BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFORMA ANGIOGRAPHIC CATHETERS

    MDR report key: 2080421 · Received April 22, 2011

    Report

    Report Number
    1628221-2011-00025
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 28, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K943739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. THE PIGTAIL STRAIGHTENER IS DESIGNED TO STRAIGHTEN OUT THE PIGTAIL CURVE PRIOR TO LOADING THE CATHETER ONTO A GUIDEWIRE. THE STRAIGHTENER HAS A SPLIT IN IT SO THAT ONCE THE CURVE IS STRAIGHTENED AND THE CATHETER LOADED ONTO THE GUIDEWIRE, THE STRAIGHTENER CAN BE PULLED OFF OF THE CATHETER. THIS EVENT IS BELIEVED TO BE ISOLATED. NO DEVICE FAILURE. USER ERROR CAUSED EVENT. EVALUATION, METHOD: DEVICE HISTORY RECORD WAS REVIEWED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A STENTING PROCEDURE, THE PIGTAIL STRAIGHTENER USED ON THE CATHETER WAS INSERTED INTO THE PT'S BODY. A SNARE WAS USED TO SAFELY REMOVE THE DEVICE FROM THE PT. THE DEVICE WAS DISCARDED AT THE HOSPITAL. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFORMA ANGIOGRAPHIC CATHETERS CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. E185973

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SNARE| 14FR SHEATH