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

Catalog Number	IQ35F180J1O5RS/B
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Boston scientific forwarded a report from a customer alleging a problem advancing the guidewire.No patient complications.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.

• Brand Name: INQWIRE®
• 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: 23659574
• Report Number: 1721504-2025-00627
• Device Sequence Number: 15983467
• 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: EXEMPT
• 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
• Report Date (Section B): 11/26/2025

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
• Device Catalogue Number: IQ35F180J1O5RS/B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown