BEUDAMED
    FDA Adverse Event Injury Summary report: N

    J AND J STENT

    MDR report key: 36545 · Received July 3, 1996

    Report

    Report Number
    36545
    Event Type
    Injury
    Date Received
    July 3, 1996
    Date of Event
    June 27, 1996
    Report Date
    July 2, 1996
    Manufacturer
    JOHNSON AND JOHNSON PRODUCTS
    Product Code
    MAF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WITH CORONARY ATHEROSCLEROSIS HAD A PLANNED STENT OF THE RIGHT CORONARY ARTERY. EXPERIENCED A PREMATURE RUPTURE OF THE BALLOON BEFORE REACHING 8ATM. WHILE TRYING TO REMOVE IT, IT OCCLUDED THE INTERNAL DIAMETER OF THE GUIDING CATHETER, PREVENTING REMOVAL OF THE STENT BALLOON CATHETER. THE BALLOON TIP WAS INADVERTANTLY SEVERED DURING THIS PROCESS. TIP RETRIEVED FROM THE CORONARY ARTERY ONLY BY EVENTUALLY REMOVING THE GUIDING CATHETER, BALLOON CATHETER, AND WIRE. SALES REP ON SITE LATER THAT DAY AND TOOK DEVICE FOR FURTHER EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 J AND J STENT Implant STENT MAF JOHNSON AND JOHNSON PRODUCTS PS1530 103281

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention