MAUDE Adverse Event Report: MERIT MEDICAL IRELAND, LTD. INQWIRE®; CARDIAC CATHETER GUIDEWIRE, SINGLE-USE

Catalog Number	IQ35F180J1O5RS/B
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The account alleges during a procedure the wire was stuck at the catheter tip after being pulled back into the right atrium from the left.The physician was unable to advance or withdraw the wire.Upon close examination, it seems there was a piece of fiber/plastic that had peeled off.A new device was used to complete the procedure.
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The investigation identified significant damage to the guidewire.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®
• Common Device Name: CARDIAC CATHETER GUIDEWIRE, SINGLE-USE
• Manufacturer (Section D): MERIT MEDICAL IRELAND, LTD.; parkmore business park west; ballybrit, galway H91W2 74; EI H91W274
• Manufacturer (Section G): MERIT MEDICAL IRELAND, LTD.; parkmore business park west; ballybrit, galway H91W2 74; EI H91W274
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 24199298
• Report Number: 1721504-2026-00843
• Device Sequence Number: 9624768
• Product Code: DQX
• UDI-Device Identifier: 00884450019467
• UDI-Public: 00884450019467
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K002289
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• 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
• Device Catalogue Number: IQ35F180J1O5RS/B
• 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: 01/16/2026
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown