BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORNADO PLATINUM EMBOLIZATION MICROCOIL

    MDR report key: 24483348 · Received March 2, 2026

    Report

    Report Number
    1820334-2026-00230
    Event Type
    Malfunction
    Date Received
    March 2, 2026
    Date of Event
    December 18, 2025
    Report Date
    May 19, 2026
    Manufacturer
    COOK INC
    Product Code
    KRD
    UDI-DI
    00827002131071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D4: CATALOG #: MWCE-18S-2/4-TORNADO-LEF-081800. G4: PMA/510(K): PREAMENDMENT. H3: DEVICE EVALUATED BY MFG?: THE DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A TORNADO PLATINUM EMBOLIZATION MICROCOIL WAS DIFFICULT TO ADVANCE THROUGH A COMPETITOR CATHETER DURING AN UNKNOWN PROCEDURE FOR AN UNKNOWN PATIENT. THE 4FR CATHETER WAS FLUSHED, AND DURING ATTEMPTED DELIVERY OF THE COIL, RESISTANCE WAS ENCOUNTERED. A PORTION OF THE COIL EXITED THE DISTAL TIP OF THE CATHETER BUT WAS UNABLE TO BE FULLY DEPLOYED. A NEW COMPETITOR CATHETER AND COIL WERE USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621378 TORNADO PLATINUM EMBOLIZATION MICROCOIL KRD; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD COOK INC G13107 15692741 00827002131071

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown BOSTON SCIENTIFIC: BREAKTHROUGH CATHETER 0.018.