BEUDAMED
    FDA Adverse Event Death Summary report: N

    LINEAR 7.5FR. 34CC IAB

    MDR report key: 3946229 · Received July 2, 2014

    Report

    Report Number
    2248146-2014-00189
    Event Type
    Death
    Date Received
    July 2, 2014
    Date of Event
    December 23, 2011
    Report Date
    March 7, 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 RECEIVED: THE PRODUCT WAS RETURNED WITH THE MEMBRANE COMPLETELY UNFOLDED AND BLOOD ON THE INTERIOR AND EXTERIOR OF THE CATHETER. ONE KINK WAS FOUND ON THE CATHETER TUBING NEAR THE Y-FITTING APPROXIMATELY 75.9CM FROM THE IAB TIP. PRODUCT EVALUATION: AN UNDERWATER LEAK TEST OF THE BALLOON, CATHETER, Y-FITTING AND EXTRACORPOREAL TUBING WAS PERFORMED AND ONE LEAK WAS DETECTED ON THE MEMBRANE APPROXIMATELY 1.8CM FROM THE REAR SEAL MEASURING 0.038CM IN LENGTH. CONCLUSION: UNDER MAGNIFICATION, A WHITISH PATCH WAS OBSERVED AROUND THE LEAK. THIS WHITISH PATCH IS THE TYPICAL APPEARANCE OF AN ABRASION MARK WHICH IS CAUSED BY CALCIFIED PLAQUE IN THE AORTA. THE MEMBRANE PENETRATION LOCATED WITHIN AN ABRASION MARK IS TYPICAL OF THAT PRODUCED BY CONTACT WITH CALCIFIED PLAQUE DURING COUNTERPULSATION THERAPY. A REVIEW OF THE DEVICE HISTORY DOES NOT INDICATE ANY LOT SPECIFIC ISSUES. (B)(4).

    Description of Event or Problem · 1

    BLOOD INTO THE HELIUM TUBESLAUCH. PRESSURE ALARM. DRUCKALARM FILLPRESSURE. INDICATION: CARDIAC DEGENERATION. NOTE: PATIENT DECEASED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385329 LINEAR 7.5FR. 34CC IAB INTRA-AORTIC BALLOON DSP DATASCOPE CORP. 0684-00-0474 2527

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death