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

Catalog Number	IQA563
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The device was found to be damaged, scratched and the inner coil unravelling.The root cause of this defect could not be determined.A search of the complaint database was performed and fourteen similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.Nonconformances of this nature are monitored by the operation team.This complaint will be used to trend for similar complaints.
Event or Problem Description
The account alleges that during use the blue coating of the guidewire partially came off.This caused the drain to fail to track along the wire.A new wire was used to complete the procedure.No patient injury.

• 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: 23844998
• Report Number: 1721504-2025-00751
• Device Sequence Number: 9816906
• Product Code: DQX
• UDI-Device Identifier: 00884450239674
• UDI-Public: 00884450239674
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• 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): 12/18/2025

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: IQA563
• Device Lot Number: K3290177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown