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

Model Number	00884450033289
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect medical device has been returned for evaluation.The device was visually and microscopically investigated.The complaint is confirmed.The root cause could not be determined however, it is likely that significant force was applied to the device during clinical use.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and two similar complaints for this lot number were identified.
Event or Problem Description
The account alleges that during a percutaneous transhepatic biliary drainage (ptbd) procedure, the access wires black jacket detached within the patient while attempting access to the patient's biliary system.The physician successfully externalized the foreign body by removing the foreign body (jacket) by hand, liberating the patient from the foreign body.No additional patient consequences to report.

• Brand Name: MERIT LAUREATE® WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; parkmore business park west; ballybrit, galway ; EI
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS; parkmore business park west; ballybrit, galway ; EI
• Manufacturer Contact: bryson heaton bsn,rn. ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 17353670
• Report Number: 9616662-2023-00009
• Device Sequence Number: 6016767
• Product Code: DQX
• UDI-Device Identifier: 00884450033289
• UDI-Public: 00884450033289
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/17/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/10/2025
• Device Model Number: 00884450033289
• Device Catalogue Number: LWSTDA35150/D
• Device Lot Number: K2594240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ACCESS NEEDLE
• Patient Sex: Unknown