MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. SPLASHWIRE GUIDE WIRE

Catalog Number	MSWSTFA35180
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that the coating came off in the middle of the wire during a crossover maneuver.After using the flush catheter, the physician wanted to guide a sheath over the wire, but the dilator outside the patient blocked the wire.The procedure was continued with a new splashwire and completed successfully.There was a delay of approximately 10 minutes for the entire procedure.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed.The nature of the damage suggested that it was possibly caused during the torquing of the device.A search of the complaint database was performed and no similar complaints for this lot number were found.Nonconformances of this nature are monitored by the operation team.This complaint will be used to trend for similar complaints.

• Brand Name: SPLASHWIRE GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; parkmore business park west; galway, H91 W 274; EI H91 W274
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 1600 w merit pkwy; south jordan UT 84095
• Manufacturer Contact: adrian cole ; 1600 w merit pkwy; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 22849149
• Report Number: 1721504-2025-00278
• Device Sequence Number: 4461543
• Product Code: DQX
• UDI-Device Identifier: 00884450529355
• UDI-Public: 00884450529355
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K201595
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2025

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: MSWSTFA35180
• Device Lot Number: K3063922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: 09/14/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2024
• 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