BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIB CATHETER

    MDR report key: 291456 · Received August 16, 2000

    Report

    Report Number
    1318694-2000-00009
    Event Type
    Other
    Date Received
    August 16, 2000
    Date of Event
    August 27, 1999
    Report Date
    August 16, 2000
    Manufacturer
    NUMED, INC.
    Product Code
    LIT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A PERIPHERAL TRANSLUMINAL ANGIOPLASTY ("PTA") CATHETER WAS USED TO PERFORM A DEPLOYMENT OF A J & J PALMAZ BALLOON EXPANDABLE #P308M STENT ON A PT. THE OUTER BALLOON REMAINED INFLATED. THE BALLOON WAS INTENTIONALLY OVER-INFLATED TO CAUSE IT TO BURST. THE PT REMAINED STABLE WITH NO HEMODYNAMIC CHANGES AND SUFFERED NO HARMFUL EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIB CATHETER PTA CATHETER LIT NUMED, INC. 420 BIB-0128

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR STENT.