BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8FR - 40 CC FOS

    MDR report key: 1647041 · Received March 26, 2010

    Report

    Report Number
    1219856-2010-00192
    Event Type
    Malfunction
    Date Received
    March 26, 2010
    Date of Event
    March 2, 2010
    Report Date
    March 26, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    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 CATH LAB, THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED AND THE MD INSERTED THE SUPER ARROW-FLEX (SAF) SHEATH INTO THE FEMORAL ARTERY. THE IAB WAS THREADED OVER THE SPRING WIRE GUIDE (SWG) AND INTO THE SAF SHEATH; HOWEVER, THE IAB COULD NOT BE ADVANCED TOTALLY THROUGH THE SAF SHEATH. AS A RESULT, THE MD REMOVED THE IAB AND SAF SHEATH AS ONE UNIT. ANOTHER IAB-05840-LWS WAS OPENED AND USED WITHOUT COMPLICATIONS. THE MD USED THE SAME INSERTION SITE AND SWG AND HE WAS ABLE TO INSERT THE SECOND IAB THROUGH THE SECOND SAF SHEATH. THERE WAS NO REPORTED EXCESSIVE BLEEDING. THERE WERE NO REPORTED PT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB : 8FR - 40 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK