BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC

    MDR report key: 2241163 · Received August 17, 2011

    Report

    Report Number
    1219856-2011-00288
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 27, 2011
    Report Date
    August 12, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K000729
    Removal / Correction Number
    Z-0791-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE CARDIO CATH LAB THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED PER INSTRUCTION. THE MD INSERTED THE TEFLON SHEATH VIA THE PT'S LEFT FEMORAL ARTERY. WHILE INSERTING THE IAB THROUGH THE TEFLON SHEATH, THE IAB COULD NOT BE ADVANCED INTO THE CORRECT POSITION; THE IAB WAS STUCK IN THE SHEATH. AS A RESULT, THE MD REMOVED THE IAB AND THE SHEATH AS ONE UNIT. THE MD PREPPED AND INSERTED ANOTHER IAB INTO THE SAME INSERTION SITE, THE PT'S LEFT FEMORAL ARTERY. ACCORDING TO THE MD, THERE WAS NO EXCESSIVE BLEEDING. THERE WAS NO REPORTED PT DEATH OR INJURY, MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. THE IAB THERAPY WAS DELAYED/INTERRUPTED FOR 5 MINUTES UNTIL THE SECOND IAB WAS PREPPED AND INSERTED SUCCESSFULLY. THERE WERE NO REPORTED PT COMPLICATIONS. THE PT OUTCOME WAS LISTED AS "NO COMPLICATION TO PT."

    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. MF0042786

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK