BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT

    MDR report key: 6357274 · Received February 24, 2017

    Report

    Report Number
    1820334-2017-00307
    Event Type
    Malfunction
    Date Received
    February 24, 2017
    Date of Event
    January 25, 2017
    Report Date
    June 24, 2017
    Manufacturer
    COOK INC
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510K K080037. THE REPORTED DEVICE HAS BEEN RECEIVED, AN EVALUATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, MANUFACTURING INSTRUCTIONS, TRENDS, QUALITY CONTROL, AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. ONE ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT WAS RETURNED FOR EVALUATION WITHOUT THE ORIGINAL PACKAGING. THE HANDLE WAS CRACKED WITH PIECES BROKEN OFF OF THE DEVICE. THE CRACKING WAS OBSERVED ON THE DISTAL PART OF THE HANDLE AT THE SNAP JOINT BETWEEN THE HANDLE AND THE HANDLE EXTENSION. THERE IS NO EVIDENCE TO SUGGEST THE FINISHED PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT SHOWS NO NONCONFORMING EVENTS THAT WOULD CONTRIBUTE TO THIS FAILURE MODE. THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. MEASURES HAVE BEEN CONDUCTED TO ADDRESS THIS FAILURE MODE. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    AS REPORTED TO CUSTOMER RELATIONS: AFTER OPENING THE PACKAGE AND REMOVING THE ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT FROM THE TRAY, IT WAS NOTICED THAT THE STENT WAS CRACKED ON THE BACK SHAFT. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2017, IT WAS ADDITIONALLY REPORTED THE BLACK HANDLE OF THE DEVICE IS BROKEN. THE STENT WAS BROKEN STRAIGHT OUT OF THE PACKAGE. NO PATIENT CONTACT WAS MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139459 ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1