BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT

    MDR report key: 14965 · Received July 29, 1994

    Report

    Report Number
    MW1002981
    Event Type
    Malfunction
    Date Received
    July 29, 1994
    Date of Event
    July 14, 1994
    Report Date
    July 15, 1994
    Manufacturer
    US STENT DIV. SCHNEIDER INTL. LTD.
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DIFFICULT TO FLUSH SALINE, HUB DISCONNECTED FROM PLASTIC SHEATH AND STENT WOULD ONLY DEPLOY 50%. ABLE TO PLACE STENT AFTER THE WIRE GUIDE WAS CUT WITH WIRE CUTTERS AND PLASTIC SHEATH CUT WITH A SCALPEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT BILIARY STENT FGE US STENT DIV. SCHNEIDER INTL. LTD. BEU8-1080-230 9400301

    Patients

    Seq Age Sex Outcome Treatment
    1 *