BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TORNADO PLATINUM EMBOLIZATION MICROCOIL

    MDR report key: 5032648 · Received August 26, 2015

    Report

    Report Number
    1820334-2015-00514
    Event Type
    Injury
    Date Received
    August 26, 2015
    Date of Event
    July 30, 2015
    Report Date
    August 4, 2015
    Manufacturer
    COOK INC
    Product Code
    KRD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MWCE-18S-8/4-TORNADO-081800. (B)(4) THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT EVALUATION: A REVIEW OF COMPLAINT HISTORY, DRAWING, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL AND TRENDS WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED TO ASSIST IN THE INVESTIGATION. A REVIEW OF FIELD COMPLAINTS AND PRODUCTION RECORDS FOR THE PROVIDE LOT WAS CONDUCTED. IT WAS DETERMINED THAT THERE ARE NO ADDITIONAL FIELD COMPLAINTS REPORTED AT THE TIME OF INVESTIGATION PERTAINING TO THIS LOT. THERE WERE NO RECORDED NONCONFORMANCES DURING PRODUCTION OF THE COMPLAINT LOT. THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED TO SPECIFICATION. THE DEVICE IS PACKAGED WITH IFU. THE IFU GIVES DEVICE DESCRIPTION, INTENDED USE, WARNINGS, PRECAUTIONS, RECOMMENDATIONS AND INSTRUCTIONS FOR PLACEMENT AND USE OF THE DEVICE. THE IFU INCLUDES THE WARNING, "POSITIONING OF EMBOLIZATION COILS SHOULD BE DONE WITH PARTICULAR CARE. COILS SHOULD NOT BE LEFT TOO CLOSE TO INLETS OF ARTERIES AND SHOULD BE INTERMESHED WITH PREVIOUSLY PLACED COILS IF POSSIBLE. A MINIMAL BUT SUFFICIENT ARTERIAL BLOOD FLOW SHOULD REMAIN TO HOLD THE COILS AGAINST THE PREVIOUSLY PLACED COILS UNTIL A SOLID CLOT ENSURES PERMANENT FIXATION. THE PURPOSE OF THESE SUGGESTIONS IS TO MINIMIZE THE POSSIBILITY OF LOOSE COILS BECOMING DISLODGED AND OBSTRUCTING A NORMAL AND ESSENTIAL ARTERIAL CHANNEL." BASED ON THE CUSTOMER REPORT AND THE PHYSICIAN'S STATEMENT IT IS FEASIBLE TO SUGGEST THAT USER TECHNIQUE LED TO THE REPORTED MIGRATION OF THE COIL. PER THE CONCLUSION OF A QUALITY ENGINEERING RISK ASSESSMENT, FURTHER RISK REDUCTION IS NOT REQUIRED. WE HAVE NOTIFIED THE APPROPRIATE INTERNAL PERSONNEL AND WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DURING A COIL EMBOLIZATION OF THE RIGHT RENAL ARTERIOVENOUS FISTULA, THE COIL WAS NOT PLACED AT THE DESIRED LOCATION AND MIGRATED. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE MIGRATED COIL WITH ANOTHER MANUFACTURER'S SNARE, HOWEVER THE COIL SEPARATED AND PART OF THE COIL REMAINED IN THE RIGHT ATRIUM. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL AND IS TAKEN WAIT-AND-SEE APPROACH. THE PHYSICIAN RECOGNIZED THAT THE COIL USED FOR THE PROCEDURE WAS NOT THE CORRECT SIZE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED SO FAR. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER IT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    DURING A COIL EMBOLIZATION OF THE RIGHT RENAL ARTERIOVENOUS FISTULA, THE COIL WAS NOT PLACED AT THE DESIRED LOCATION AND MIGRATED. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE MIGRATED COIL WITH ANOTHER MANUFACTURER'S SNARE, HOWEVER THE COIL SEPARATED AND PART OF THE COIL REMAINED IN THE RIGHT ATRIUM. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL AND IS TAKING A WAIT-AND-SEE APPROACH. THE PHYSICIAN RECOGNIZED THAT THE COIL USED FOR THE PROCEDURE WAS NOT THE CORRECT SIZE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED SO FAR. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER IT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565262 TORNADO PLATINUM EMBOLIZATION MICROCOIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1