BEUDAMED
    FDA Adverse Event Injury Summary report: N

    15MM NC BANDIT PTCA CATHETER

    MDR report key: 46215 · Received July 30, 1996

    Report

    Report Number
    46215
    Event Type
    Injury
    Date Received
    July 30, 1996
    Date of Event
    June 7, 1996
    Report Date
    June 18, 1996
    Manufacturer
    SCIMED LIFE SYSTEMS, INC.
    Product Code
    LOX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS RECEIVING A SINGLE CORONARY STENT TO HIS PROXIMAL LAD; WHEN A BALLOON PTCA CATHETER USED FOR PRE AND PEST DILATION RUPTURED CAUSING A DISSECTION OF PT'S CORONARY ARTERY. THIS REQUIRED IMMEDIATE SURGICAL INTERVENTION (BYPASS/CABG). APPEARS THE PT WILL RECOVER FROM THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 15MM NC BANDIT PTCA CATHETER Implant SCIMED DILATING CATHETER LOX SCIMED LIFE SYSTEMS, INC. 13070-35 515038

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| L