MAUDE Adverse Event Report: VASCUTEK LTD; GELSOFT STRAIGHT

Catalog Number	633008-G
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturers narrative (h6).Clinical code: 4580 insufficient information: lack of information provided by complainant.Impact code: 4648 insufficient information: lack of information provided by complainant.Medical device problem: 3191 appropriate term/code not available: leakage to 8mm graft on unknown location.Component code: 4755 appropriate term/code not available.Type of investigations: 4110 trend analysis: 5-year preliminary investigation was performed which gave an occurrence rate of (b)(4).4111 communication/interview's: additional information was received by site on29 sep 23 which confirmed the graft was not soak before use.3331 analysis of production records: full batch review was performed which showed no issues with manufacturing of this product or raw materials.Investigation findings: 115 maintenance problem identified: the graft was not soaked before it was used.Investigation conclusion: 18 cause traced to user failure to follow instructions: as per ifu 301-174_3 polyester multi product usa section 1.6 it states, gelsoft protheses should be immersed completely on a sterile solution for 5 minutes.The prothesis must not be allowed to dry out after soaking.This was also reported directly to fda by complainant, the report number was (b)(4).
Event or Problem Description
Leakage of blood from 8 mm knitted dacron graft by vascutec.8mm gelsoft graft leaking during operation on a 70 year old male, date of event (b)(6) 2023, reported direct to fda under (b)(4) jul 23 , reported to vascutek (b)(6) 2023.This report has been submitted as initial/ final for mfg.
Additional Manufacturer Narrative
Additional information , correcting the expiry date of the device in section d4.
Event or Problem Description
This report is being submitted as follow up 1 for manufacturing report no 9612515-2023-00023 to correct the device expiry date.

• Common Device Name: GELSOFT STRAIGHT
• 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: jason whittle ; newmains avenue; inchinnan; glasgow, PA49R-R ; UK PA49RR
• MDR Report Key: 17928610
• Report Number: 9612515-2023-00023
• Device Sequence Number: 12371045
• Product Code: DSY
• UDI-Device Identifier: 05037881110240
• UDI-Public: 05037881110240
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K990503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2024

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: 08/31/2023
• Device Catalogue Number: 633008-G
• Device Lot Number: 21476737
• 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: 09/18/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2020
• 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: 70 YR
• Patient Sex: Male