MAUDE Adverse Event Report: MERIT MEDICAL IRELAND INQWIRE.GUIDE WIRE; WIRE, GUIDE, CATHETER

Catalog Number	IQ35F180J1O5RS/B
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
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 established.A review of the device history and complaint database could not be performed since the lot number was not provided.
Event or Problem Description
Customer alleged another manufacture catheter was prepared according to all recommendations, after ablation of the left superior pulmonary vein (lspv) the physician was unable to push or pull the merit guidewire.It was completely stuck in the catheter.They removed the catheter and note the guidewire was damaged.A different guidewire was used to complete the procedure without issue.There were no patient complications.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The investigation determined that the ribbon had separated from the distal end during the procedure.No root cause was able to be confirmed.No device history record review or complaint database search were performed because no lot number was provided.

• Brand Name: INQWIRE.GUIDE WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MERIT MEDICAL IRELAND; parkmore business park west; galway H91 W 274; EI H91 W274
• Manufacturer (Section G): MERIT MEDICAL IRELAND; parkmore business park west; galway H91 W 274; EI H91 W274
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 23758887
• Report Number: 1721504-2025-00697
• Device Sequence Number: 10170464
• Product Code: DQX
• UDI-Device Identifier: 00884450019467
• UDI-Public: 00884450019467
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K133230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2026

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: IQ35F180J1O5RS/B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown