BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 75237 · Received March 7, 1997

    Report

    Report Number
    75237
    Event Type
    Other
    Date Received
    March 7, 1997
    Date of Event
    February 3, 1997
    Report Date
    February 7, 1997
    Manufacturer
    NEW JERSEY PLANT
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT A STENT DEPLOYMENT TO THE RCA. THE LESION WAS EASILY CROSSED AND PRE-DILATED WITH 2.5 BALLOON AT 8.0 ATM PRESSURE. THEN THE 3MM STENT WAS ADVANCED WITHOUT DIFFICULTY. HOWEVER, THE STENT SHEATH WAS WITHDRAWN, AND THE STEN WAS EXPOSED-- FAILED TO CROSS THE LESION WITH THIS STENT. SUBSEQUENTLY, STENT, BALLOON, WIRE AND GIUDING CATHETER WERE REMOVED AS ONE UNIT. FAILED TO RECOVER STENT EITHER IN THE CATHETER, SHEATH OR ARTERIAL SHEATH. ASSUMED STENT WAS LOST BELOW DIAPHRAM AND REMAINS IN PT. THE PROCEDURE WAS COMPLETED WITHOUT DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * MAF NEW JERSEY PLANT NA 120891

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other