BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8FR - 40 CC

    MDR report key: 1873382 · Received September 20, 2010

    Report

    Report Number
    1219856-2010-00647
    Event Type
    Malfunction
    Date Received
    September 20, 2010
    Date of Event
    September 6, 2010
    Report Date
    September 15, 2010
    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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE CARDIO CATH LAB THE MD INSERTED THE SUPER ARROW-FLEX (SAF) SHEATH WITH DILATOR INTO THE PT'S LEFT FEMORAL ARTERY. DURING THE INTRA-AORTIC BALLOON (IAB) INSERTION, THE BALLOON STOPPED ADVANCING AND STUCK IN THE SAF SHEATH. THE MD COULD NOT PASS THE IAB THROUGH THE SAF SHEATH DUE TO CRITICAL RESISTANCE. AS A RESULT, THE MD REMOVED THE SAF SHEATH AND IAB TOGETHER AND THE MD OPENED A NEW IAB KIT (IAB-05840-U). THE MD WAS ABLE TO INSERT THE SECOND SAF SHEATH AND SECOND IAB AND FINISH THE CATHETERIZATION. THERE WAS NO EXCESSIVE BLEEDING DURING THE PROCEDURE AND THE SECOND INSERTION WAS ALSO THE PT'S LEFT FEMORAL ARTERY. THERE WAS NO REPORTED PT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. THE DELAY IN THERAPY WAS LISTED AS 10 MINUTES. THE PT OUTCOME IS "THE PT DOES NOT HAVE ANY COMPLICATIONS AND IS FINE." ADDITIONAL INFO RECEIVED FROM THE DISTRIBUTOR ON 9/9/2010 STATED THAT "THE MD PREPARED THE IAB CATHETER ACCORDING TO THE INSTRUCTIONS FOR USE, FOLLOWING ONE-WAY VALVE ATTACHMENT, VACUUMING THE BALLOON INSIDE OF THE TRAY AND REMOVING THE BALLOON FROM THE TRAY JUST BEFORE INSERTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8FR - 40 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. MF0042501

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK