BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KEDDICK CYSTIC DUCT CHOLANGIOGRAM CATH

    MDR report key: 513056 · Received February 11, 2004

    Report

    Report Number
    MW1031213
    Event Type
    Malfunction
    Date Received
    February 11, 2004
    Date of Event
    February 3, 2004
    Report Date
    February 5, 2004
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    GBZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED FOR LAP CHOLE. PRODUCT USE RESULTED IN BALLOON INFLATING IN DUCT AND NOT DEFLATING, REQUIRING RUPTURE OF BALLOON IN DUCT. NO PT INJURY INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KEDDICK CYSTIC DUCT CHOLANGIOGRAM CATH CATHETER GBZ LEMAITRE VASCULAR, INC. 2400-50 1082703-03

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR