclusion: 11 - conclusion not yet available:.
Event or Problem Description
Event date: on 16 oct 2024.Implant date: on (b)(6) 2024.Event was reported as weaving defects.The surgical graft was used as a circulation line for aortic replacement procedure, and after clamp released, surgeon found blood eject from the surface of surgical graft (not the anastomosis site).
Additional Manufacturer Narrative
Clinical code: 4582 - no clinical signs, symptoms or conditions: no patient consequences were identified during initial event intake form.Health impact: 2199 - no health consequences or impact: no patient consequences were identified during initial event intake form.Medical device problem: 1494 - off- label use: ifu 301-199 polyester multi-product row gelita set b states in section 1.3 contraindications.Gelsoft and gelsoft plus prosthesis are contraindicated for thoracic and extra anatomical use.Component code: 4755 - part/component/sub-assembly term not applicable.Type of investigation: 4110 - trend analysis: 4 year review was performed for leakage > event description (circulation line) with gave an occurrence rate of 0.002%.Increasing trend was identified requiring action at this time.4111 - communication/interview: additional information was received by the site which confirmed that: the size of the hole was 0.2mm-0.5mm and the hole was noticed when there was perfusion to the graft.The hole was fixed with a suture.Atraumatic clamp were used.The patient total blood loss was 10-15ml, the graft was used for bypass.The surgeon decided to use a gelsoft plus device instead of gelweave device for circulation line.There was no damage to graft before use and no further device was used.The patient was fine and without adverse event.3331 - analysis of production records: a comprehensive batch review was performed to review the manufacturing process from raw materials to finished product.No issues were identified.No causal link was identified between the device and the event.4117 - device not accessible for testing: device not returned by the site for testing.Investigation findings: 4248 - usage problem identified: ifu 301-199 polyester multi-product row gelita set b states in section 1.3 contraindications.Gelsoft and gelsoft plus prosthesis are contraindicated for thoracic and extra anatomical use.Investigation conclusion: 18 - failure to follow instructions: ifu 301-199 polyester multi-product row gelita set b states in section 1.3 contraindications.Gelsoft and gelsoft plus prosthesis are contraindicated for thoracic and extra anatomical use.The root cause of this event was determined to be off-label use.24 - cause traced to intentional off-label, unapproved, or contraindicated use: ifu 301-199 polyester multi-product row gelita set b states in section 1.3 contraindications.Gelsoft and gelsoft plus prosthesis are contraindicated for thoracic and extra anatomical use.
Event or Problem Description
Event date: 16 oct 2024, implant date: on (b)(6) 2024.Event was reported as weaving defects.The surgical graft was used as a circulation line for aortic replacement procedure, and after clamp released, surgeon found blood eject from the surface of surgical graft (not the anastomosis site).This report is being submitted as a follow up 1 for manufacturing report#: 9612515-2024-00077 to provide event closure information for tag0065.

• Brand Name: GELSOFT PLUS
• Common Device Name: GELSOFT PLUS STRAIGHT
• 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: 20650845
• Report Number: 9612515-2024-00077
• Device Sequence Number: 18197382
• Product Code: DSY
• UDI-Device Identifier: 05037881115238
• UDI-Public: 05037881115238
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2024

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: 08/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 633010P-G
• Device Lot Number: 25462144
• 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: 10/18/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2023
• 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
• Patient Sex: Unknown