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

Model Number	N/A
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Event date: 28 aug 2024.Implant date: on (b)(6) 2024.During the surgery, the doctor finished suture and found a hole in the product.And they found blood flowing in the product.There was no injury or death.
Additional Manufacturer Narrative
Clinical code: 4582 - no clinical signs, symptoms or conditions- event intake form state's there was no injury to the patient.Also additional information from the site confirms the patient is well and recovering.Impact code: 2199 - no health consequences or impact- event intake form state's there was no injury to the patient.Also additional information from the site confirms the patient is well and recovering.4641 - unexpected medical intervention- the site covered the hole with hemostatic gauze for a short time.Medical device problem: 1504 - material puncture/hole- as reported on event intake form, the doctor found a hole on the device that was the size of one suture.Component code: 4755 - part/component/sub-assembly term not applicable.Type of investigation: 4110 - tend analysis: 4-year review was performed which gave an occurrence rate of (b)(4), no negative trend was identified requiring action at this time.4111 - communication/interviews- additional information was received on 05 sep 24.This confirmed the below: the size of the hole was one suture size and the hole was noticed after the implantation.The atraumatic clamps were not used near the hole, and the graft did not feel any different than usual.The hole was covered with hemostatic gauze for a short time.The patient is well and recovering.There was no damage to the graft before or during the operation.Also, there were no issues with positioning of the graft to fit the patient anatomy.The amount of blood loss was unknown but the bleeding stopped after the heparin was reversed.4117 - device not accessible for testing- the site confirmed the device remains implanted.Investigation findings: 3233 - results pending completion of investigation.Investigation conclusion: 11 - conclusion not yet available.
Additional Manufacturer Narrative
Clinical code: 4582 - no clinical signs, symptoms or conditions- event intake form state's there was no injury to the patient.Also additional information from the site confirms the patient is well and recovering.Impact code: 2199 - no health consequences or impact- event intake form state's there was no injury to the patient.Also additional information from the site confirms the patient is well and recovering.4641 - unexpected medical intervention- the site covered the hole with hemostatic gauze for a short time.Medical device problem: 1504 - material puncture/hole- as reported on event intake form, the doctor found a hole on the device that was the size of one suture.Component code: 4755 - part/component/sub-assembly term not applicable- type of investigation: 4110 - trend analysis: 4-year review was performed which gave an occurrence rate of 0.004%, no negative trend was identified requiring action at this time.4111 - communication/interviews- additional information was received on (b)(6) 2024.This confirmed the below: the size of the hole was one suture size and the hole was noticed after the implant.The atraumatic clamps were not used near the hole, and the graft did not feel and difference than usual.The hole was covered with hemostatic gauze for a short time.The patient is well and recovering.There was no damage to the graft before or during the operation.Also there was no issues with positioning of the graft to fit the patient anatomy.The amount of blood loss was unknown but the bleeding stopped after the heparin was reversed.4117 - device not accessible for testing- the site confirmed the device remains implanted.3331 - analysis of production record: comprehensive batch review was performed, no issues were identified during manufacturing process.No causal link between the event and device has been identified.Investigation findings: 3221 - no finding available: due to device not being available for return an inspection of the device could not be performed and a definitive root cause could not be identified investigation conclusion: 4315 - cause not established: due to device not being available for return an inspection of the device could not be performed and a definitive root cause could not be identified.
Event or Problem Description
Event date: 28 aug 24, implant date: (b)(6) 2024.During the surgery, the doctor finished suture and found a hole in the product.And they found blood flowing in the product.There was no injury or death.This report is being submitted as a follow up 1 for manufacturing report # 9612515-2024-00067 to provide event closure information for (b)(4).

• Brand Name: GELSOFT PLUS
• Common Device Name: GELSOFT PLUS BIFURCATE
• 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: 20291296
• Report Number: 9612515-2024-00067
• Device Sequence Number: 12564958
• Product Code: DSY
• UDI-Device Identifier: 05037881115535
• UDI-Public: 05037881115535
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2024

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: 02/28/2026
• Device Model Number: N/A
• Device Catalogue Number: 631809P
• Device Lot Number: 25269172
• 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: 08/29/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2023
• 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: Other; Required Intervention
• Patient Sex: Male