MAUDE Adverse Event Report: MERIT MEDICAL IRELAND LTD MERIT LAUREATE® GUIDE WIRE; WIRE, GUIDE, CATHETER

Catalog Number	LWSTDA35150/D
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A supplemental report will be submitted once the investigation is complete.
Event or Problem Description
The account alleges that during the procedure, while attempting to introduce an interventional device over the guidewire, the coating of the guidewire started coming off onto the operator's gloves.No additional patient consequence to report.
Event or Problem Description
The account alleges that during the procedure, while attempting to introduce an interventional device over the guidewire, the coating of the guidewire started coming off onto the operator's gloves.No additional patient consequence to report.
Additional Manufacturer Narrative
The suspect medical device has not been returned for engineering evaluation.The internal manufacturing process was reviewed.All products have been found to be in compliance with the manufacturing standards.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were identified.A search of the complaint database was performed and no similar complaints with this lot number were identified.

• Brand Name: MERIT LAUREATE® GUIDE WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MERIT MEDICAL IRELAND LTD; parkmore business park west; ballybrit; galway, ; EI
• Manufacturer (Section G): MERIT MEDICAL IRELAND LTD; parkmore business park west; ballybrit; galway, ; EI
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 21435246
• Report Number: 9616662-2025-00002
• Device Sequence Number: 11913664
• Product Code: DQX
• UDI-Device Identifier: 00884450033289
• UDI-Public: 00884450033289
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K141295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2025

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 Catalogue Number: LWSTDA35150/D
• Device Lot Number: K3096492
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2024
• 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
• Patient Sex: Unknown