MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. INQWIRE GUIDEWIRE

Catalog Number	IQ35F180J1O5RS/B
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.The complaint cannot be confirmed and a root cause cannot be determined.A review of the device history record and complaint database cannot be performed as a lot number was not provided.
Event or Problem Description
The account alleges that the electrode/guidewire became stuck inside the device.Competitor catheter was replaced with no patient complications.

• Brand Name: INQWIRE GUIDEWIRE
• Common Device Name: GUIDEWIRE
• 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.; parkmore business park west; galway, H91 W 274; EI H91 W274
• Manufacturer Contact: adrian cole ; 1600 w merit pkwy; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 23692645
• Report Number: 1721504-2025-00683
• Device Sequence Number: 10192328
• Product Code: DQX
• UDI-Device Identifier: 00884450019467
• UDI-Public: 00884450019467
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/02/2025

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: IQ35F180J1O5RS/B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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