MAUDE Adverse Event Report: Merit Medical Ireland InQwire.Guide Wire; Wire, Guide, Catheter

Catalog Number	IQA522
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2026
Type of Reportable Event	Malfunction

• Brand Name: InQwire.Guide Wire
• Common Device Name: Wire, Guide, Catheter
• Manufacturer (Section D): Merit Medical Ireland; parkmore business park west; galway H91 W 274; EI H91 W274
• Manufacturer (Section G): Merit Medical Ireland; parkmore business park west; galway H91 W 274; EI H91 W274
• Manufacturer Contact: lisa perz msn, rn, pmp ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 50529697
• Report Number: 9616662-2026-00046
• Device Sequence Number: 20343707
• Product Code: DQX
• UDI-Device Identifier: 00884450355961
• UDI-Public: 00884450355961
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K170700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Type of Report: Initial
• Report Date (Section B): 08/31/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: IQA522
• Device Lot Number: K32844790
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/26/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2026
• Initial Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown