BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORNADO PLATINUM EMBOLIZATION COIL

    MDR report key: 7738636 · Received August 1, 2018

    Report

    Report Number
    1820334-2018-02220
    Event Type
    Malfunction
    Date Received
    August 1, 2018
    Date of Event
    April 25, 2016
    Report Date
    August 1, 2018
    Manufacturer
    COOK INC
    Product Code
    KRD
    UDI-DI
    00827002130654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MWCE-35-3/7-TORNADO-LEF-HIRATA-061499. THIS MDR IS BEING FILED AFTER THE ASSOCIATED COMPLAINT WAS REVIEWED UNDER REMEDIATION PROTOCOL (B)(4), COMPLAINT/MDR RETROSPECTIVE REVIEW AND REMEDIATION AND REASSESSED AS REPORTABLE. ADDITIONAL COMPLAINT INVESTIGATION AND RECORD REMEDIATION WAS NOT PERFORMED.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT THE COIL GOT STUCK INSIDE A CATHETER, SO THE CATHETER WAS REMOVED FROM THE PATIENT WITH THE COIL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AFTER THE PRODUCTS WERE REPLACED WITH A NEW COIL AND CATHETER. IT WAS FURTHER NOTED THAT THE COIL WAS STRETCHED 3CM (CENTIMETERS) FROM THE PROXIMAL END. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE PRODUCT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579685 TORNADO PLATINUM EMBOLIZATION COIL KRD COOK INC 4618644 00827002130654

    Patients

    Seq Age Sex Outcome Treatment
    1