BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFORMA ANGIOGRAPHIC CARDIOLOGY CATHETER

    MDR report key: 4469089 · Received January 28, 2015

    Report

    Report Number
    1628221-2015-00002
    Event Type
    Injury
    Date Received
    January 28, 2015
    Date of Event
    January 6, 2015
    Report Date
    January 9, 2015
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K943739
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: NO DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. BECAUSE THE UNIT WAS NOT RETURNED, THE ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO EXCEPTION DOCUMENTS WERE FOUND. ALL IN-PROCESS TESTING DATA WAS REVIEWED AND FOUND TO BE IN SPECIFICATION. THE COMPLAINT DATABASE WAS REVIEWED AND ONE SIMILAR COMPLAINT FOR THIS LOT NUMBER WAS FOUND. IF THE DEVICE IS RETURNED IN THE FUTURE THIS INVESTIGATION WILL BE REOPENED AND A FOLLOW UP SUBMITTED.

    Description of Event or Problem · 1

    HOLD CJC 2/2/2015THE PHYSICIAN REPORTED THAT DURING A DIAGNOSTIC CORONARY ANGIOGRAPHY, THE COMMON TRUNK OF THE LEFT CORONARY ARTERY BECAME LOCALLY DISSECTED. THE PT WAS TRANSFERRED TO SURGERY TO RESOLVE THE DISSECTION. THE PHYSICIAN STATED THAT THE CATHETER IS TOO AGGRESSIVE AND HAD BAD TORQUE. THE PT IS DOING WELL AND NO FURTHER HARM OR INJURY TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65150 PERFORMA ANGIOGRAPHIC CARDIOLOGY CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. I685723

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R