BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC CORPORATION ENCORE

    MDR report key: 425053 · Received October 28, 2002

    Report

    Report Number
    1317056-2002-00026
    Event Type
    Malfunction
    Date Received
    October 28, 2002
    Date of Event
    September 9, 2002
    Report Date
    September 30, 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 A PROCEDURE UTILIZING AN INFLATION DEVICE, THE BALLOON ON THE CATHETER INFLATED, BUT THE GAUGE INDICATOR DID NOT REGISTER PRESSURE. THERE WAS NO PATIENT INJURY. THE DEVICE HAS BEEN 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 543487

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN