BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX ACCUNET EMBOLIC PROTECTION SYSTEM

    MDR report key: 2739752 · Received September 11, 2012

    Report

    Report Number
    2024168-2012-05731
    Event Type
    Malfunction
    Date Received
    September 11, 2012
    Date of Event
    August 17, 2012
    Report Date
    August 20, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K081549
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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: THE DEVICE WAS RETURNED FOR ANALYSIS. THE OPEN PACKAGING AND MISASSEMBLED DEVICE WERE ABLE TO BE CONFIRMED. BASED ON A VISUAL INSPECTION 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 THE REPORTED EVENT. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT-HANDLING DATABASE FROM THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN UNPACKING THE 3-IN-1 RX ACCUNET EMBOLIC PROTECTION SYSTEM FROM ITS PACKAGING, IT APPEARED THAT ALL OF THE PACKAGING (BOTH OUTER AND INNER) HAD ALREADY BEEN OPENED (WITH THE SEAL COMPROMISED) AND THE FILTER WAS EXPOSED. THE FILTER WAS DESCRIBED AS NOT BEING PROPERLY HOUSED INSIDE OF THE PURPLE FLUSHER, AS THE FILTER APPEARED TO HAVE BEEN PULLED OUT. THE SITE INDICATED THAT THE DEVICE WAS RECEIVED IN THIS CONDITION. THE DEVICE WAS NOT USED IN THE PATIENT AND THERE WAS NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. ANOTHER ACCUNET DEVICE WAS USED IN COMPLETING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCUNET EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA-CT 2061961

    Patients

    Seq Age Sex Outcome Treatment
    1