BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 3864330 · Received June 10, 2014

    Report

    Report Number
    2024168-2014-03716
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION AND THE REPORTED HANDLE DAMAGE WAS CONFIRMED. BASED ON VISUAL ANALYSIS 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 THIS COMPLAINT. A QUERY OF THE COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER DEVICE PREPARATION AND WHILE ATTEMPTING TO BACKLOAD THE DEVICE ONTO THE GUIDE WIRE THE SHAFT AND SLIDER HANDLE WAS NOTED TO HAVE SEPARATED INTO TWO PIECES. THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INTERACTION. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339498 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 4013161

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR