BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO INTRODUCER SHEATH SET

    MDR report key: 2030808 · Received March 22, 2011

    Report

    Report Number
    1625425-2011-00034
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Report Date
    March 22, 2011
    Manufacturer
    ARGON MEDICAL DEVICES, INC.
    Product Code
    DRE
    PMA / PMN Number
    K780126
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF INVESTIGATION WILL BE FILED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTS 3CM OF THE WIRE BROKE OFF INSIDE OF PT. THIS PORTION OF THE WIRE IS STILL IN THE PT. DOCTOR IS MONITORING THE PT TO SEE WHICH STEPS TO TAKE NEXT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO INTRODUCER SHEATH SET DRE ARGON MEDICAL DEVICES, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other