BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARK V PROVIS

    MDR report key: 14196327 · Received April 25, 2022

    Report

    Report Number
    2520313-2022-00018
    Event Type
    Injury
    Date Received
    April 25, 2022
    Date of Event
    February 10, 2022
    Report Date
    May 26, 2022
    Manufacturer
    BAYER MEDICAL CARE INC.
    Product Code
    DXT
    PMA / PMN Number
    K903390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER HAS DELAYED SCHEDULING THE INJECTOR INSPECTION BY BAYER RADIOLOGY FIELD SERVICE. AS WE ARE AWAITING ADDITIONAL INFORMATION, THIS INVESTIGATION REMAINS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THIS REPORTABLE EVENT.

    Additional Manufacturer Narrative · 0

    THE REQUEST BY BAYER MEDICAL CARE FOR A SERVICE CHECK OF THE MEDRAD® MARK V PROVIS INJECTION SYSTEM (SERIAL NUMBER (B)(6)) HAS NOT BEEN APPROVED BY THE CUSTOMER. MULTIPLE DOCUMENTED ATTEMPTS HAVE BEEN MADE TO GAIN SPECIFIC INFORMATION RELATED TO THE REPORTED EVENT; HOWEVER, THESE ATTEMPTS HAVE BEEN UNSUCCESSFUL. BAYER PRODUCT ANALYSIS REVIEWED THE LIMITED INFORMATION THAT WAS PROVIDED AND DETERMINED THAT THERE IS INSUFFICIENT EVIDENCE OF A SYSTEM OR DEVICE MALFUNCTION OR FAILURE TO PERFORM AS INTENDED BY THE DESIGN. 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

    ON (B)(6) 2022, BAYER SERVICE IN (B)(6) WAS CONTACTED BY THE CUSTOMER TO SCHEDULE AN INSPECTION OF THEIR MEDRAD® MARK V PROVIS INJECTION SYSTEM. THE CUSTOMER ALLEGED THAT A (B)(6) FEMALE PATIENT SUFFERED AN ISCHEMIC STROKE ON (B)(6) 2022, FOLLOWING A DIAGNOSTIC CEREBRAL ARTERIOGRAM USING A MEDRAD® PROVIS INJECTION SYSTEM. THE CONTRAST MEDIUM ADMINISTERED AT THE TIME OF THE ARTERIOGRAM WAS VISIPAQUE 270 MANUFACTURED BY GE HEALTHCARE. WE HAVE REQUESTED ADDITIONAL INFORMATION FROM THE CUSTOMER; HOWEVER, NO ADDITIONAL DETAILS HAVE BEEN PROVIDED TO BAYER MEDICAL CARE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198233 MARK V PROVIS ANGIOGRAPHIC INJECTOR DXT BAYER MEDICAL CARE INC. 59353059

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Other