BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 2400682 · Received January 6, 2012

    Report

    Report Number
    2024168-2012-00062
    Event Type
    Malfunction
    Date Received
    January 6, 2012
    Date of Event
    October 4, 2011
    Report Date
    October 5, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ANALYSIS OF THE RETURNED DEVICE CONFIRMED A MISLABELING DISCREPANCY/PRODUCT MIX-UP.

    Description of Event or Problem · 1

    THE RX VOYAGER WAS RETURNED FOR ANALYSIS, AND IT WAS NOTED THAT THE CHIPBOARD BOX WAS MARKED WITH THE PART/LOT # 1011394-15/1051661, BUT THE DEVICE THAT WAS IN THE BOX WAS PART/LOT # 1011392-12/1051861. IT WAS CONFIRMED WITH THE ACCOUNT MANAGER THAT THE CORRECT PART WAS RETURNED FROM THE ACCOUNT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER RX CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 1051661

    Patients

    Seq Age Sex Outcome Treatment
    1