BEUDAMED
    FDA Adverse Event Death Summary report: N

    IAB: 8 FR - 40 CC

    MDR report key: 3251904 · Received July 25, 2013

    Report

    Report Number
    1219856-2013-00183
    Event Type
    Death
    Date Received
    July 25, 2013
    Date of Event
    June 22, 2013
    Report Date
    July 8, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K993966
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT INVOLVED A FEMALE PT THAT EXPIRED WHILE IN THE CLINIC OF ANESTHESIOLOGY AND INTENSIVE CARE UNIT/POSTOPERATIVE DEPT DURING USE. THE DOCTOR INSERTED AN IAB-04840-U (SERIAL NUMBER (B)(4)/LOT NUMBER KF2094254) THROUGH THE SHEATH VIA LEFT FEMORAL ARTERY WITHOUT ISSUE ON (B)(6) 2013 AT 2000 HOURS. AT 5 AM (0500) ON (B)(6) 2013, INFORMATION FROM THE NURSES WAS RECEIVED STATING THAT THE INTRA-AORTIC BALLOON PUMP (IABP) ALERTED FOR "KINKING OR RUPTURE" OF THE IAB AND "BLOOD IN THE LINE." AS A RESULT, THE IABP THERAPY WAS STOPPED APPROX 9 HOURS AFTER INITIATED AND THE DECISION WAS MADE TO REMOVE THE IAB. AS A RESULT, WHILE THE MD WAS ATTEMPTING TO REMOVE THE IAB THROUGH THE SHEATH, DIFFICULTY WAS MET; THE IAB APPEARED TO BE TRAPPED. THEY WERE EVENTUALLY ABLE TO REMOVE THE IAB WITH THE SHEATH SUCCESSFULLY. THE DOCTOR INSERTED A NEW INTRA-AORTIC BALLOON (IAB) THROUGH THE SHEATH VIA RIGHT FEMORAL ARTERY (NEW INSERTION SITE) SUCCESSFULLY AND THE IABP THERAPY WAS ABLE TO CONTINUE AS PLANNED UNTIL THE PT EXPIRED. THERE WAS A 30 MINUTE DELAY OR INTERRUPTION IN THERAPY NOTED WHICH CAUSED HARM TO THE PT. IT IS DIFFICULT TO ESTIMATE THE CONSEQUENCES FOR THE PT. THE PT HAD BEEN IN SHOCK DURING THE IABP THERAPY AND THE IAB REPLACEMENT DIDN'T HELP THE CAUSE. IN SPITE OF THE ADDITIONAL TREATMENT FOR THE PT, THE PT EXPIRED AT 12 OF THE EVENT ((B)(6) 2013). THERE WERE NO PUMP STRIPS GENERATED. AN X-RAY WAS PERFORMED AFTER THE SECOND IAB INSERTION; THE SECOND IAB WAS OBSERVED TO BE IN TO CORRECT POSITION AND THE X-RAY IS AVAILABLE FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348119 IAB: 8 FR - 40 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death| O INTRA-AORTIC BALLOON PUMP