BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 2791926 · Received October 15, 2012

    Report

    Report Number
    2024168-2012-06519
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    September 21, 2012
    Report Date
    September 21, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. DEVICE (B)(4) - INCORRECT REMOVAL. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE PREMATURE DEPLOYMENT COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON A VISUAL AND FUNCTIONAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. IT WAS REPORTED THE FILTER ELEMENT WAS REMOVED FROM THE PATIENT ANATOMY FULLY DEPLOYED. IT SHOULD BE NOTED THE EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM INSTRUCTIONS FOR USE (IFU) STATES: PULL ON THE TIGHTENED TORQUE DEVICE TO RETRACT THE BAREWIRE FILTER DELIVERY WIRE UNTIL THE FILTRATION ELEMENT IS FULLY ENCLOSED IN THE RADIOPAQUE EXPANDABLE TIP. COMPLETE RETRIEVAL OF THE FILTRATION ELEMENT HAS BEEN ACHIEVED WHEN THE DISTAL FILTRATION ELEMENT MARKER BAND HAS BEEN WITHDRAWN TO WITHIN 2 MM OF THE DISTAL END OF THE RADIOPAQUE CATHETER TIP. IN THIS CASE, THE REMOVAL OF THE FILTRATION ELEMENT IN THE OPEN POSITION DOES NOT APPEAR TO HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE INTERNAL CAROTID ARTERY THAT WAS MILDLY TORTUOUS. AFTER THE FILTER WAS PLACED AT THE JUNCTION OF THE COMMON AND INTERNAL CAROTID ARTERY, THE FILTER PREDEPLOYED. THE FILTER HAD NOT BEEN UNLOCKED, THE WHITE HANDLE WAS INTACT AND THE RED SAFETY HAD NOT BEEN DEPLOYED. THE FILTER WAS RETRIEVED FROM THE PATIENT FULLY DEPLOYED; HOWEVER, THERE WAS NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. A NEW NAV 6 WAS USED TO COMPLETE THE CASE SUCCESSFULLY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA-CT 1091261

    Patients

    Seq Age Sex Outcome Treatment
    1 CONCOMITANT MEDICAL DEVICES