BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARIFIX

    MDR report key: 9383045 · Received November 27, 2019

    Report

    Report Number
    9383045
    Event Type
    Malfunction
    Date Received
    November 27, 2019
    Date of Event
    October 16, 2018
    Report Date
    November 10, 2019
    Manufacturer
    ARRINEX, INC.
    Product Code
    GEH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CLARIFIX BALLON BROKE WHILE BEING USED IN THE PATIENT. PRODUCT WAS IMMEDIATELY REMOVED FROM THE FIELD. ANOTHER CLARIFIX WAS OPENED TO PROCEED WITH THE PROCEDURE. THE CLARIFIX BALLOON WAS DAMAGED INTRA-OPERATIVELY DURING THE CRYOABLATION PORTION OF THE PROCEDURE. CLARIFIX REFERENCE #(B)(4), LOT #19071001, EXPIRATION DATE 07/10/2020. CLARIFIX AND PACKAGING SEQUESTERED UNTIL RELEASE BY RISK MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1178150 CLARIFIX UNIT, CRYOSURGICAL, ACCESSORIES GEH ARRINEX, INC. CFX-0001 19071001

    Patients

    Seq Age Sex Outcome Treatment
    1 22995 DA