BEUDAMED
    FDA Adverse Event Death Summary report: N

    LINEAR 7.5 FR 40CC IAB

    MDR report key: 3946234 · Received July 2, 2014

    Report

    Report Number
    2248146-2014-00123
    Event Type
    Death
    Date Received
    July 2, 2014
    Date of Event
    May 9, 2011
    Report Date
    August 12, 2011
    Manufacturer
    DATASCOPE CORP.,
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    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. AN UNDERWATER LEAK TEST OF THE BALLOON, CATHETER, Y-FITTING AND EXTRACORPOREAL TUBING WAS PERFORMED AND ONE LEAK WA DETECTED ON THE MEMBRANE APPROXIMATELY 1.3CM FROM THE REAR SEAL MEASURING 0.051CM IN LENGTH. CONCLUSION: UNDER THE 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. AN ABRASION LEAK IS A COMMON FAILURE MODE CAUSED BY CALCIFIED PLAQUE IN THE AORTA. A REVIEW OF THE DEVICE HISTORY DOES NOT INDICATE ANY LOT SPECIFICATION ISSUES. (B)(4).

    Description of Event or Problem · 1

    PT HAS IAB CATHETER IN HER LEFT FEMORAL ARTERY. SITE AND TUBING VISUALIZED BY THE RN AND NO BLOOD NOTED. THE PT WAS TURNED TO THE LEFT SIDE WITH ASSISTANCE OF 2 RN'S, TUBING STABILIZED THROUGHOUT. UPON PLACING PT ON THEIR BACK, TUBING REVISUALIZED AND NOTED TO HAVE BRIGHT RED BLOOD IN HELIUM TUBING. IABP CONTINUED TO FUNCTION WITHOUT ANY ALARMS BEING RECORDED OR VISUALIZED. THE PUMP WAS PLACED ON STANDBY; TWO PHYSICIANS WERE CALLED TO THE BEDSIDE. THE PT WAS HEMODYNAMICALLY STABLE THROUGHOUT. THE IAB CATHETER WAS REMOVED WITHOUT INCIDENCE AND NOT REPLACED. PT HAD MULTIPLE CARDIAC PROBLEMS OVER THE PAST FEW WEEKS. IABP LIKELY EXTENDED HER LIFE. PT REMAINED UNSTABLE EVEN WITH IABP; THERE WERE NO PLANS TO REPLACE IT AND IT IS NOT BELIEVED TO BE A CONTRIBUTING FACTOR TO PT'S DEATH. SHE WENT INTO CARDIOGENIC SHOCK AND THE DECISION WAS MADE TO WITHDRAW CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385336 LINEAR 7.5 FR 40CC IAB INTRA-AORTIC BALLOON DSP DATASCOPE CORP., 0684-00-0475 2542

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death