BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8F BGC 95CM

    MDR report key: 2933901 · Received January 29, 2013

    Report

    Report Number
    0002954917-2013-00011
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 14, 2013
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    DQY
    PMA / PMN Number
    K102657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING "TRACKING THE BALLOON IN PLACE", IT WAS NOTED THAT THE BALLOON WAS RUPTURED. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38806 8F BGC 95CM CATHETER, PERCUTANEOUS DQY CONCENTRIC MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1