BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORNADO PLATINUM EMBOLIZATION MICROCOIL

    MDR report key: 7623152 · Received June 20, 2018

    Report

    Report Number
    1820334-2018-01936
    Event Type
    Malfunction
    Date Received
    June 20, 2018
    Date of Event
    February 17, 2015
    Report Date
    June 20, 2018
    Manufacturer
    COOK INC
    Product Code
    KRD
    UDI-DI
    00827002133655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL: MWCE-18S-5/10-TORNADO-LEF-081800. 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

    IT WAS REPORTED THAT DURING THE PROCEDURE WHEN THE TORNADO PLATINUM EMBOLIZATION MICROCOIL WAS USED, THE LUER LOCK CAME LOOSE FROM THE MICRO CATHETER HUB. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. HOWEVER, IT WAS NOTED FURTHER THAT THE COIL WAS STRETCHED ON THE DISTAL END. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465838 TORNADO PLATINUM EMBOLIZATION MICROCOIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD COOK INC F4602628 00827002133655

    Patients

    Seq Age Sex Outcome Treatment
    1