BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOHNSON & JOHNSON CORDIS CORPORATION

    MDR report key: 104938 · Received July 10, 1997

    Report

    Report Number
    104938
    Event Type
    Malfunction
    Date Received
    July 10, 1997
    Date of Event
    June 23, 1997
    Report Date
    July 7, 1997
    Manufacturer
    CORDIS CORP
    Product Code
    MAF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT IN CATH LAB FOR PTCA & STENT PLACEMENT. AT TIME OF STENT PLACEMENT DELIVERY BALLOON RUPTURED AT 3 ATM OF INFLATION. THE BALLOON WAS IMMEDIATELY DEFLATED, REMOVED AND EXCHANGED WITH 3.0 NC BANDIT BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOHNSON & JOHNSON CORDIS CORPORATION Implant PTCA STENT PALMAZ-SCHATZ STENT MAF CORDIS CORP * 131311

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR