BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC FOS

    MDR report key: 1899916 · Received October 22, 2010

    Report

    Report Number
    1219856-2010-00751
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 21, 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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 AND THE SUPER ARROW-FLEX (SAF) SHEATH WAS INSERTED INTO THE PT'S "RIGHT GROIN". THE MD FOUND IT IMPOSSIBLE TO INSERT THE IAB THROUGH THE SAF SHEATH AND AS A RESULT, THE IAB AND SAF SHEATH WERE REMOVED AS ONE UNIT. THE MD WAS ABLE TO REMOVE THE IAB FROM THE SAF SHEATH AFTER IT WAS REMOVED FROM THE PT. THE MD REQUESTED ANOTHER SAF SHEATH FOR THE PROCEDURE. A SECOND IAB KIT WAS OPENED AND THE SAF SHEATH WAS THREADED OVER THE SPRING WIRE GUIDE (SWG) AND INTO THE PT'S RIGHT GROIN. USING THE SAME IAB, THE MD WAS ABLE TO INSERT THE IAB THROUGH THE SAF SHEATH AND INTO THE PT SUCCESSFULLY. THERE WAS NO REPORTED PT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. THE DELAY IN IAB THERAPY WAS "A FEW MINUTES, UNTIL THE SECOND SAF SHEATH WAS RETRIEVED FROM A NEW IAB TRAY AND INSERTED." THE PT'S OUTCOME IS LISTED AS "FINE".

    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. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK