MAUDE Adverse Event Report: VASCUTEK LTD GELWEAVE; GELWEAVE VALSALVA

Model Number	N/A
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufactures narrative: clinical code: 4582 -no patient involvement or, no observable clinical symptoms or a change in symptoms is identified in the patient.Impact code: 2645 - no patient involvement when the adverse event occurred (for example happened during set-up or cleaning).Device problem code: 4053 - patient labels were missing from the sealed unit box.Component code: 4755 - part/component/sub-assembly term not applicable.Type of investigation: 3331 - analysis of production records.4110 - trend analysis.4111 - communication/interview: awaiting further information from the site.4112 - analysis of data provided by user/third party.Investigation findings: 3233 - results pending completion of investigation.Investigation conclusion: 11 - cause not yet established.Additional information - section d9 - we have requested clarification on the disposition of the device , we have had no reply to date.Section h1 - we have selected malfunction although this is a missing label issue and none of the selections describe this accurately.
Event or Problem Description
Gelweave valsalva graft received with no implant stickers inside a brand new implant box.
Event or Problem Description
Gelweave valsalva graft received with no implant stickers inside a brand-new implant box.This report is being submited as a final for mfg report number to provide event closure information for tag0041.
Additional Manufacturer Narrative
Clinical code: e.4582 - no patient involvement or, no observable clinical symptoms or a change in symptoms is identified in the patient.Impact code: f.4656 - problem identified before clinical use/exposure.The lack of patient labels was identified as the device was unpacked.Device problem code: a.4053 - patient labels were missing from the sealed unit box.Patient labels are stuck to the patients medical records to record the device information.Component code: g.4755 - part/component/sub-assembly term not applicable.Type of investigation: b.3331 - analysis of production records- production records confirm that the patient labels were included in the packing of the device.4110 - trend analysis- a review of similar events for this complaint category (gelweave sales vs gelweave missing label events) gives a rate of 0.0004%.No trend requiring action was identified at this time.4111 - communication/interview: awaiting further information from the site- the complainant confirmed that the device of batch 25806192 was the only device affected.The device was implanted with no issues, and the information usually on a patient label was successfully transferred to the patients medical records with no loss of information.4112 - analysis of data provided by user/third party- the complainant confirmed that the device of batch 25806192 was the only device affected.The device was implanted with no issues, and the information usually on a patient label was successfully transferred to the patients medical records with no loss of information.Investigation findings: c.4245 - packaging contains incorrect or incomplete device- missing patient labels are confirmed to have been missing.Investigation conclusion: d.25 - cause traced to manufacturing - the event has been confirmed to be due to manufacturing procedures which have limited checks to confirm the presence of patient labels prior to final shipping.These procedures shall be updated via internal actions.

• Brand Name: GELWEAVE
• Common Device Name: GELWEAVE VALSALVA
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan buiness park; renfrewshire, glasgow PA49R R; UK PA49RR
• Manufacturer (Section G): VASCUTEK LTD; newmains avenue; inchinnan buiness park; renfrewshire, glasgow PA49R R; UK PA49RR
• Manufacturer Contact: laura allan ; newmains avenue; inchinnan buiness park; renfrewshire, glasgow PA49R-R ; UK PA49RR
• MDR Report Key: 20349898
• Report Number: 9612515-2024-00071
• Device Sequence Number: 8055336
• Product Code: DSY
• UDI-Device Identifier: 05037881120133
• UDI-Public: 05037881120133
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K013022
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2024

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 Model Number: N/A
• Device Catalogue Number: 730030ADP-G
• Device Lot Number: 25806192
• 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: 09/04/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 11/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2024
• 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