BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORMA ANGIOGRAPHIC CATHETERS

    MDR report key: 3050199 · Received April 5, 2013

    Report

    Report Number
    1628221-2013-00003
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K943739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. ATTEMPTS TO GATHER ADDITIONAL INFORMATION ON (B)(6) 2013 HAVE NOT BEEN SUCCESSFUL. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE CATHETER BROKE DURING AN ANGIOGRAPHIC PROCEDURE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE USER. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141706 PERFORMA ANGIOGRAPHIC CATHETERS CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. E160749

    Patients

    Seq Age Sex Outcome Treatment
    1