BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 40 CC FOS

    MDR report key: 1023647 · Received April 1, 2008

    Report

    Report Number
    1219856-2008-00163
    Event Type
    Malfunction
    Date Received
    April 1, 2008
    Date of Event
    March 11, 2008
    Report Date
    April 1, 2008
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED PER INSTRUCTION AND CONNECTED TO THE PUMP (AUTOCAT2 WAVE). THE FIBER OPTIX SENSOR WAS CONNECTED TO THE PUMP; AUTOMATIC ZEROING WAS NOT POSSIBLE. THE MD PERFORMED A SHEATHLESS INSERTION AND WHILE INSERTING THE IAB IT BECAME KINKED, THE IAB WAS REMOVED AND THE MD REQUESTED ANOTHER ARROW IAB FOR INSERTION. SEE MEDWATCH 1219856-2008-00164 FOR SECOND EVENT INVOLVING THE SAME PT.

    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 INTERNATIONAL INC NA

    Patients

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