BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 40 CC

    MDR report key: 1230386 · Received November 7, 2008

    Report

    Report Number
    1219856-2008-00502
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 14, 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 WHILE IN THE CATH LAB THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED PER INSTRUCTION. THE SHEATH WAS INSERTED VIA THE LEFT FEMORAL ARTERY. AS THE MD WAS INSERTING THE IAB INTO THE SHEATH, THE MEMBRANE BEGAN TO UNWRAP. THE MD REMOVED THE IAB FROM THE SHEATH AND USED A SECOND IAB THROUGH THE SAME SHEATH TO PLACE THE IAB. THE IAB WAS INSERTED WITHOUT COMPLICATIONS. IT WAS NOTED THAT THE SALES REP STATED THAT SHE DID TRAIN THE HOSPITAL STAFF TO REMOVE THE IAB AND THE SHEATH AS ONE UNIT.

    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. MF8029433

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK