BEUDAMED
    FDA Adverse Event Death Summary report: N

    LINEAR 7.5FR. 40CC IAB

    MDR report key: 3977044 · Received July 24, 2014

    Report

    Report Number
    2248146-2014-00236
    Event Type
    Death
    Date Received
    July 24, 2014
    Date of Event
    June 12, 2012
    Report Date
    July 10, 2012
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT CONDITION REC'D: THE PRODUCT WAS RETURNED WITH THE MEMBRANE COMPLETELY UNFOLDED AND BLOOD FOUND ON THE EXTERIOR OF THE CATHETER. TWO KINKS WERE FOUND, ONE ON THE INNER LUMEN APPROXIMATELY 5.8CM FROM THE IAB TIP AND THE OTHER ON THE CATHETER TUBING 71.9CM FRO THE IAB TIP. PRODUCT EVALUATION: AN UNDERWATER LEAK TEST OF THE BALLOON, CATHETER, Y-FITTING AND EXTRACORPOREAL TUBING WAS PERFORMED AND NO LEAKS WERE DETECTED. THE IAB WAS PLACED ON THE CS300 PU,P AND PUMPED FOR TWO HOURS WHICH REPRESENTS ONE COMPLETE AUTOFILL CYCLE. THE IAB PUMPED NORMALLY AND NO ALARM SOUNDED FROM THE PUMP. CONCLUSION: THE REPORTED PROBLEM COULD NOT BE DUPLICATED DURING TESTING. WE ARE UNABLE TO DETERMINE WHEN THE KINKS OCCURRED, HOWEVER IF THE KINKS OCCURRED DURING THE PROCEDURE IT COULD RESTRICT THE GAS FLOW THROUGH THE IAB WHICH COULD CAUSE THE REPORTED ALARM. A REVIEW OF THE DEVICE HISTORY DOES NOT INDICATE ANY LOT SPECIFIC ISSUES. (B)(4).

    Description of Event or Problem · 1

    DATASHEET REPORTED: "OCCURING GAS ALERT, IN CONTEMPT OF INCONSPICUOUS CONNECTION CATHETER LEAKY?" NO SECOND IAB INSERTED "NO HEMODYNAMIC FINDINGS WITH IABP, PATIENT PREFINAL". PATIENT DIED ON (B)(6) 2012 NOT ATTRIBUTED TO IAB EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433586 LINEAR 7.5FR. 40CC IAB INTRA-AORTIC BALLOON DSP DATASCOPE CORP. 0684-00-0475 2708

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death