BEUDAMED
    FDA Adverse Event Death Summary report: N

    IAAB : 8 FR - 40 CC

    MDR report key: 2792393 · Received October 11, 2012

    Report

    Report Number
    1219856-2012-00301
    Event Type
    Death
    Date Received
    October 11, 2012
    Date of Event
    September 18, 2012
    Report Date
    October 9, 2012
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K981660
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    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 WAS REPORTED THAT WHILE IN THE CATH LAB, THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED AND INSERTED VIA A SHEATH AND THROUGH THE PT'S FEMORAL ARTERY. LESS THAN ON MINUTE LATER, IT WAS NOTED THAT AFTER INSERTION BLOOD WAS FOUND SEEPING INTO THE HELIUM PATHWAY AND THE MEMBRANE DID NOT INFLATE. THE IAB WAS REMOVED. PER THE MD, THE "ISSUE WAS NOT RESOLVED" AND THE PT EXPIRED 6 HOURS LATER. THE MD STATED THAT CARDIOGENIC SHOCK AND THE NONFUNCTIONING INTRA-AORTIC BALLOON PUMP (IABP) THERAPY DID CONTRIBUTE TO THE DEATH OF THIS PT. ADDITIONAL INFO RECEIVED FROM THE TELEFLEX (B)(4) SALES REP ON (B)(4) 2012 STATED THE IAB WAS PREPPED PER THE INSTRUCTIONS FOR USE. THE PT DID NOT HAVE TORTUOUS VESSELS. THE IAB WAS INSERTED THROUGH THE SHEATH AND EXITED THE SHEATH FULLY WHEN INSERTED. THE PUMP ALARMED. THE MD FOUND BLOOD IN THE HELIUM TUBING AND THERE WAS NO AUGMENTATION. THE IAB WAS REMOVED FROM THE PT AND ANOTHER IAB WAS NOT INSERTED BECAUSE THE PT COLLAPSED AND WENT INTO RESPIRATORY ARREST AND WAS PUT ON A VENTILATOR. FURTHER INFO RECEIVED ON (B)(4) 2012 FROM THE SALES REP REPORTED THAT "SINCE THEY HAD THE COMPLICATION IN THE FIRST INSERTION OF BALLOON THEY NEVER TAKE CHANCE AGAIN FOR THE INSERTION OF ANOTHER BALLOON AND ALSO THE PT WAS NOT AFFORDABLE UP TO THAT EXTENT, SO THE DOCTOR DECIDED TO MANAGE WITHOUT IABP THERAPY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAAB : 8 FR - 40 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. KF1101706

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death DOPAMINE (400MG)| ISOPRENALINE| NORADRENALINE