BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILLENIA PTCA CATHETER

    MDR report key: 83104 · Received April 7, 1997

    Report

    Report Number
    2083093-1997-00009
    Event Type
    Malfunction
    Date Received
    April 7, 1997
    Report Date
    April 4, 1997
    Manufacturer
    MEDTRONICS INTERVENTIONAL VASCULAR
    Product Code
    LOX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING POST DILATATION OF A STENT THE PTCA BALLOON BURST AT 8 ATM (8ATM BELOW BURST RATE). NO PT INJURY OR COMPLICATION OCCURRED AND NO INTERVENTION WAS REQUIRED. DURING PRODUCT EVALUATION A JETSTREAM LEAK WAS DETECTED. ALTHOUGH NO JETSTREAM LEAK WAS REPORTED DURING THE EVENT AND NO PT COMPLICATIONS OR INTERVENTION OCCURRED, SUCH A LEAK MAY CAUSE AN ADVERSE EVENT IF IT WERE TO RECUR. NOTE: TWO DEVICES WITH THE SAME LOT, 70102C2, WERE INVOLVED IN THIS CASE. REFERENCE 2083093-1997-00010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILLENIA PTCA CATHETER CORONARY BALLOON ANGIOPLSTY CATHETER LOX MEDTRONICS INTERVENTIONAL VASCULAR MN2030 70102C2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN J & J STENT