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

Catalog Number	IQ35F260J3/B
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2025
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 during the coronary angiography procedure, while advancing the guidewire at the brachial artery, it bent at the junction with the floppy end, preventing it from advancing further into the vascular bed.The wire was removed and it was noted that the metal core of the guidewire was exposed and rigid.No patient injury.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.No manufacturing defects were detected during a detailed inspection and measurement of the merit guide wire.The nature of the damage (kinks, bends in the wire & core wire protrusion) identified during the investigation is consistent with the excessive force applied during the procedure resulting in core wire protrusion and penetration through the coil.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• 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: 23769984
• Report Number: 1721504-2025-00704
• Device Sequence Number: 9723124
• Product Code: DQX
• UDI-Device Identifier: 00884450011133
• UDI-Public: 00884450011133
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• 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,Followup
• Report Date (Section B): 01/07/2025

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: IQ35F260J3/B
• Device Lot Number: K3234384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown