BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 40 CC FOS

    MDR report key: 2844331 · Received November 8, 2012

    Report

    Report Number
    1219856-2012-00324
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Date of Event
    October 15, 2012
    Report Date
    November 5, 2012
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WS REPORTED THAT WHILE IN THE CATH LAB, THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED AND ZEROED SUCCESSFULLY PRIOR TO INSERTION. THE MD INSERTED THE SHEATH VIA THE PATIENT'S RIGHT FEMORAL ARTERY. AFTER THE IAB WAS INSERTED, THE MD WAS UNABLE TO GET PRESSURES ON THE PUMP AND AS A RESULT, THE MD REMOVED THE IAB BY PULLING IT BACK THROUGH THE SHEATH. THE LIGHT BULB ICON ON THE CONSOLE WAS GREEN. ANOTHER IAB WAS PREPPED AND INSERTED THROUGH THE EXISTING SHEATH IN THE PT'S RIGHT FEMORAL ARTERY. THERE WAS NO REPORTED PT DEATH OR INJURY. THERE WERE NO REPORTED PT COMPLICATIONS. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. THERE WAS NO REPORTED DELAY OR INTERRUPTION IN INTRA-AORTIC BALLOON PUMP (IABP) THERAPY. ADDITIONAL INFO RECEIVED ON (B)(6) 2012 BY THE MANAGER, CLINICAL SUPPORT, STATED THAT THE MEMBRANE OF THE IAB DID NOT APPEAR TO HAVE BEEN INFLATED PRIOR TO THE MD REMOVING BACK OUT OF THE SHEATH. UPDATED INFO RECEIVED ON (B)(6) 2012 REPORTED THAT "THE PT HAD PROCEDURE AND WAS DOING WELL IN ICU." FURTHER INFO RECEIVED (B)(6) 2012 FROM THE MANAGER, CLINICAL SUPPORT, STATED THAT THE ZERO PROCESS FOR THE FIBEROPTIX SENSOR (FOS) TOOK PLACE AS RECOMMENDED AND THE LIGHT INDICATED ZERO AND CALIBRATION SUCCESSFUL PRIOR TO INSERTION. ONCE THE IAB WAS IN THE AORTA, THEY WERE NOT ABLE TO GET ANY PRESSURE READINGS AND THEREFORE REMOVED THE IAB WITHOUT ESTABLISHING A FLUID FILLED SETUP AS AN ALTERNATIVE PRESSURE READING. THE IAB WAS REMOVED FROM THE PT BECAUSE THERE WAS NO PRESSURE READING FROM THE FOS AND THE MD WANTED TO USE THE FOS.

    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. KF2043014

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK INTRA-AORTIC BALLOON PUMP