BEUDAMED
    FDA Adverse Event Death Summary report: N

    IAB : 8 FR - 40 CC FOS

    MDR report key: 2023190 · Received March 16, 2011

    Report

    Report Number
    1219856-2011-00095
    Event Type
    Death
    Date Received
    March 16, 2011
    Date of Event
    March 5, 2011
    Report Date
    March 16, 2011
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    REFERENCE MDR #1219856-2011-00094 FOR THE FIRST EVENT INVOLVING THE SAME PT. IT WAS REPORTED THAT WHILE IN THE IC THORAX CENTRE, THE MD FOUND THAT THIS INTRA-AORTIC BALLOON (IAB) WAS UNABLE TO BE "ZEROED" (FIBEROTIX SENSOR FAILURE). THE DOCTOR MADE A SECOND PUNCTURE & INSERTED THE IAB, BUT THERE WAS NO ARTERIAL CURVE FROM THE TIP OF THE IAB AND NO AUGMENTATION. THEY TRIED TO USE A SECOND INTRA-AORTIC BALLOON PUMP (IABP), HOWEVER, THE RESULT WAS NO BETTER. NOTE: DURING INSERTION OF THE SECOND FOS, THE PROFESSOR, A PERFUSIONIST & STAFF NURSE OBSERVED THE CARDIOLOGIST TO MAKE SURE PROPER PROCEDURES WERE FOLLOWED. AS A RESULT, THE IAB WAS REMOVED & THE MD INSERTED A 50ML IAB (FLUID FILLED) OVER THE SPRING WIRE GUIDE (SWG). THIS IAB GAVE AN ACCEPTABLE RESULT, BUT AFTER 5 HRS, PT DEVELOPED AN ISCHEMIC LEG & THIS IAB WAS REMOVED. DUE TO THE PT'S CARDIOGENIC SHOCK, HE COULD NOT BE OPERATED ON. THE PT EXPIRED ON (B)(6) 2011. ADD'L INFO REC'D FROM THE SALES REP ON (B)(6) 2011 STATED THAT "THIS DEPARTMENT HAS USED THE ARROW IABP AND THE FIBEROPTIX FOR A LONG TIME AND ARE EXTREMELY PUNCTUAL AND EXPERIENCED WITH THE USE OF THIS TECHNIQUE AND THE ARROW PRODUCTS."

    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 INTERNATIONAL INC. KF1019036

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Death INTRA-AORTIC BALLOON PUMP