BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC FOS

    MDR report key: 1022874 · Received March 28, 2008

    Report

    Report Number
    1219856-2008-00158
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    October 8, 2007
    Report Date
    March 28, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER EVALUATION, IT WAS DETERMINED THAT THE EVENT WAS MDR REPORTABLE. EVALUATION: THE INTRA-AORTIC BALLOON (IAB) WAS RETURNED. PUMP TUBING, GUIDEWIRES, AND SHEATH WERE NOT RETURNED. THERE WAS BLOOD ON THE EXTERIOR SURFACE OF THE IAB. THE ONE-WAY VALVE WAS ATTACHED ON THE LOCK CONNECTOR. THE DATA KEY AND SLIDE CONNECTED WERE ATTACHED TO THE FIBER OPTIX SENSOR (FOS) CABLE. A DIFFERENT GUIDEWIRE WAS FED THRU THE CENTRAL LUMEN WITH SOME RESISTANCE. A VACUUM WAS PULLED ON THE IAB AND HELD. THE FOS WAS LIGHT LEVEL AND PASSED. THE IAB WAS SUBMERGED AND PRESSURIZED IN WATER. NO LEAKS WERE DETECTED IN THE IAB OR BLADDER. BLADDER WAS MEASURED AND WITHIN SPECIFICATION. A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON THE IAB AND IT MET ALL SPECIFICATIONS AND PASSED ALL IN-PROCESS TESTING. NO PROBLEM WAS FOUND WITH THE IAB. DUE TO THE FACT THAT THE INVOLVED SHEATH WAS NOT RETURNED, THE ROOT CAUSE COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MD INSERTED THE SHEATH AND THE CLINICIAN PREPPED THE IAB PER INSTRUCTION. THE MD COULD NOT ADVANCE THE IAB THROUGH THE SHEATH. AS A RESULT, ANOTHER IAB WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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. MF7076013

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK