BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOLCANO CORE MOBILE SYSTEM MEDICAL EQUIPMENT

    MDR report key: 18162666 · Received November 17, 2023

    Report

    Report Number
    3008363989-2023-00058
    Event Type
    Injury
    Date Received
    November 17, 2023
    Date of Event
    October 19, 2023
    Report Date
    December 14, 2023
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    IYO
    PMA / PMN Number
    K173860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER¿S POLICY. BLOCKS A2-A5: NO INFORMATION AVAILABLE. BLOCKS B6-B7: NO INFORMATION AVAILABLE. BLOCK C: NOT APPLICABLE FOR THIS DEVICE. BLOCKS D4 & D6 & D7: NOT APPLICABLE FOR THIS DEVICE. BLOCKS H3 & H6: THE FIELD SERVICE ENGINEER REPLACED THE FFM PIM MODULE AND THE EXTENDER CABLE ON THE CORE MOBILE SYSTEM AT THE CUSTOMER SITE. THE SYSTEM MET SPECIFICATION FOR THE PERFORMED SERVICE AND RETURNED FOR USE. BLOCKS H7 & H9: DO NOT APPLY TO THIS SUBMISSION. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO AN ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.

    Additional Manufacturer Narrative · 0

    BLOCK H3: THE CORE MOBILE FFR PIMMETTE WAS RETURNED FOR EVALUATION WITHOUT THE EXTENDER CABLE (FFR PIMMETTE AND EXTENDER CABLE REPLACED AT FACILITY SITE). VISUAL INSPECTION OF THE FFR PIMMETTE FOUND NO DAMAGE OBSERVED. DURING FUNCTIONAL TESTING, THE FFR PIMMETTE WAS CONNECTED TO THE LAB SYSTEM AND WAS ABLE TO BE RECOGNIZED BY THE SYSTEM. THE DEVICE FUNCTIONED AS EXPECTED WITH A PRESSURE WIRE SIMULATOR, EVEN UPON MANIPULATION OF THE CABLE CONNECTION AND DISCONNECTION/RECONNECTION OF THE FFR PIMMETTE TO THE SYSTEM. BLOCK H6: BASED ON THE RETURNED DEVICE EVALUATION, THE PROBABLE CAUSE OF THE REPORTED FAILURE COULD NOT BE CONCLUSIVELY DETERMINED SINCE THE DEVICE FUNCTIONED AS INTENDED. HOWEVER, THE EXTENDER CABLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE CAUSE OF THE REPORTED FAILURE COULD NOT BE ESTABLISHED. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO AN ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CORE MOBILE SYSTEM WAS USED IN A NON-EMERGENCY CORONARY LEFT HEART CATHETERIZATION PROCEDURE. THE PATIENT WAS PREPPED WITH LOCAL ANESTHESIA, AND IN THE MIDDLE OF THE PROCEDURE, THE SYSTEM MALFUNCTIONED. THE WAVEFORMS DID NOT OVERLAP AS EXPECTED; THEREFORE, THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. THE PLAN WAS TO SEND THE PATIENT TO ANOTHER HOSPITAL FOR TREATMENT. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING REPORTED BECAUSE THE PATIENT WAS FULLY PREPPED, AND THE SYSTEM STOPPED MID PROCEDURE. THIS RESULTED IN A DELAY OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722031 VOLCANO CORE MOBILE SYSTEM MEDICAL EQUIPMENT SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO VOLCANO CORPORATION 400-0100.01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other UNK MFG AND SIZE: GUIDE CATHETER| UNK MFG AND SIZE: GUIDE WIRE| UNK MFG AND SIZE: INTRODUCER SHEATH