BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 2001931 · Received February 27, 2011

    Report

    Report Number
    2024168-2011-01229
    Event Type
    Malfunction
    Date Received
    February 27, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 20, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. EVALUATION SUMMARY: EVALUATION OF THE RETURNED EMBOLIC PROTECTION SYSTEM (EPS) NOTED BLOOD AND SALINE ON THE HANDLE AND SHAFT AND IN THE SHAFT, CONSISTENT WITH BEING ADVANCED INTO THE ANATOMY AS REPORTED. ONLY THE DELIVERY CATHETER WAS RETURNED. THE FILTRATION ELEMENT, BAREWIRE, RED LOCKING CLIP, TORQUE DEVICE, RETRIEVAL CATHETER AND TRAY WERE NOT RETURNED. THE WHITE PULL HANDLE OF THE EPS WAS RETURNED FULLY RETRACTED. THE DELIVERY CATHETER (DC) POD WAS SLIGHTLY WRINKLED 15 MM AND 17 MM DISTAL TO THE MARKER. THERE WAS NO OTHER DAMAGE NOTED TO THE EPS. DURING FUNCTIONAL TESTING, THE WHITE PULL HANDLE WAS RETRACTED SEVERAL TIMES AND THE FILTRATION ELEMENT WAS NOT INSIDE THE EPS. ADDITIONAL INFORMATION RECEIVED FROM THE ACCOUNT STATED THAT THE FILTER DID NOT REMAIN IN THE PATIENT. IMAGES WERE TAKEN WITH FLUOROSCOPY OF THE CAROTID AND CEREBRAL ARTERIES AND THERE WAS NO VISUAL SIGN OF THE FILTER ELEMENT. IT WAS SUSPECTED THAT THE EPD WAS NEVER DEPLOYED IN THE CAROTID AND WAS ACCIDENTLY DEPLOYED AFTER REMOVAL FROM THE ANATOMY, BUT CANNOT BE CONFIRMED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT. BASED ON THE ANALYSIS OF THE RETURNED DELIVERY CATHETER AND UPDATED INFORMATION FROM THE ACCOUNT, IT APPEARS THAT THE FILTRATION ELEMENT WAS NEVER DEPLOYED AND WAS POSSIBLY DEPLOYED ON THE TABLE OUTSIDE OF THE ANATOMY AND DISCARDED PRIOR TO RETURN. THE WRINKLING NOTED TO THE DELIVERY CATHETER POD WAS LIKELY DUE TO HANDLING PRIOR TO RETURN. THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY. AS PART OF MANUFACTURING QUALITY PROCESS, ALL DELIVERY CATHETERS ARE INSPECTED TO ENSURE THE DEVICE STRUCTURE AND INTEGRITY. ADDITIONALLY, A SAMPLING OF UNITS IS VISUALLY, DIMENSIONALLY AND FUNCTIONALLY INSPECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT COMMON CAROTID PROCEDURE, THE EMBOSHIEILD NAV6 WAS PREPARED AND ADVANCED TO THE TARGET LESION. AFTER 'DEPLOYMENT' OF THE EMBOLIC PROTECTION DEVICE (EPD) AND REMOVAL OF THE DELIVERY CATHETER THE EPD COULD NOT BE VISUALIZED IN THE VESSEL. THE BAREWIRE WAS 'TUGGED/PULLED' AND NO EPD WAS PRESENT. IT IS SUSPECTED THAT THE EPD REMAINED IN THE DELIVERY CATHETER. A SECOND NAV6 WAS USED IN THE PROCEDURE WITHOUT ISSUE. THERE WAS NO REPORTED PATIENT EFFECT AND THERE WAS NO SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. DEVICE ANALYSIS REVEALED THE EMBOLIC PROTECTION DEVICE (EPD) WAS NOT RETURNED IN THE DELIVERY CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA-CT 0102251

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR