BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDRAD ANGIOGRAPHIC/CT INJECTOR

    MDR report key: 21584442 · Received March 12, 2025

    Report

    Report Number
    2520313-2025-00009
    Event Type
    Injury
    Date Received
    March 12, 2025
    Date of Event
    February 7, 2025
    Report Date
    March 12, 2025
    Manufacturer
    BAYER MEDICAL CARE INC
    Product Code
    DXT
    UDI-DI
    00616258009360
    PMA / PMN Number
    K113133
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SYSTEM SERVICE CHECK OF THE MEDRAD® MARK 7 ARTERION INJECTION SYSTEM (SN (B)(6)) WAS PERFORMED ON (B)(6) 2025, WHICH CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN BAYER SPECIFICATIONS. THE DISPOSABLES THAT WERE IN USE DURING THE PROCEDURE WERE DISCARDED BY THE SITE; THEREFORE, THEY ARE NOT AVAILABLE FOR EVALUATION. THE CUSTOMER WAS UNABLE TO PROVIDE THE LOT NUMBER OF THE DISPOSABLES USED DURING THE PROCEDURE; THEREFORE, TESTING OF RETAINED SAMPLES WAS NOT POSSIBLE. THE OFFER OF ADDITIONAL CLINICAL APPLICATIONS TRAINING WAS ACCEPTED BY THE CUSTOMER AND IS BEING PROVIDED BY THE CLINICAL PERFORMANCE CENTER. THE MEDRAD® MARK 7 ARTERION INJECTION SYSTEM OPERATION MANUAL CAUTIONS THE USER AS FOLLOWS: PURGE ALL AIR FROM SYRINGE AND DISPOSABLES BEFORE CONNECTING OR INJECTING TO PATIENT. BEFORE ARMING, THE SYSTEM PROMPTS THE OPERATOR TO CONFIRM THAT AIR HAS BEEN PURGED FROM THE SYRINGE AND DISPOSABLE SET. ONCE IN THE ARMED STATE, THE SYSTEM WILL NOT PROMPT THE OPERATOR TO CHECK FOR AIR UNLESS THE OPERATOR PERFORMS AN ACTION THAT MAY INTRODUCE AIR. IT IS THE OPERATOR'S RESPONSIBILITY TO SUCCESSFULLY PURGE ALL AIR FROM THE SYSTEM. THE PURGED AIR CONFIRMATION ICON DISPLAYS ON THE DISPLAY CONTROL UNIT AFTER THE OPERATOR CONFIRMS AIR IS EXPELLED FROM SYRINGE AND DISPOSABLE SET. THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.

    Description of Event or Problem · 0

    BAYER MEDICAL CARE INC. WAS INFORMED THAT 65-YEAR-OLD MALE HAD EXPERIENCED LEFT-SIDED WEAKNESS AND A DROP IN OXYGEN SATURATION LEVELS DURING A LEFT HEART CATHETERIZATION WHILE CONNECTED TO A MEDRAD® MARK 7 ARTERION INJECTION SYSTEM (SN (B)(6)). MEDICAL STAFF SUSPECTED AN ALLEGED AIR INJECTION OCCURRED WHILE THE INJECTOR WAS CONNECTED TO THE PATIENT; HOWEVER, THIS WAS NOT CONFIRMED ON THE FLUOROSCOPIC IMAGES FROM THE PROCEDURE. FOLLOWING THE DEVELOPMENT OF THE REPORTED SYMPTOMS, A STROKE CODE WAS CALLED, THE PATIENT WAS GIVEN MEDICATION, A TEMPORARY PACEMAKER, AND WAS TAKEN TO THE RADIOLOGY DEPARTMENT WHERE A CT OF THE HEAD WAS PERFORMED, AND AIR WAS VISUALIZED ON THE DISPLAYED IMAGES. THE AMOUNT OF AIR WAS NOT QUANTIFIED. THE PATIENT IS IN THE ICU AND IS REPORTED AS BEING STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1434182 MEDRAD ANGIOGRAPHIC/CT INJECTOR ANGIOGRAPHIC/CT INJECTOR DXT BAYER MEDICAL CARE INC 60726793 00616258009360

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Other