BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 2000799 · Received February 24, 2011

    Report

    Report Number
    2024168-2011-01151
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 1, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, 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 CONTRAST ON THE SHAFT, CONSISTENT WITH HANDLING AND POSSIBLY ADVANCEMENT INTO THE ANATOMY. ONLY THE RETRIEVAL CATHETER WAS RETURNED. THERE WAS NO DAMAGE NOTED TO THE EPS. DIFFICULTY ADVANCING THE RETRIEVAL CATHETER CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, DEVICE SIZE SELECTION AND ACCESSORY DEVICE SUPPORT; AND IS TYPICALLY NOT ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY. MEASUREMENTS WERE TAKEN OF THE RETURNED RETRIEVAL CATHETER. PIN GAUGES WERE USED TO MEASURE THE INNER DIAMETER OF THE RETRIEVAL CATHETER. THE MEASUREMENT MET MANUFACTURING CRITERIA. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY RELATED NONCONFORMING MATERIAL RECORDS FOR THIS LOT THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, LOT RELEASE TESTING RESULTS WERE REVIEWED AND ALL SAMPLES MET ALL MANUFACTURING CRITERIA. A DEFINITIVE CAUSE FOR THE REPORTED DIFFICULTY COULD NOT BE DETERMINED. HOWEVER, BASED ON THE RETURNED PRODUCT ANALYSIS, 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: POTENTIAL FACTORS FOR DIFFICULTY ADVANCING A GUIDE WIRE THROUGH THE RAPID EXCHANGE PORT INCLUDE, BIT ARE NOT LIMITED TO, MANUFACTURING, DAMAGE TO THE PROXIMAL END OF THE GUIDE WIRE OR DAMAGE TO THE GUIDE WIRE LUMEN AND/OR EXIT PORT ON THE RETRIEVAL CATHETER. THE REPORTED DIFFICULTY COULD NOT BE CONFIRMED. PIN GAUGES WERE USED TO MEASURE THE INNER DIAMETER OF THE RETRIEVAL CATHETER AND MET MANUFACTURING CRITERIA. DURING FUNCTIONAL TESTING, A NEW BAREWIRE WAS USED TO BACKLOAD THROUGH THE EXIT PORT OF THE RETURNED RETRIEVAL CATHETER UP TO THE STEP WITHOUT RESISTANCE NOTED. THE REPORTED DIFFICULTY COULD NOT BE CONFIRMED ON THE RETURNED DEVICE AND THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RETRIEVAL CATHETER WAS LOADED ONTO THE GUIDE WIRE IN ORDER TO RETRIEVE THE FILTER; HOWEVER, THE DELIVERY CATHETER WOULD NOT ADVANCE FULLY TO RETRIEVE THE CATHETER. AN ACCULINK RETRIEVAL CATHETER WAS USED TO RETRIEVE THE FILTER WITHOUT FURTHER ISSUE. NO PATIENT EFFECTS WERE REPORTED. THE PATIENT WAS DISCHARGED ON (B)(6) 2011. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH, THE FOLLOWING INFORMATION WAS RECEIVED: IT WAS REPORTED THAT DURING A RIGHT INTERNAL CAROTID ARTERY STENTING PROCEDURE, WHILE ADVANCING THE NAV6 RETRIEVAL CATHETER OVER THE WIRE, THE WIRE FAILED TO EXIT FROM THE RETRIEVAL CATHETER EXIT PORT. THEREFORE, THIS EVENT SHOULD NOT HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA-CT 0102851

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention STENT: XACT