BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENT INSERTION CATHETER, 3.5 STENT

    MDR report key: 27166 · Received October 18, 1995

    Report

    Report Number
    MW1007356
    Event Type
    Malfunction
    Date Received
    October 18, 1995
    Date of Event
    September 26, 1995
    Report Date
    September 28, 1995
    Manufacturer
    JOHNSON & JOHNSON INTERVENTIONAL SERVICES
    Product Code
    MAF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LEAK IN BALLOON NOTED DURING ATTEMPTS TO PLACE STENT FOR A LAO LESION IN CORONARY ARTERY. DIFFICULTY WAS ENCOUNTERED IN DEPLOYING THE STEN DUE TO THE LEAK IN THE BALLOON. STENT WAS EVENTUALLY DEPLOYED WITH GOOD RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STENT INSERTION CATHETER, 3.5 STENT CATHETER MAF JOHNSON & JOHNSON INTERVENTIONAL SERVICES UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR