BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETAP(TM) CARDIOVASCULAR PATCH

    MDR report key: 5295746 · Received December 14, 2015

    Report

    Report Number
    3009718407-2015-00001
    Event Type
    Malfunction
    Date Received
    December 14, 2015
    Date of Event
    October 26, 2015
    Report Date
    December 7, 2015
    Manufacturer
    SOLINAS MEDICAL INC.
    Product Code
    DXZ
    PMA / PMN Number
    K122105
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A ROUTINE DECLOTTING PROCEDURE A PORTION OF THE NITINOL FRAMEWORK OF THE DEVICE DETACHED AND WAS REMOVED WITH THE DECLOTTING DEVICE. THE LOOSE PORTION OF THE DEVICE WAS COMPLETELY REMOVED AND THERE WAS NO REPORTED HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825253 RETAP(TM) CARDIOVASCULAR PATCH CARDIOVASCULAR PATCH DXZ SOLINAS MEDICAL INC. FG0005-01 15031904

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR