BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENSATION 7, 5 FR. 34CC IAB

    MDR report key: 3946382 · Received July 7, 2014

    Report

    Report Number
    2248146-2014-00169
    Event Type
    Death
    Date Received
    July 7, 2014
    Date of Event
    July 6, 2011
    Report Date
    July 14, 2011
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    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 AND BETWEEN THE CATHETER AND THE SHEATH. ONE KINK WAS FOUND ON THE CATHETER TUBING NEAR THE Y-FITTING APPROX 76.5CM FROM THE IAB TIP. PRODUCT EVAL: AN UNDERWATER LEAK TEST OF THE BALLOON, CATHETER, Y-FITTING AND EXTRACORPOREAL TUBING WAS PERFORMED AND ONE LEAK WAS DETECTED ON THE MEMBRANE APPROX 1.3CM FROM THE REAR SEAL MEASURING 0.025CM 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 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 IN CATHETER TUBING. DATASHEET CHECKED "NO" WHEN ASKED IF ANY ADVERSE EVENTS WERE RELATED TO THE EVENT. PT IS LISTED AS DECEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394677 SENSATION 7, 5 FR. 34CC IAB INTRA-AORTIC BALLOON DSP DATASCOPE CORP. 0684-00-0474 2458

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death