MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MERIT LAUREATE.GUIDE WIRE; HYDROPHILIC GUIDE WIRE

Catalog Number	LWSTFA35180/D
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.
Event or Problem Description
The account alleges that during a procedure when introducing the hydrophilic guidewire into a 6f sheath, the black jacket detached from the hydrophilic guidwire.No foreign body introduction.No patient injury to report.A new guidewire was used to complete the procedure.

• Brand Name: MERIT LAUREATE.GUIDE WIRE
• Common Device Name: HYDROPHILIC GUIDE WIRE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; parkmore business park west; ballybrit, galway ; EI
• MDR Report Key: 11233421
• Report Number: 9616662-2021-00003
• Device Sequence Number: 3229257
• Product Code: DQX
• UDI-Device Identifier: 00884450033340
• UDI-Public: 884450033340
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/13/2021

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: 10/02/2023
• Device Catalogue Number: LWSTFA35180/D
• Device Lot Number: K1954769
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 01/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1