MAUDE Adverse Event Report: VASCUTEK LTD. GELWEAVE; GELWEAVE STRAIGHT

Model Number GELWEAVE STRAIGHT

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 02/28/2024

Event Type  malfunction  

Event Description

Physician used a 8mm gelweave graft on his bentall case today.The graft oozed all over it's entire surface area, for the entire case.

Manufacturer Narrative

Manufacturer narrative: clinical code: 4580 - insufficient information: a/w additional information form site impact code: 4648 - insufficient information: a/w additional information form site medical device problem: 3190 - insufficient information: a/w additional information form site component code: 4755 - part/component/sub-assembly term not applicable type of investigation: 4110 - trend analysis: a 5 year review of similar complaints (gelweave sales v gelweave leakage events 24 jan 19 to jan 24 ) gave an occurrence rate of (b)(4) 4111 - communication interview: requested additional information 3331 - analysis of production records: full batch review performed.

Manufacturer Narrative

Manufacturer narrative: clinical code: 4580 - insufficient information: 3 attempts were made to obtain additional information on this event, no additional information was communicated.Impact code: 4648 - insufficient information: 3 attempts were made to obtain additional information on this event, no additional information was communicated.Medical device problem: 3190 - insufficient information: 3 attempts were made to obtain additional information on this event, no additional information was communicated.Component code: 4755 - part/component/sub-assembly term not applicable type of investigation: 4110 - trend analysis: (b)(4).4111 - communication interview: requested additional information no additional information was received 3331 - analysis of production records: full batch review performed which showed no issues with the device during manufacture from raw material to finished products investigation findings: 213 - no device problem found: a full batch review from raw material to finished product was performed which showed no issues in the manufacture of batch 22331888.Investigation conclusion: 4315 - cause not established : no causal factor between the event and the device could be determined.67 - no problem detected : no issue was found in the manufacture of batch 22331888.

Event Description

Physician used a 8mm gelweave graft on his bentall case today.The graft oozed all over it's entire surface area, for the entire case this report is being submitted as a follow up#1 for manufacturing report #9612515-2024-00018 to provide closure information for (b)(4).

• Brand Name: GELWEAVE
• Type of Device: GELWEAVE STRAIGHT
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; glasgow, renfrewshire PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): VASCUTEK LTD.; newmains avenue; inchinnan business park; glasgow, renfrewshire PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: jason whittle ; newmains avenue; inchinnan business park; glasgow, renfrewshire PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 18985073
• MDR Text Key: 339335378
• Report Number: 9612515-2024-00018
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881105079
• UDI-Public: 05037881105079
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952293
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/23/2024

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
• Device Model Number: GELWEAVE STRAIGHT
• Device Catalogue Number: 731508-G
• Device Lot Number: 22331888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/27/2024
• Supplement Dates Manufacturer Received: 02/29/2024
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/06/2022
• 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): Other