BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORPATH GRX

    MDR report key: 12795922 · Received November 11, 2021

    Report

    Report Number
    3007822508-2021-00004
    Event Type
    Injury
    Date Received
    November 11, 2021
    Date of Event
    October 19, 2021
    Report Date
    November 10, 2021
    Manufacturer
    CORINDUS INC
    Product Code
    DXX
    PMA / PMN Number
    K173806
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PHYSICIAN INDICATED THAT THERE WAS NO FINE ADJUSTMENT FEATURE FOR THE GUIDE CATHETER. THE PHYSICIAN WAS NOTIFIED THAT THIS FEATURE DOES EXIST. THE TRAINING MATERIAL PROVIDED TO THE PHYSICIAN HAS THE REQUESTED FEATURE ON THE SYSTEM AND THE PHYSICIAN WAS MADE AWARE OF THE FEATURE. NO DEVICE WAS RETURNED AND THE SYSTEM IS FUNCTIONAL.

    Description of Event or Problem · 0

    GUIDE CATHETER INDUCED DISSECTION WITH ACUTE LAD CLOSURE. USER FEEDBACK: THERE SHOULD BE AN OPTION TO SELECT LOWER AMPLITUDE MOVEMENTS OF THE GUIDE CATHETER JOYSTICK. THE JOYSTICK MOVEMENTS ARE TOO COARSE AND THERE SHOULD BE A FINER CONTROL OPTION. (ANALOGOUS TO WIRE CONTROL, WHICH CAN BE PERFORMED BY TOUCHSCREEN ARROWS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1690510 CORPATH GRX CORPATH GRX SYSTEM DXX CORINDUS INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention