BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8F BGC 95CM

    MDR report key: 2968107 · Received February 19, 2013

    Report

    Report Number
    0002954917-2013-00015
    Event Type
    Malfunction
    Date Received
    February 19, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 31, 2013
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    DQY
    PMA / PMN Number
    K102657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INITIAL PREPARATION USING CONTRAST SOLUTION, THE BALLOON WAS NOT INFLATED. WHILE THE BALLOON WAS PURGED, AIR BUBBLES NOTED COMING FROM THE BALLOON. THE PHYSICIAN SUSPECTED THAT THERE APPEARED TO BE A HOLE OR PERFORATION IN THE BALLOON LUMEN. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71888 8F BGC 95CM CATHETER, PERCUTANEOUS DQY CONCENTRIC MEDICAL 35777

    Patients

    Seq Age Sex Outcome Treatment
    1