BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 7.5 FR - 40 CC

    MDR report key: 3063323 · Received April 11, 2013

    Report

    Report Number
    1219856-2013-00089
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 9, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K000729
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE OPERATION THEATRE, THE MD INSERTED THE INTRA-AORTIC BALLOON (IAB) SHEATHLESS OVER THE SPRING WIRE GUIDE (SWG) VIA THE PATIENT'S LEFT FEMORAL ARTERY. INDICATION FOR USE: SHOCK. AFTER INSERTING THE IAB INTO PLACE, THE MD COULD NOT REMOVE THE SWG FROM THE IAB. AS A RESULT, THE IAB AND SWG WERE REMOVED AS ONE UNIT. ANOTHER IAB WAS PREPPED AND INSERTED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT DEATH OR INJURY. THERE WAS A DELAY/INTERRUPTION IN INTRA-AORTIC BALLOON PUMP (IABP) THERAPY FOR THE TIMEFRAME REQUIRED TO PREP AND INSERT THE SECOND IAB SUCCESSFULLY. THERE WERE NO REPORTED PATIENT COMPLICATIONS. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. PATIENT OUTCOME IS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154669 IAB: 7.5 FR - 40 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. KF2104402

    Patients

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