BEUDAMED
    FDA Adverse Event Other Summary report: N

    Z-MED II

    MDR report key: 338660 · Received June 20, 2001

    Report

    Report Number
    1318694-2001-00001
    Event Type
    Other
    Date Received
    June 20, 2001
    Report Date
    June 19, 2001
    Manufacturer
    NUMED, INC.
    Product Code
    LIT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PERIPHERAL TRANSLUMINAL ANGIOPLASTY ("PTA") CATHETER WAS USED IN A PT WITH PULMONARY STENOSIS. THE Z-MED II (23 X 4) WOULD NOT PASS OVER THE 14 SHEATH, SHEATH REMOVED AND BALLOON TRIED TO PASS INTO VEIN ITSELF BUT BALLOON WINGED. FINALLY AFTER ONE HOUR THE CATHETER WAS REPLACED WITH A TYSHAK 20 X 4 AND THIS WENT WELL. THE PT DEVELOPED PULMONARY OEDEMA AND WAS DISCHARGED IN TWO WEEKS POST PROCEDURE AND IS DOING VERY WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28006 Z-MED II PTA CATHETER LIT NUMED, INC. 305 ZZ-0063

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization| O