MAUDE Adverse Event Report: VASCUTEK LTD; GELSOFT STRAIGHT

Catalog Number 633008-G

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 06/29/2023

Event Type  Injury  

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 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.

Manufacturer Narrative

Additional information , correcting the expiry date of the device in section d4.

Event Description

This report is being submitted as follow up 1 for manufacturing report no 9612515-2023-00023 to correct the device expiry date.

• Type of Device: 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
• MDR Text Key: 325573122
• Report Number: 9612515-2023-00023
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881110240
• UDI-Public: 05037881110240
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/12/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2020
• Device Catalogue Number: 633008-G
• Device Lot Number: 21476737
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2023
• Initial Date FDA Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male