BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR-40 CC FOS

    MDR report key: 1881845 · Received October 8, 2010

    Report

    Report Number
    1219856-2010-00721
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 5, 2010
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    FOS
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVALUATION.

    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 SHEATH INTO THE PATIENT'S FEMORAL ARTERY. UPON INSERTION OF THE IAB THROUGH THE SHEATH, THE IAB BECAME STUCK IN THE MIDDLE OF THE SHEATH. AS A RESULT, THE IAB AND THE SHEATH WERE REMOVED. USING THE SAME INSERTION SITE THE MD INSERTED ANOTHER SHEATH AND IAB WITH SUCCESS. THERE WAS NO REPORTED PATIENT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. THE INTERRUPTION IN IAB THERAPY WAS LISTED AS 3 TO 5 MINUTES. THE PATIENT OUTCOME IS LISTED AS THE PATIENT "WENT TO THE UNIT."

    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) FOS ARROW INTERNATIONAL INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR