BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC CORPORATION ENCORE

    MDR report key: 425049 · Received October 28, 2002

    Report

    Report Number
    1317056-2002-00027
    Event Type
    Malfunction
    Date Received
    October 28, 2002
    Date of Event
    September 24, 2002
    Report Date
    October 2, 2002
    Manufacturer
    BOSTON SCIENTIFIC/NAMIC
    Product Code
    MAV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AS REPORTED, DURING SET-UP FOR A PROCEDURE, IT WAS NOTED THAT THE BALLOON CATHETER COULD BE INFLATED, BUT THE GAUGE INDICATOR ON THE INFLATION DEVICE DID NOT MOVE. THERE WAS NO PATIENT INJURY AS THE DEVICE WAS NOT USED ON THE PATIENT. THE DEVICE WAS DISPOSED OF BY THE END USER HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC CORPORATION ENCORE INFLATION DEVICE MAV BOSTON SCIENTIFIC/NAMIC NA 546717

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN