BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 1953210 · Received January 7, 2011

    Report

    Report Number
    2024168-2011-00138
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 14, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EMBOLIC PROTECTION SYSTEM (EPS) WAS RETURNED WITH BLOOD ON THE DELIVERY CATHETER SHAFT, ON THE FILTRATION ELEMENT AND ON THE BARE WIRE COILS WHICH IS CONSISTENT WITH HANDLING. ONLY THE FILTRATION ELEMENT, DELIVERY CATHETER AND BARE WIRE WERE RETURNED. THE FILTRATION ELEMENT WAS RETURNED ON THE BARE WIRE, LOCATED AT THE STEP AND WAS PARTIALLY LOADED IN THE DELIVERY CATHETER POD (DC POD). THERE WAS 7 MM OF THE FILTRATION ELEMENT PROTRUDING FROM THE DC POD. THERE WAS NO DAMAGE NOTED TO THE FILTRATION ELEMENT. THE DC POD WAS SEPARATED 5 MM DISTAL TO THE MARKER. THE FRACTURE FACE WAS JAGGED AND THERE WERE LONGITUDINAL SCRATCH MARKS ON THE DC POD DISTAL TO THE SEPARATION. THE JAGGED FRACTURE FACE ALONG WITH THE SCRATCHES SUGGESTS MECHANICAL DAMAGE. THERE WAS NO OTHER DAMAGE NOTED TO THE DELIVERY CATHETER. THE RED LOCKING CLIP WAS RETURNED CLAMPED ON THE DELIVERY CATHETER HANDLE. THERE WAS NO DAMAGE NOTED TO THE BARE WIRE. THE TORQUE DEVICE WAS RETURNED SECURED ON THE BARE WIRE AND WAS LOCATED 8.2 CM PROXIMAL TO THE SILVER PORTION ON THE BARE WIRE, SUGGESTING THAT THE TORQUE DEVICE MAY HAVE SLIPPED, POSSIBLE DURING ATTEMPTS TO LOAD THE FILTRATION ELEMENT INTO THE DC POD. THERE WAS NO OTHER DAMAGE NOTED TO THE EPS. THE PUSHER LENGTH WAS MEASURED AND MET MANUFACTURING CRITERIA. ADDITIONALLY, THE FILTRATION ELEMENT LENGTH WAS MEASURED AND MET MANUFACTURING CRITERIA. BASED ON THE APPEARANCE OF THE SEPARATION (JAGGED WITH SCRATCHES), IT APPEARS THAT THE SEPARATION IS A RESULT OF MECHANICAL DAMAGE POSSIBLY DUE TO INTERACTION BETWEEN THE DELIVERY CATHETER POD AND ASSOCIATED DEVICES AND/OR THE DISPENSER COIL DURING PREPARATION. AS THIS DAMAGE WAS NOT REPORTED DURING THE INITIAL PRIOR TO INSPECTION, IT IS POSSIBLE THAT THE DAMAGE OCCURRED AS A RESULT OF HANDLING DURING USE, OR DURING PREPARATION. TO ENSURE THIS IS NOT A MANUFACTURING DEFICIENCY, ALL EMBOSHIELD NAV 6 PODS ARE DIMENSIONALLY INSPECTED FOR INNER AND OUTER DIAMETER, WALL THICKNESS AND POD LENGTH AND A 100% IN PROCESS INSPECTION IS PERFORMED TO ENSURE APPROPRIATE POLYIMIDE PUSHER TRIM LENGTH. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS EVENT. A CONCLUSIVE CAUSE FOR THE SEPARATION AND SUBSEQUENT DAMAGE COULD NOT BE DETERMINED. HOWEVER, THERE IS NO INDICATION TO SUGGEST A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE PREPARATION, WHEN THE EMBOSHIELD NAV 6 WAS REMOVED FROM THE HOOP, IT WAS NOTICED THAT THE DISTAL TIP WAS DAMAGED/BROKEN. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED. INVESTIGATION OF THE RETURNED DEVICE FOUND THE DELIVERY CATHETER POD WAS SEPARATED DISTAL TO THE MARKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA-CT 0052751

    Patients

    Seq Age Sex Outcome Treatment
    1