BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 30 CC FOS

    MDR report key: 2538096 · Received April 9, 2012

    Report

    Report Number
    1219856-2012-00131
    Event Type
    Malfunction
    Date Received
    April 9, 2012
    Date of Event
    March 22, 2012
    Report Date
    April 9, 2012
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    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 CATH LAB THE MD INSERTED THE SHEATH OVER THE SPRING WIRE GUIDE INTO THE PT'S RIGHT FEMORAL ARTERY. AS THE MD TRIED TO FEED THE INTRA-AORTIC BALLOON (IAB) OVER THE SWG INTO THE SHEATH, THE IAB BECAME STUCK. THE MD USED THE SECOND SWG IN THE PACK AND THE SAME SITUATION OCCURRED. AS A RESULT, THE MD REQUESTED ANOTHER ARROW IAB FOR INSERTION. THE MD INSERTED THE SECOND IAB OVER THE EXISTING SWG AND THROUGH THE SHEATH WITHOUT DIFFICULTIES. THERE WAS NO REPORTED PT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. THE IAB THERAPY WAS DELAYED/INTERRUPTED FOR ABOUT THREE MINUTES. THERE WERE NO REPORTED PT COMPLICATIONS AND THE PT WAS TRANSFERRED TO ANOTHER FACILITY TO HAVE A CABG (CORONARY ARTERY BYPASS GRAFT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB : 8 FR - 30 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTL., INC. KF1039462

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR