BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM

    MDR report key: 4094036 · Received September 16, 2014

    Report

    Report Number
    2183870-2014-00233
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 11, 2014
    Report Date
    September 25, 2024
    Manufacturer
    COVIDIEN
    Product Code
    FGE
    PMA / PMN Number
    P110023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT.ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD IT BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PROTEGE EVERFLEX STENT WAS PLACED ON .035 WIRE THROUGH A 6F SHEATH. THE PROTEGE EVERFLEX STENT BECAME STUCK ON THE WIRE WHEN BEING DELIVERED TO RIGHT TPT. THE STENT COULD NOT BE DELIVERED TO LESION AND THE WIRE AND STENT HAD TO BE REMOVED TOGETHER. AS A RESULT, THE PATIENT WAS NOT ABLE TO BE TREATED. THE PATIENT WILL BE BROUGHT BACK FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572751 PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE COVIDIEN PRB35-05020120 9910059

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other .035 AMPLATZ WIRE| 6F RAABE SHEATH| .035 AMPLATZ WIRE| 6F RAABE SHEATH