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

Catalog Number	IQ35F180J1O5RS/B
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that the farawave catheter was prepared per ifu and used for ablation in the left upper pulmonary vein without issue.When repositioning to the left lower pulmonary vein using a guidewire, the physician reported the wire became stuck and could not be advanced independently.The catheter and wire were removed together.Upon removal, the wire was found to have a partial outer-coil fracture but remained intact.The catheter functioned normally outside the body.Both devices were replaced, and the procedure was completed successfully with no patient injury.
Additional Manufacturer Narrative
The suspect medical device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.No lot number was provided, so no device history record review or complaint database could be performed.

• 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: 23780671
• Report Number: 1721504-2025-00710
• Device Sequence Number: 10105218
• Product Code: DQX
• UDI-Device Identifier: 00884450019467
• UDI-Public: 00884450019467
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• 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,Followup
• Report Date (Section B): 12/16/2025

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 12/16/2025
• 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