BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARK V PROVIS

    MDR report key: 7004543 · Received November 6, 2017

    Report

    Report Number
    2520313-2017-00070
    Event Type
    Injury
    Date Received
    November 6, 2017
    Report Date
    November 7, 2017
    Manufacturer
    BAYER MEDICAL CARE, INC.
    Product Code
    DXT
    PMA / PMN Number
    K903390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL MDR WAS SUBMITTED WITHOUT INITIAL REPORTER INFORMATION INCLUDED. THIS REPORT PROVIDES THAT CORRECTED INFORMATION.

    Additional Manufacturer Narrative · 1

    THE SITE REQUESTED ADDITIONAL TRAINING FOR THEIR STAFF. TRAINING WAS PROVIDED BY A BAYER CLINICAL SUPPORT SPECIALIST ON (B)(6) 2017. EFFORTS TO OBTAIN ADDITIONAL INFORMATION ABOUT THE PATIENT'S CURRENT CONDITION AS WELL AS THE EQUIPMENT SERIAL NUMBER FROM THE SITE HAVE BEEN UNSUCCESSFUL. OFFERS TO THE SITE TO PERFORM A BAYER SYSTEM SERVICE CHECK OF THE INJECTOR HAVE GONE UNANSWERED. A FOLLOW UP REPORT WILL BE SUBMITTED IF ANY FURTHER INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE SITE REPORTED THE FOLLOWING INFORMATION TO A BAYER CLINICAL IMAGING SERVICES MANAGER: A PATIENT EXPERIENCED AN AIR INJECTION WHILE CONNECTED TO A MARK V PROVIS INJECTOR (SERIAL NUMBER UNKNOWN). WE WERE INFORMED THAT THE PATIENT SUFFERED A STROKE DURING THE PROCEDURE. THE DIRECTOR OF RISK MANAGEMENT OF THE HEALTHCARE SYSTEM RETURNED OUR PHONE CALL ON (B)(6) 2017, IN RESPONSE TO OUR INFORMATION GATHERING EFFORT. DURING THE BRIEF PHONE CALL WITH SITE RISK MANAGEMENT, THEY STATED THAT THERE WAS NO EQUIPMENT FAULT AND ACKNOWLEDGED THAT THE LINE WAS NOT PURGED OF AIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783902 MARK V PROVIS ANGIOGRAPHIC INJECTOR DXT BAYER MEDICAL CARE, INC. 59938669

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L