BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC FOS

    MDR report key: 1934630 · Received November 24, 2010

    Report

    Report Number
    1219856-2010-00863
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 23, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE CATH LAB THE BALLOON BEGAN TO UNRAVEL WHEN THEY WERE INSERTING IT IN A 9FR SHEATH NOT FROM THE ARROW KIT. THE STAFF REPORTED THAT THE ONE-WAY VALVE WAS REMOVED PRIOR THE COMPLETE INSERTION. A SECOND BALLOON WAS INSERTED WITH NO PROBLEMS. THEY WERE NOT COMPLICATIONS NOTED AND THE PT REMAINS IN THE ICU WITH INTRA-AORTIC BALLOON PUMP (IABP) THERAPY. ADDITIONAL INFO RECEIVED ON (B)(6) 2010 FROM THE SALES REP STATED "I WAS THERE LAST NIGHT RIGHT AFTER THE OCCURRENCE, I MET WITH THE DOCTOR, IT APPEARS THAT THE ONE-WAY VALVE WAS REMOVED PRIOR TO INSERTION WHICH CAUSED THE STUCK IN SHEATH SITUATION. I WAS ALSO ABLE TO FOLLOW THE PT INTO THE ICU WHERE HE WAS ON PUMP DOING WELL AS CAN BE EXPECTED. NO COMPLICATIONS RESULTING FROM THE IAB OR PUMP." F/U INFO FROM THE SALES REP ON (B)(6) 2010 REPORTED THAT "THE PT IS OFF THE IABP SINCE SUNDAY WITH NO PROBLEMS TO REPORT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8 FR - 40 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTL., INC. KF0098039

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK