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

Catalog Number	LWSTDA35260EX/CND
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges while performing a lower cavity filter removal surgery, the guide wire loop formation technique was used.When pulling the filter with the device, the end of the guide wire fell off within the patient.The foreign body was successfully retrieved.No additional patient consequence to report.
Additional Manufacturer Narrative
The suspect medical device is not expected to return for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.Should the device be returned later, the investigation will be reopened.

• 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: 22137599
• Report Number: 9616662-2025-00024
• Device Sequence Number: 12601705
• Product Code: DQX
• UDI-Device Identifier: 00884450033302
• UDI-Public: 00884450033302
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/12/2025
• Device Catalogue Number: LWSTDA35260EX/CND
• Device Lot Number: K2561701
• 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: 05/30/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2022
• 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 Sex: Unknown