BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 3396024 · Received September 13, 2013

    Report

    Report Number
    2529252-2013-00008
    Event Type
    Malfunction
    Date Received
    September 13, 2013
    Date of Event
    August 1, 2013
    Report Date
    August 15, 2013
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.- MALVERN
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MERIT MEDICAL SYSTEMS, INC.- (B)(4) DIVISION HAS INITIATED AN INVESTIGATION AND IT IS CURRENTLY IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED: "13 FR SHEATH SIDE ARM FELL OFF WHILE IN ARTERY. PT LOST SMALL AMT OF BLOOD. WHILE CHANGING SHEATH LOST WIRE ACCESS SO HAD TO CHANGE TO CONTRA SIDE..."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462956 NONE DYB MERIT MEDICAL SYSTEMS, INC.- MALVERN KIT-030-01 S39644X1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 62205/C-14| IMPELLA LP2.5 PUMP