BEUDAMED
    FDA Adverse Event Death Summary report: N

    MARK V PROVIS

    MDR report key: 7131068 · Received December 19, 2017

    Report

    Report Number
    2520313-2017-00084
    Event Type
    Death
    Date Received
    December 19, 2017
    Date of Event
    November 29, 2017
    Report Date
    April 23, 2018
    Manufacturer
    BAYER MEDICAL CARE, INC.
    Product Code
    DXT
    PMA / PMN Number
    K903390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISPOSABLES THAT WERE IN USE DURING THE PROCEDURE WERE DISCARDED BY THE SITE. THE SITE WAS UNABLE TO PROVIDE THE LOT NUMBER OF THE DISPOSABLES; THEREFORE, TESTING OF RETAINED SAMPLES WAS NOT CONDUCTED. THE OFFER OF AN INJECTOR CHECK WAS DECLINED BY THE CUSTOMER WHO ADMITTED THAT THIS ISSUE WAS CAUSED BY USER ERROR. MULTIPLE DOCUMENTED ATTEMPTS HAVE BEEN MADE TO GAIN SPECIFIC INFORMATION RELATED TO THE REPORTED EVENT; HOWEVER, THESE ATTEMPTS HAVE BEEN UNSUCCESSFUL. THE OFFER OF ADDITIONAL CLINICAL APPLICATIONS TRAINING HAS NOT BEEN ACCEPTED BY THE CUSTOMER. THE SITE CONTINUES TO USE THE PROVIS INJECTION SYSTEM AFTER THE REPORTED EVENT. NO FURTHER ISSUES WERE REPORTED. THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR (2520313-2017-00084) DATED DECEMBER 19, 2017 WAS SUBMITTED WITH AN INCORRECT MATERIAL NUMBER OF THE INJECTOR. THE CORRECT MATERIAL NUMBER IS 59353113.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE FOLLOWING TO BAYER: A CEREBRAL ANGIOGRAM WITH MECHANICAL THROMBECTOMY WAS BEING PERFORMED ON A (B)(6) FEMALE PATIENT WHO PRESENTED WITH AN ACUTE CEREBROVASCULAR ACCIDENT. A GUIDE CATHETER WAS ADVANCED TO THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). AFTER SEVERAL PASSES WITH A THROMBECTOMY DEVICE, BLOOD FLOW HAD BEEN RESTORED. THE PHYSICIAN THEN PROCEEDED TO USE THE MARK V PROVIS INJECTION SYSTEM (SN (B)(4)) TO PERFORM THE CEREBRAL ANGIOGRAM. THE PHYSICIAN CONNECTED THE INJECTOR TUBING TO THE PATIENT AND REQUESTED THE LINE TO BE PURGED. THE SITE HAD REPORTED TO BAYER THAT "THE LINE WAS NOT PURGED AT ALL AND THE PURGING THAT DID HAPPEN WASN'T ENOUGH TO REACH THE END OF THE TUBING." THE SITE PROCEEDED TO ARM THE INJECTOR AND PERFORM THE ANGIOGRAM STUDY. THE SITE REPORTED THAT THE AIR THAT WAS IN THE TUBING WAS INJECTED INTO THE PATIENT'S ARTERY. A CT SCAN OF THE PATIENT'S BRAIN WAS PERFORMED; HOWEVER, THE RESULTS WERE NOT PROVIDED TO BAYER. SOMETIME LATER, THE PATIENT PASSED AWAY. AN AUTOPSY WAS NOT REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907491 MARK V PROVIS ANGIOGRAPHIC INJECTOR DXT BAYER MEDICAL CARE, INC. 58748440

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death