BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 40 CC FOS

    MDR report key: 1662025 · Received April 9, 2010

    Report

    Report Number
    1219856-2010-00238
    Event Type
    Malfunction
    Date Received
    April 9, 2010
    Date of Event
    March 10, 2010
    Report Date
    April 7, 2010
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED PER INSTRUCTION (PULLED NEGATIVE PRIOR TO IAB REMOVAL FROM TRAY). THE MD INSERTED THE SUPER ARROW-FLEX (SAF) SHEATH INTO THE FEMORAL ARTERY. THE IAB WAS INSERTED "ALMOST ENTIRELY" THROUGH THE SAF SHEATH WHEN RESISTANCE WAS MET. AS A RESULT, THE MD REMOVED THE IAB AND SAF SHEATH AS ONE UNIT. THE IAB WAS SHOWN TO BE FULLY OUT OF THE SAF SHEATH EXCEPT FOR APPROXIMATELY 1CM. THE IAB AND SAF SHEATH WERE DISCARDED. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND NO REPORTED SIGNIFICANT DELAY IN TREATMENT. A NEW IAB WAS INSERTED SHEATHLESS. ADDITIONAL INFORMATION RECEIVED ON 03/30/2010 FROM THE SALES REPRESENTATIVE STATED THAT THERE WAS NO EXCESSIVE BLEEDING AND THERE IS NO FURTHER INFORMATION AVAILABLE.

    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 INTERNATIONAL INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK