BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORNADO PLATINUM EMBOLIZATION MICROCOIL

    MDR report key: 6118006 · Received November 21, 2016

    Report

    Report Number
    1820334-2016-01330
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    October 27, 2016
    Report Date
    August 11, 2017
    Manufacturer
    COOK INC
    Product Code
    KRD
    UDI-DI
    00827002132863
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION: A REVIEW OF THE DEVICE HISTORY RECORD, MANUFACTURING INSTRUCTIONS, DRAWING, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL DATA WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE NO PHYSICAL EXAMINATION COULD BE PERFORMED. HOWEVER, A DOCUMENT-BASED INVESTIGATION WAS PERFORMED. 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. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF OUR INVESTIGATION; A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. CATALOGUE NUMBER : MWCE-18S-4/8-TORNADO-LEF-081800. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN THE COMPLAINT COIL WAS PUSHED INTO A CATHETER FROM THE LOADING CARTRIDGE, RESISTANCE WAS ENCOUNTERED. THE PHYSICIAN CHECKED THE CATHETER AND FOUND THE COIL WAS STUCK IN THE HUB AND WAS UNRAVELED INSIDE IT. THE CATHETER WAS RETRIEVED FROM THE BODY WITH THE UNRAVELED COIL STILL INSIDE THE HUB OF IT. ANOTHER CATHETER WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769866 TORNADO PLATINUM EMBOLIZATION MICROCOIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD COOK INC N/A 00827002132863

    Patients

    Seq Age Sex Outcome Treatment
    1