BEUDAMED
    FDA Adverse Event Death Summary report: N

    IAB : 8 FR - 40 CC FOS

    MDR report key: 1599353 · Received February 5, 2010

    Report

    Report Number
    1219856-2010-00071
    Event Type
    Death
    Date Received
    February 5, 2010
    Date of Event
    April 26, 2009
    Report Date
    February 5, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). EVALUATION: AN IAB, SUPER ARROW FLEX (SAF) SHEATH, AND DRIVELINE TUBING WERE RETURNED FOR EVALUATION. TRACES OF BLOOD WERE OBSERVED ON THE IAB. THE SAF SHEATH WAS ON THE BLADDER WITH 12.7 CM OF THE BLADDER HAVING EXITED THE HUB END OF THE SHEATH. THE IFU STATES: "DO NOT REMOVE ARROW IAB THROUGH HEMOSTASIS SHEATH INTRODUCER OR HEMOSTASIS DEVICE. ONCE UNWRAPPED (UNFURLED), BALLOON PROFILE WILL NOT ALLOW PASSAGE THROUGH THE SHEATH AND ATTEMPTED REMOVAL IN THIS MANNER MAY RESULT IN ARTERIAL TEARING, DISSECTION OR BALLOON DAMAGE". THERE WERE MAJOR BENDS IN THE CENTRAL LUMEN AT 3CM, 25.5CM AND 32CM PROXIMAL TO THE BLADDER. THERE WERE MINOR BENDS IN CENTRAL LUMEN IN BETWEEN THE MAJOR BENDS. THE CENTRAL LUMEN WAS BENT AND THE CATHETER WAS KINKED 5MM ABOVE THE BIFURCATE. THE CATHETER WAS CRUMPLED FROM 9CM TO 14CM PROXIMAL TO THE BLADDER. AN IN-HOUSE GUIDEWIRE WAS FED THROUGH THE LUER END OF THE CENTRAL LUMEN BUT WOULD NOT PASS THE BENT 5MM ABOVE THE BIFURCATE. THE CENTRAL LUMEN COULD NOT BE FLUSHED OR ASPIRATED. THE FOS CONNECTOR AND CAL KEY WERE CONNECTED TO THE FOS CABLE WHICH WAS CONNECTED TO THE IAB. THE FOS CENTER POST WAS RECESSED WITHIN THE CONNECTOR HOUSING. REFERENCE: FIBEROPTIX AP SENSOR ZEROING AND CALIBRATION GUIDE. "NOTE: IF RESISTANCE IS MET DURING CONNECTION, DO NOT FORCE THE CONNECTION. PULL SLIDE CONNECTOR BACK SLIGHTLY AND REATTEMPT THE CONNECTION". THE RETAINING CLIPS WERE INTACT. THE CENTER POST SURFACE WAS CLEAN. THE CENTER POST WAS RESEATED IN THE HOUSING. THE FOS WAS LIGHT LEVEL TESTED AND FAILED WITH AN INDICATION OF BROKEN FIBER. WHEN THE FOS WAS DISCONNECTED FROM THE TESTER, THE CENTER POST WAS STILL CORRECTLY SEATED. THE CAL KEY WAS TESTED WITH A GOOD SENSOR AND PASSED. THE FOS WAS CONNECTED TO IABP: THE CONNECTOR CLICKED INTO PLACE EASILY, THE CENTER POST DID NOT RECESS, BUT THE IABP DID NOT RECOGNIZE THE FOS DUE TO THE BROKEN FIBER. AFTER ALL MEANS OF EXTRACTING THE IAB FROM THE SHEATH WITHOUT DAMAGE HAD BEEN EXHAUSTED, THE SHEATH WAS CUT DOWN 9CM FORM THE TIP TO CUT BELOW WHERE THE BULK OF MATERIAL WAS FELT. THE IAB WAS CUT THROUGH 5CM FROM THE DISTAL TIP. THE PROXIMAL END OF THE IAB