BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORNADO PLATINUM EMBOLIZATION COIL

    MDR report key: 6866241 · Received September 14, 2017

    Report

    Report Number
    1820334-2017-02632
    Event Type
    Malfunction
    Date Received
    September 14, 2017
    Date of Event
    August 24, 2017
    Report Date
    February 6, 2018
    Manufacturer
    COOK INC
    Product Code
    KRD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    POTENTIAL LOT NUMBERS: 6985284, 7678658, 7678658, 7692737, 7698168, 7881910. CATALOG #: MWCE-35-5/10-TORNADO-LEF-HIRATA-061499. (B)(6). (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION: PMA/510(K) #: PREAMENDMENT. A REVIEW OF THE COMPLAINT HISTORY, DRAWINGS, DIMENSIONAL VERIFICATION, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, QUALITY CONTROL, AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE PRODUCT WAS RETURNED. MEASUREMENTS OF THE "NEEDLE-LIKE METAL PIECE" WERE PERFORMED AND THE DEVICE FAILURE ANALYSIS REVEALED THAT BASED ON VISUAL INSPECTION AND MEASUREMENT OF OUTER DIAMETER, THIS OBJECT IS POSSIBLY THE WORKING STYLET FROM THE PRODUCTION PROCESS. A DOCUMENT-BASED INVESTIGATION WAS PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS FOR ALL REPORTED LOT NUMBERS SHOW NO NONCONFORMING EVENTS THAT WOULD CONTRIBUTE TO THIS FAILURE MODE. IN ADDITION, THERE WERE ONLY TWO ADDITIONAL COMPLAINTS REPORTED FROM ALL THE POSSIBLE LOT NUMBERS PROVIDED. THE WORKING STYLET MAY NOT HAVE BEEN REMOVED AND DISCARDED FROM THE SHIPPING CARTRIDGE AFTER QUALITY CONTROL INSPECTION. QUALITY CONTROL STATES TO REMOVE THE WORKING STYLET AFTER LOADING THE COIL INTO THE SHIPPING CANNULA. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION; THE ROOT CAUSE FOR THIS EVENT HAS BEEN ATTRIBUTED TO MANUFACTURING (OPERATOR RELATED). MEASURES HAVE BEEN INITIATED TO ADDRESS THIS FAILURE MODE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED THAT, AFTER DEPLOYING SEVERAL TORNADO PLATINUM EMBOLIZATION COILS DURING AN INTERNAL ILIAC ARTERY (IIA) EMBOLIZATION, ONE OF THE COILS BECAME STUCK IN THE CATHETER. THE COIL WAS THEN REMOVED FROM THE CATHETER, AND THE OPERATOR OF THE DEVICE CONFIRMED THE PRESENCE OF NEEDLE-LIKE PIECE OF METAL INSIDE THE CATHETER. THE PIECE OF METAL WAS FURTHER CHARACTERIZED BY THE CUSTOMER AS RESEMBLING A "METAL WIRE." THE CATHETER WAS SUBSEQUENTLY REMOVED FROM THE PATIENT'S BODY. THE METAL PIECE WAS ESTIMATED TO BE APPROXIMATELY 10 CM IN LENGTH. ANOTHER CATHETER AND COIL OF THE SAME TYPE WERE USED TO COMPLETE THE PROCEDURE. THE EXACT LOT NUMBER OF THE DEVICE IS NOT KNOWN, BUT THE CUSTOMER DID REPORT A RANGE OF LOTS THAT THEY BELIEVE THE DEVICE MAY CORRESPOND TO. THE COMPLAINT COIL WAS REPORTEDLY DISCARDED AT THE FACILITY; HOWEVER, THE METAL PIECE WAS RETURNED FOR INVESTIGATION. THE INVESTIGATION IS CURRENTLY PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646330 TORNADO PLATINUM EMBOLIZATION COIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1