MAUDE Adverse Event Report: MERIT MEDICAL IRELAND, LTD. INQWIRE®; PERIPHERAL VASCULAR GUIDEWIRE

Catalog Number	IQ35F180J1O5RS
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	12/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The account alleges there was tissue entrapment between the tip of the catheter and the catheter.The physician retracted the guidewire but there was resistance, once the catheter was removed from the body, there was fibrous tissue in between the wire and the tip of the catheter.Afterwards the tissue was removed with surgical equipment from the guidewire but the guidewire was still stuck inside the lumen of the catheter.Resulting in removal of the guidewire from the front end of catheter.A new guidewire was used for the remainder of the case.The ablation was completed.
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.Nonconformances of this nature are monitored by the operation team.This complaint will be used to trend for similar complaints.

• Brand Name: INQWIRE®
• Common Device Name: PERIPHERAL VASCULAR GUIDEWIRE
• 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: 24119435
• Report Number: 1721504-2026-00830
• Device Sequence Number: 14971398
• Product Code: DQX
• UDI-Device Identifier: 00884450019467
• UDI-Public: 00884450019467
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/20/2026

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 01/20/2026
• 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