WAS EASILY EXTRACTED FROM THE REMAINDER OF THE SHEATH. THE FOS FIBER WAS INTACT IN THIS SECTION OF THE IAB. THE REMAINDER OF FOS FIBER WAS EASILY EXTRACTED FROM THE PORTION OF THE IAB STILL IN THE SHEATH. IT WAS NECESSARY TO UNRAVEL THE SHEATH TO EXTRACT THE REMAINDER OF THE IAB. IT COULD BE SEEN THAT THE BLADDER WAS FOLDED OVER THE TIP OF THE IAB. THE FOS FIBER WAS BROKEN 1.4CM FROM THE DISTAL TIP. BECAUSE THE BLADDER HAD BEEN PULLED BACK INTO THE SHEATH WHEN THE IAB WAS REMOVED, IT IS POSSIBLE THAT THE BREAK OCCURRED AT THAT TIME. THE AMOUNT OF GLUE AT THE TACK POINT TO THE TIP WAS SUFFICIENT. WHEN THE FIBER OPTIC PRESSURE SIGNAL (FOS) IS NOT AVAILABLE, THE IAB IS STILL ABLE TO BE USED SINCE AN AP (ARTERIAL PRESSURE) SIGNAL IS AVAILABLE THROUGH THE CENTRAL LUMEN. A TRANSDUCER CAN BE CONNECTED TO THE CENTRAL LUMEN, AS IN ALL IABS, AND THE ARTERIAL PRESSURE AND TIMING CAN BE MONITORED FROM THIS LOCATION. THE EFFECT OF NOT HAVING AN AP FOS SIGNAL IS THAT THE ENHANCED WAVE INFLATION TIMING ALGORITHM IS NOT AVAILABLE IN AUTOPILOT MODE. THE REPORTED COMPLAINT WAS CONFIRMED, AS THE FOS WAS RECESSED IN ITS HOUSING DUE TO EXCESSIVE FORCE APPLIED ON CONNECTION TO THE IABP. WHEN THE FOS IS NOT CORRECTLY CONNECTED TO THE IABP, THE LIGHT PATH CANNOT BE ESTABLISHED AND THE FOS WILL NOT BE RECOGNIZED BY THE IABP. IT IS UNLIKELY THAT THE IAB WAS A CAUSAL OR CONTRIBUTING FACTOR TO THE DEATH OF THE PT. THE REPORTING HEALTHCARE PROFESSIONAL SAID, "THERE IS A CLEAR STATEMENT THAT THE DEATH OF THE PT WAS NOT A RESULT OF THE USE OF THE FOS CATHETER". WE ARE SUBMITTING THIS REPORT BECAUSE WE HAVE DETERMINED THAT ON THE INFO AVAILABLE, WE CANNOT CONCLUDE WITH CERTAINTY THAT THE DEVICE WAS NOT A CONTRIBUTING FACTOR".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE CARDIOLOGY, THE DOCTOR INSERTED THE SHEATH VIA THE FEMORAL ARTERY. THE INTRA-AORTIC BALLOON (IAB) WAS BEING INSERTED DURING "CARDIOGENIC SHOCK AND RESUSCITATION MEASURES". THE FIBEROPTIX SENSOR (FOS) WAS NOT DETECTED BY THE INTRA-AORTIC BALLOON PUMP (IAP-0500D (B) (4)). ACCORDING TO THE DOCTOR, ALL RESUSCITATION MEASURES WERE STOPPED AND THE FOS IAB WAS NOT USED AS A CONVENTIONAL CATHETER BECAUSE THE PT HAD ALREADY DIED. THE LENGTH OF TIME IN USE PRIOR TO THE EVENT WAS ONE MINUTE. PER THE DOCTOR "THERE IS A CLEAR STATEMENT THAT THE DEATH OF THE PT WAS NOT A RESULT OF THE USE OF THE FOS CATHETER".

    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. MF8050995

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death CATOCHOLAMINES