BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IAB : 8 FR - 40 CC FOS

    MDR report key: 1061102 · Received June 13, 2008

    Report

    Report Number
    1219856-2008-00294
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    June 2, 2008
    Report Date
    June 13, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER TRAINING REQUEST HAS BEEN SENT TO THE SALES OFFICE FOR FOLLOW UP. FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION 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 FIBEROPTIX SENSOR (FOS) SLIDE AND CAL KEY WERE GIVEN TO CLINICIAN. CLINICIAN INSERTED CAL KEY, AUDIBLE TONE WAS HEARD AND ALL RELEVANT MESSAGES APPEARED ON PUMP SCREEN. CLINICIAN THEN INSERTED FOS SLIDE AND NO AUDIBLE TONE WAS HEARD. LIGHT BULB ICON CHANGED FROM BLACK TO BLUE AND FOLLOWING MESSAGE APPEARED ON SCREEN: AP FOS WEAK SIGNAL - SENSOR NOT FULLY CONNECTED, FOS CABLE DAMAGED OR BROKEN, CONNECTIONS ARE DIRTY, CALL FIELD SERVICE. BY THIS TIME IAB WAS INSITU AND THERE WERE NO PRESSURE WAVE OR PRESSURE READINGS VISIBLE ON SCREEN. THE FOS CODES WERE: LOW LIGHT (LL), PRESSURE LIMIT (PL), RATIOMETRIC ERROR (RE). MD ROTATED CATHETER 90 DEGREES INSIDE AORTA AND PULLED IT BACK PLUS MINUS 1CM WHILE MONITORING POSITION OF CATHETER INSIDE AORTA. THEY WERE TRYING TO SEE IF THEY COULD NOT GET A PRESSURE READING/WAVEFORM ON SCREEN, IN CASE, FOS SENSOR WAS SITTING AGAINST AORTA WALL. INNER LUMEN HAD CLOTTED UP IN INTERIM, AND WAS OCCLUDED (WHEN ASPIRATED NO BLOOD RETURNED FROM INNER LUMEN) AND PRESSURE TRANSDUCER SYSTEM COULD NOT BE USED. MD REPORTED "THERE WAS NO OTHER CHOICE BUT TO REMOVE THE IAB." AFTER REMOVING CATHETER, AND 40CC FOS IAB WAS INSERTED VIA LEFT GROIN. ALL WENT WELL, NO ALARMS OR COMPLICATIONS DURING AND AFTER THE INSERTION."

    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. MF8018726

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention INTRA-AORTIC BALLOON PUMP (BRAND UNKNOWN)