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

Catalog Number	IQ35F180J1O5RS/B
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
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
The account alleges that during a pvi procedure, the wire became difficult to maneuver when in the left veins.As the wire was being removed, it broke.An attempt was made to advance the wire and it was not able to.With excessive force, the wire was pulled back and broke.A second wire and catheter were used to complete the procedure.No patient injury.
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 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.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The investigation identified that the ribbon from the guidewire had broken away from the distal end during the procedure.No manufacturing defects were detected during a detailed inspection and measurement of the merit guide wire.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: 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: 23760521
• Report Number: 1721504-2025-00652
• Device Sequence Number: 10105324
• Product Code: DQX
• UDI-Device Identifier: 00884450019467
• UDI-Public: 00884450019467
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/23/2026

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: 11/13/2025
• Supplement Date Received by Manufacturer: 12/15/2025; 01/23/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 12/16/2025; 01/23/2026
• 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