BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 6443486 · Received March 29, 2017

    Report

    Report Number
    1820334-2017-00549
    Event Type
    Malfunction
    Date Received
    March 29, 2017
    Report Date
    April 10, 2017
    Manufacturer
    COOK INC
    Product Code
    NIN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: NEW INFORMATION HAS BEEN MADE AVAILABLE AND THIS PRODUCT IS NOT MANUFACTURED BY COOK MEDICAL. THE FOLLOWING INFORMATION WAS RECEIVED ON 29MAR2017 BY THE LEAD TECH AT THE REPORTING FACILITY, (B)(6) HOSPITAL: ¿AFTER FURTHER REVIEW OF THIS CASE I REALIZED THAT THEY WERE NOT COOK STENTS AFTER ALL. THESE WERE EV3 PARAMOUNT MINI STENTS AND CORDIS PALMAZ BLUE STENTS. THIS PROCEDURE WAS BEFORE WE BROUGHT IN THE FORMULA STENTS IN 2012.¿

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR 2 STENTS OF AN UNKNOWN PART AND LOT NUMBER. (B)(4). PMA/510(K) # : P100028. THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANGIOGRAM, THE CARDIOLOGIST NOTED THAT THE PATIENT'S FORMULA STENTS WERE BOTH OCCLUDED. THERE WERE TWO OF THEM. THE LOT NUMBER AND DEVICE NAME WAS REQUESTED BUT HAVE NOT BEEN PROVIDED. THE USER FACILITY STATES THEY BELIEVE THE STENTS ARE FRACTURED. THERE WAS NO INFORMATION PROVIDED TO INDICATE ANY INTERVENTION BEING PERFORMED. ADDITIONAL INFORMATION REGARDING THE DETAILS OF THE EVENT WAS REQUESTED BUT IT HAS NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223856 UNKNOWN NIN COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1