BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC FOS

    MDR report key: 1773479 · Received July 16, 2010

    Report

    Report Number
    1219856-2010-00469
    Event Type
    Malfunction
    Date Received
    July 16, 2010
    Date of Event
    June 20, 2010
    Report Date
    July 9, 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
    TX, US
    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 INTRA-AORTIC BALLOON (IAB) WAS PREPPED PER INSTRUCTION. THE MD INSERTED THE SUPER ARROW-FLEX (SAF) SHEATH INTO THE PT'S FEMORAL ARTERY. AS THE MD WAS INSERTING THE IAB THROUGH THE SAF SHEATH, THE IAB BECAME STUCK IN THE SAF SHEATH. THE MD REMOVED THE IAB AND THE SAF SHEATH AS ONE UNIT. ANOTHER IAB WAS PREPPED FOR INSERTION. THE SECOND IAB WAS INSERTED THROUGH A SECOND SAF SHEATH INTO THE SAME INSERTION SITE AS THE FIRST IAB ATTEMPT. THE SECOND IAB INSERTION WAS SUCCESSFUL. THERE WAS NO REPORTED OF PT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. THE DELAY IN THERAPY IS LISTED AS "JUST THE AMOUNT OF TIME IT TOOK TO EXCHANGE THE SAF SHEATH AND INSERT THE SECOND IAB." THERE WERE NO REPORTED PT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8 FR - 40 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTL., INC. MF0053008

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK