BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEGA 7.5FR. 40CC IAB

    MDR report key: 3954537 · Received July 17, 2014

    Report

    Report Number
    2248146-2014-00276
    Event Type
    Death
    Date Received
    July 17, 2014
    Date of Event
    March 11, 2013
    Report Date
    March 12, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCTION CONDITION REC'D: 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. 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 0.013CM IN LENGTH. CONCLUSION: THE REPORTED ALARM WAS MOST LIKELY TRIGGERED BY A LEAK WHICH WAS FOUND ON THE MEMBRANE. 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

    PATIENT ON IABP IN OUR CCU ON (B)(6) 2013 ALARMED "BLOOD DETECTED" CATHETER REMOVED WITHIN 30 MINUTES, VISIBLE PARTICLES IN BALLOON CATHETER. NO DIFFICULTIES ENCOUNTERED DURING INSERTION AND PUMPING. ALARM SOUNDED - "BLOOD DETECTED". UPDATED: THE DEATH WAS NOT PRODUCT RELATED. THERE WAS BLOOD IN THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420221 MEGA 7.5FR. 40CC IAB INTRA-AORTIC BALLOON DSP DATASCOPE CORP. 0684-00-0293 2773

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death