BEUDAMED
    FDA Adverse Event Summary report: N

    ARGON MEDICAL DEVICES

    MDR report key: 5306917 · Received December 17, 2015

    Report

    Report Number
    1047429-2015-00009
    Date Received
    December 17, 2015
    Date of Event
    December 1, 2015
    Report Date
    December 17, 2015
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    MOF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AVID MEDICAL IS THE MANUFACTURER OF A CUSTOM PROCEDURE TRAY THAT CONTAINS A GUIDEWIRE PART # 085210 MANUFACTURED BY ARGON MEDICAL DEVICES. AVID MEDICAL RECEIVED A COMPLAINT ON 12/1/2015 ORIGINATED BY (B)(4), VALUE STREAM LEADER OF OHIO STATE UNIVERSITY MEDICAL CENTER STATING THAT DURING PROCEDURES THEY HAD ONE GUIDEWIRE UNRAVEL AT THE TIP AND THREE GUIDEWIRES CRIMPED ABOUT 5 INCHES DOWN THE WIRE. MS. (B)(4) HAS BEEN UNABLE TO PROVIDE A LOT #, HOWEVER ONE OF THE COMPLAINED GUIDEWIRES WAS SAVED AND HAS BEEN SHIPPED TO ARGON MEDICAL DEVICES. AVID MEDICAL ISSUED FORMAL COMPLAINT (B)(4) TO THE MANUFACTURER ARGON MEDICAL DEVICES STATING IT WAS REPORTED DURING PROCEDURES ONE GUIDEWIRE UNRAVELED AT THE TIP AND THREE GUIDEWIRES CRIMPED ABOUT 5 INCHES DOWN THE WIRE - PART # 085210, NO LOT # IS AVAILABLE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834884 ARGON MEDICAL DEVICES GUIDEWIRE MOF ARGON MEDICAL DEVICES 085210

    Patients

    Seq Age Sex Outcome Treatment
    1