BEUDAMED
    FDA Adverse Event Death Summary report: N

    MARK V PROVIS

    MDR report key: 2018706 · Received February 10, 2011

    Report

    Report Number
    2520313-2011-00001
    Event Type
    Death
    Date Received
    February 10, 2011
    Date of Event
    January 13, 2011
    Report Date
    February 10, 2011
    Manufacturer
    MEDRAD, INC.
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE RISK MGR INDICATED ON THE (B)(4), A SYSTEM SERVICE CHECK OF THE PROVIS INJECTOR, PERFORMED ON (B)(6) 2011, VERIFIED THAT THE INJECTOR WAS OPERATING WITHIN MEDARD SPECIFICATIONS. THE INJECTOR IS CURRENTLY BEING USED WITHOUT ISSUE. THE SITE DID NOT RETAIN THE DISPOSABLES THAT WERE IN USE DURING THE REPORTED EVENT; THEREFORE, NO FURTHER INVESTIGATION OF THE DISPOSABLES IS POSSIBLE. ADD'L APPLICATIONS TRAINING WAS OFFERED TO THE CUSTOMER. WE ARE AWAITING THEIR RESPONSE. (B)(6).

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO A MEDRAD SERVICE REP: THE SITE REPORTED THAT THERE WAS AN AIR INJECTION DURING A PROCEDURE IN THE OPERATING ROOM WHILE THE PROVIS INJECTOR WAS IN USE. IT WAS REPORTED BY THE SITE THAT THIS EVENT WAS MOST LIKELY CAUSED BY OPERATOR ERROR. ON (B)(6) 2011, THE HOSPITAL'S RISK MANAGEMENT GROUP FORWARDED A COPY TO MEDRAD OF THE MEDWATCH REPORT THAT THEY SUBMITTED TO THE FDA. (B)(4). PT IS AN (B)(6) FEMALE WHO ON (B)(6) 2011 UNDERWENT A TRAN APICAL TRANSCATHETER AORTIC VALVE IMPLANTATION. DURING THE PROCEDURE, AN AIR EMBOLUS WAS NOTED IN THE AORTA. PT IMMEDIATELY EXPERIENCED A CARDIAC ARREST REQUIRING EMERGENT CARDIOPULMONARY RESUSCITATION. A HEAD CT SCAN FOLLOWING THIS EVENT CONFIRMED SIGNIFICANT BRAIN INJURY WITH HERNIATION. HYPERBARIC AND HYPERTHERMIA THERAPY WAS INITIATED. AFTER FURTHER NEUROLOGICAL EVALUATION, THE PT WAS DEEMED TO HAVE IRREVERSIBLE BRAIN INJURY. CARE WAS WITHDRAWN PER FAMILY'S REQUEST. PT EXPIRED ON (B)(6) 2011. ON THE EVENING ON (B)(6) 2011, MEDRAD SERVICE TECHNICIAN (B)(4) INSPECTED THE POWER INJECTOR AND ALSO IN ATTENDANCES WAS (B)(6). PER MEDRAD SERVICE REPORT, NO MECHANICAL DYSFUNCTION WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARK V PROVIS ANGIOGRAPHIC INJECTOR DXT MEDRAD, INC. PPD-110 60 507

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death