BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRELUDE SHEATH INTRODUCER

    MDR report key: 3030849 · Received March 28, 2013

    Report

    Report Number
    1721504-2013-00071
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DRE
    PMA / PMN Number
    K050962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE EVALUATION HAS NOT BEEN COMPLETED. THE USER DID NOT SPECIFY IF THIS WAS THE INITIAL USE OF THE DEVICE. THE DEVICE HISTORY RECORD AND COMPLAINT DATABASE COULD NOT BE REVIEWED AS NO LOT NUMBER WAS PROVIDED. ATTEMPTS WERE MADE ON (B)(4) 2013 (TWICE) AND (B)(4) 2013 TO OBTAIN ADDITIONAL INFORMATION WITH NO SUCCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT WHILE BACKING THE SHEATH OUT OF THE PT, IT BROKE NEAR THE HUB. NO FURTHER INFORMATION WAS PROVIDED. THE USER DID NOT PROVIDE A LOT NUMBER. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129538 PRELUDE SHEATH INTRODUCER DILATOR, VESSEL, FOR PERCUTANEOUS CATH DRE MERIT MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1