BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX ACCUNET EMBOLIC PROTECTION SYSTEM

    MDR report key: 1000766 · Received February 18, 2008

    Report

    Report Number
    3004742046-2008-00036
    Event Type
    Malfunction
    Date Received
    February 18, 2008
    Report Date
    December 12, 2007
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NTE
    PMA / PMN Number
    K052166
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE RX ACCUNET WAS RETURNED WITH BLOOD VISIBLE ON THE OUTSIDE OF THE PEEL AWAY SHEATH. THE FILTER BASKET WAS FULLY RETRACTED INTO THE DELIVERY SHEATH. THE TIP SOLDER BALL WAS DETACHED AND WAS NOT RETURNED. THE FLUSHING TOOL WAS RETURNED WITH DRIED FLUID VISIBLE IN THE CHAMBER. THERE WAS NO DAMAGE NOTED TO THE FLUSHING TOOL. THE PEEL AWAY SHEATH WAS INTACT AND WAS NOT PEELED. THE TORQUE DEVICE WAS NOT RETURNED. THERE WAS NO OTHER DAMAGE OBSERVED TO THE CATHETER. USING A CONTROL TORQUE DEVICE, THE PEEL AWAY SHEATH WAS PEELED BACK AND THE FILTER BASKET WAS DEPLOYED WITH NO RESISTANCE. THERE WERE NO ANOMALIES OBSERVED WITH THE FILTER BASKET. IT IS UNKNOWN IF THE SOLDER TIP DETACHED DURING THE PROCEDURE OR DURING RETURN SHIPPING. IF THE DEVICE DWELLS IN A SALINE ENVIRONMENT FOR AN EXTENDED PERIOD OF TIME, IT IS POSSIBLE FOR THE SOLDER TIP TO CORRODE AND BECOME DISCONNECTED FROM THE COIL. SALINE IS USED TO PREP THE DEVICE PRIOR TO USE. THE FLUSHING TUBE WAS RETURNED WITH VISIBLE DRIED SALINE INSIDE. NO ROOT CAUSE COULD BE DETERMINED FOR THE OBSERVED DETACHED SOLDER TIP ON THE RETURNED DEVICE. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITIES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: SOLDER TIP DETACHMENT. TIME OF MALFUNCTION: UNKNOWN. SYMPTOMS/AE: NONE. THE DEVICE WAS RECEIVED WITHOUT ANY SUPPORTING INFORMATION REGARDING DEVICE PERFORMANCE OR PATIENT EXPERIENCE. ATTEMPTS TO OBTAIN EVENT INFORMATION WERE UNSUCCESSFUL. DURING DEVICE EVALUATION ON 01/25/2008, SOLDER TIP DETACHMENT WAS FOUND. IT WAS UNKNOWN IF THE DETACHMENT OCCURRED DURING THE PROCEDURE OR DURING SHIPPING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCUNET EMBOLIC PROTECTION SYSTEM NTE ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 7011652

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK