BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1903841 · Received November 20, 2010

    Report

    Report Number
    3004742046-2010-00547
    Event Type
    Malfunction
    Date Received
    November 20, 2010
    Report Date
    October 13, 2010
    Manufacturer
    AV-TEMECULA
    Product Code
    NIM
    PMA / PMN Number
    P040038
    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. EVALUATION SUMMARY: EVALUATION OF THE RETURNED PRODUCT DID NOT CONFIRM THE REPORTED KINK; HOWEVER, THE DISTAL SHEATH WAS SEPARATED 1 CM DISTAL TO THE GUIDEWIRE EXIT NOTCH. THE SHEATH WAS STILL INTACT VIA ITS ATTACHMENT TO THE SUPPORT WIRE. IT IS POSSIBLE THAT THIS DAMAGE WAS WHAT WAS INTENDED TO BE REPORTED. ADDITIONAL CLARIFICATION WAS REQUESTED; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE. SEPARATIONS CAN BE A RESULT OF, BUT NOT LIMITED TO, DEVICE INTERACTIONS, TORTUOUS ANATOMY, PHYSICIAN TECHNIQUE, AND/OR HANDLING. TO ENSURE THIS IS NOT A RESULT OF A MANUFACTURING DEFICIENCY, DEVICES ARE 100% VISUALLY INSPECTED ONLINE AND A SAMPLE OF EACH LOT IS FULLY FUNCTIONALLY TESTED. IN THIS CASE, AS THIS DAMAGE WAS NOTED DURING UNPACKAGING, IT IS POSSIBLE THAT THIS DAMAGE IS RELATED TO MANUFACTURING. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS REPORT. IN THIS CASE, A DEFINITIVE CAUSE FOR THE NOTED SEPARATION CANNOT BE DETERMINED; HOWEVER, MANUFACTURING WILL BE NOTIFIED FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION, WHEN REMOVING FROM PACKAGING, THE DISTAL SHAFT WAS NOTED TO BE KINKED. THE DEVICE WAS NOT USED ON THE PATIENT. ANOTHER XACT WAS SUCCESSFULLY USED. RETURNED DEVICE ANALYSIS NOTED A DISTAL SHAFT (SHEATH) SEPARATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA 0080361

    Patients

    Seq Age Sex Outcome Treatment
    1