BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT

    MDR report key: 6740944 · Received July 25, 2017

    Report

    Report Number
    1820334-2017-02065
    Event Type
    Malfunction
    Date Received
    July 25, 2017
    Date of Event
    November 1, 2016
    Report Date
    July 25, 2017
    Manufacturer
    COOK INC
    Product Code
    NIO
    UDI-DI
    10827002501703
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON NAME: CATHETER, BILIARY, DIAGNOSTIC. PRODUCT CODE: FGE. (B)(4). PMA/510(K) #: K080037 INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DIMENSIONAL VERIFICATION, DEVICE HISTORY RECORD, MANUFACTURING INSTRUCTIONS, TRENDS, FUNCTIONAL TESTING, AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT WAS RETURNED FOR EVALUATION WITHOUT THE ORIGINAL PACKAGING. UPON EVALUATION, THE DEVICE WAS ABLE TO BE FLUSHED WITHOUT ISSUE. THERE WAS EVIDENCE OF COMPRESSION OF THE FLEXOR AND THE DISTAL WHITE TIP WAS DAMAGED, INDICATING SEVERE RESISTANCE WHEN ADVANCING OVER THE WIRE GUIDE. THE DEVICE WAS ABLE TO BE WIRED WITH A 0.035¿ DIAMETER WIRE GUIDE WITH NO ISSUES NOTED. BUCKLING WAS OBSERVED ON THE OUTER SHEATH BETWEEN 6CM AND 12CM FROM THE DISTAL WHITE TIP. THE DISTAL END OF THE OUTER SHEATH WAS DAMAGED. REVIEW OF DEVICE HISTORY RECORD SHOWS NO DISCREPANCIES THAT COULD CONTRIBUTE TO THIS COMPLAINT. THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED AND RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. PER THE RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT GOT STUCK AND PULLED OUT ON THE WIRE. THE CUSTOMER REPORTED THAT IT LOOKED FINE OUT OF THE PACKAGING. THE DEVICE DID NOT MAKE PATIENT CONTACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER STENT. THIS PROBLEM DID NOT CREATE THE NEED FOR ANY INTERVENTION OR ADDITIONAL PROCEDURES. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520138 ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT NIO COOK INC N/A 10827002501703

    Patients

    Seq Age Sex Outcome Treatment
    1