BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR 40 CC

    MDR report key: 1000663 · Received February 15, 2008

    Report

    Report Number
    1219856-2008-00047
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    February 1, 2008
    Report Date
    February 15, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K970689
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN 2008, THE MD INSERTED THE INTRA-AORTIC BALLOON (IAB) FOR SUPPORT DURING A LONG SURGICAL PROCEDURE. AFTER THE SURGERY THE PT WAS TAKEN TO THE RECOVERY ROOM AND ON TO CARDIAC CARE UNIT WITH AN OPEN CHEST. THE FOLLOWING MONTH, THE PT WAS TAKEN BACK TO THE OPERATING ROOM AND THE STERNUM WAS CLOSED. THE NEXT DAY, THE MD MET GREAT DIFFICULTY REMOVING THE IAB FROM THE PT. ONCE THE IAB WAS REMOVED THERE WAS RED/BROWN SAND LIKE MATERIAL BUNCHED UP INSIDE THE DISTAL END OF THE IAB. THE SURGEON HAD TO REPAIR THE INSERTION SITE AS WELL AS A THROMBUS REMOVAL IN "POPLITEAL ARTERY" WAS REQUIRED. IT WAS REPORTED THAT THE PUMP DID NOT ALARM DURING THE IAB THERAPY. PUMP STRIPS WERE NOT GENERATED. THE PT IS RECOVERING NICELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8 FR 40 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention AUTOCAT 2 WAVE BALLOON PUMP