BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 40 CC

    MDR report key: 1230380 · Received November 7, 2008

    Report

    Report Number
    1219856-2008-00510
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 20, 2008
    Report Date
    November 7, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K000729
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT WILL BE FILED, IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ANGIOPLASTY PROCEDURE, THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED AND THE SHEATH WAS INSERTED VIA THE LEFT FEMORAL ARTERY. THE IAB WAS SUCCESSFULLY INSERTED AND THE PUMP WAS TURNED ON. THE IAB DID NOT INFLATE SO THE MD TRIED TO MANUALLY INFLATE THE IAB WITH A SYRINGE. THE IAB DID NOT INFLATE SO THE IAB AND SHEATH WERE REMOVED AS ONE UNIT. THE MD FOUND A "SEVERE HEMATOMA ON THE PT'S ARTERY PUNCTURE SITE." THE MD REQUESTED ANOTHER IAB TO INSERT TO SUPPORT THE PT DURING THE CORONARY ANGIOPLASTY PROCEDURE. THE SECOND IAB WAS GIVEN TO THE MD. THE IAB WAS PREPPED, HOWEVER, IT WAS NOT REMOVED FROM THE TRAY. THE PT HAD HAD TWO PUNCTURES. ONE IN THE RIGHT AND ONE IN THE LEFT FEMORAL ARTERY AND THE MD DECIDED NOT TO INSERT THE SECOND IAB DUE TO THE HEMATOMA. THE PT WENT INTO THE SURGERY WITHOUT IAB SUPPORT.

    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. MF8019034

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK INTRA-AORTIC BALLOON PUMP (BRAND UNK)