BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUTTING BALLOON

    MDR report key: 302950 · Received November 3, 2000

    Report

    Report Number
    2024805-2000-00007
    Event Type
    Injury
    Date Received
    November 3, 2000
    Date of Event
    October 26, 2000
    Report Date
    October 31, 2000
    Manufacturer
    INTERVENTIONAL TECH, INC.
    Product Code
    LOX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AFTER ONE INFLATION THE PHYSICIAN REMOVED THE CUTTING BALLOON DEVICE FROM THE PT. THE PHYSICIAN THEN ATTEMPTED TO RE-PREP THE DEVICE FOR RE-INSERTION INTO THE SAME PT. DURING THE RE-PREP, THE BALLOON WOULD NOT PULL A NEGATIVE, THE DECISION WAS THEN MADE TO INFLATE THE BALLOON WITH CONTRAST MEDIA TO SEE IF THE BALLOON WAS LEAKING. WHILE APPLYING PRESSURE TO THE BALLOON, CONTRAST MEDIA "SHOT OUT" OF THE BALLOON, HITTING THE NURSE WHO WAS STANDING 4-5 FT AWAY IN THE EYE. THE NURSE WAS TREATED BY FLUSHING THE EYE OUT AND APPLYING ANESTHETIC EYE DROPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUTTING BALLOON PTCA LOX INTERVENTIONAL TECH, INC. B135010 F0021406

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention