BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILLENIA PTCA CATHETER

    MDR report key: 97235 · Received June 4, 1997

    Report

    Report Number
    2083093-1997-00023
    Event Type
    Malfunction
    Date Received
    June 4, 1997
    Date of Event
    May 2, 1997
    Report Date
    May 22, 1997
    Manufacturer
    MEDTRONICS INTERVENTIONAL VASCULAR
    Product Code
    LOX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING AN ATTEMPT TO DEPLOY A STENT THE BALLOON RUPTURED AT 16 ATM (THE RATED BURST). NO INTERVENTION OR PT COMPLICATION WAS REPORTED. HOWEVER, DURING EVALUATION OF THE RETURNED PRODUCT A PERFORATION IN THE BALLOON WAS OBSERVED WITH A RESULTING JETSTREAM TYPE LEAK. ALTHOUGH NO JETSTREAM LEAK WAS REPORTED IN THIS CASE, IT HAS BEEN DETERMINED THAT THIS TYPE OF LEAK MAY CAUSE AN ADVERSE EVENT IF IT WERE TO RECUR. THIS DEVICE WAS USED IN THE SAME CASE AS 2083093-1997-00022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILLENIA PTCA CATHETER CORONARY BALLOON ANGIOPLASTY CATHETER LOX MEDTRONICS INTERVENTIONAL VASCULAR MN2030 70213E2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN J & J STENT