BEUDAMED
    FDA Adverse Event Other Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 681360 · Received February 28, 2006

    Report

    Report Number
    1317056-2006-00012
    Event Type
    Other
    Date Received
    February 28, 2006
    Date of Event
    January 27, 2006
    Report Date
    January 30, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A STENT PLACEMENT PROCEDURE, THE INFLATION DEVICE WAS FOUND TO BE MALFUNCTIONING. SPECIFICALLY, THE NEEDLE ON THE GAUGE DID NOT MOVE FROM THE ZERO POSITION WHEN THE BALLOON CATHETER WAS INFLATED, THUS THE PRESSURE AT WHICH THE STENT WAS DEPLOYED COULD NOTBE MEASURED. THE PHYSICIAN ASKED FOR ANOTHER INFLATION DEVICE AND THE STENT WAS DEPLOYED COULD NOT BE MEASURED. THE PHYSICIAN ASKED FOR ANOTHER INFLATION DEVICE AND THE STENT WAS DEPLOYED AND POSITIONED SUCCESSFULLY. AT THE CONCLUSION OF THE PROCEDURE4 THE PT DIED. THE REPORT FROM THE HOSPITAL INDICATES THAT "THE PATIENT SUFFERED A SERIOUS CARDIAC CONDITION AND THIS WAS THE 4TH. ANGIOPLASTY SHE GOT INTO. THE STENT WAS CORRECTLY DEPLOYED. THE BALLOON INFLATED/DEFLATED PROPERLY." THE PHYSICIANS WANTED TO REPORT THE DEVICE FAILURE BUT DID NOT FEEL THAT THE DEATH WAS CAUSED BY THE DEVICE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC INFLATION DEVICE MAV BOSTON SCIENTIFIC NA 2001883

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other