MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. INQWIRE; WIRE, GUIDE, CATHETER

Model Number	00884450005156
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
>70 year-old male with past history of mitral valve replacement and recent chest pain with pleural effusion.Procedure: cardiac catheterization.When the merit medical, inqwire was opened, there was a dark hair found in the plastic coupler of the j wire.Not used on patient.Manufacturer response for wire, guide, catheter, inqwire (per site reporter).

• Brand Name: INQWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit parkway; south jordan UT 84095
• MDR Report Key: 20237392
• Report Number: 20237392
• Device Sequence Number: 8754935
• Product Code: DQX
• UDI-Device Identifier: 00884450005156
• UDI-Public: (01)00884450005156(17)270421(10)K2924877
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/26/2024
• Report Date (Section F): 08/26/2024

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 Model Number: 00884450005156
• Device Catalogue Number: IQ35F150J3/B
• Device Lot Number: K2924877
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/17/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/17/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 71 KG
• Date Report Sent to FDA: 08/26/2024