BEUDAMED
    FDA Adverse Event Other Summary report: N

    JETSTREAM NAVITUS

    MDR report key: 2625770 · Received June 13, 2012

    Report

    Report Number
    2183460-2012-00009
    Event Type
    Other
    Date Received
    June 13, 2012
    Date of Event
    May 17, 2012
    Report Date
    June 13, 2012
    Manufacturer
    BAYER INTERVENTIONAL, INC
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT CONSISTS OF JETSTREAM DEVICE FAILURE RESULTING IN A DISTAL EMBOLIZATION DURING A JETSTREAM PROCEDURE. THE PATIENT AGE AND GENDER ARE UNKNOWN AS WELL AS ANY PATIENT HISTORY WHICH IS ALSO UNKNOWN. THE HOSPITAL IS NOT RELEASING ANY INFORMATION CONCERNING THE PATIENT HISTORY OR ADMITTING DIAGNOSIS CITING HIPAA REGULATION. DURING A JETSTREAM PROCEDURE THE JETSTREAM NAVITUS ATHERECTOMY CATHETER STOPPED WORKING RESULTING IN A LOSS OF ASPIRATION IN THE JETSTREAM SYSTEM SUBSEQUENTLY CAUSING A DISTAL EMBOLIZATION IN THE PATIENT. THE PATIENT WAS GIVEN TISSUE PLASMINOGEN ACTIVATOR (TPA) AND BALLOON ANGIOPLASTY WAS PERFORMED. THERE IS NO INFORMATION ON THE PATIENT OUTCOME EXCEPT FOR THE PHYSICIAN STATEMENT THAT THE PROCEDURE HAD A REASONABLE OUTCOME DESPITE THE JETSTREAM DEVICE MALFUNCTION. THIS EVENT IS REPORTABLE SINCE THE PATIENT REQUIRED INTERVENTION CONSISTING OF TPA AND BALLOON ANGIOPLASTY AS A RESULT IN THE DISTAL EMBOLIZATION AND THE ASSOCIATION BETWEEN THE JETSTREAM DEVICE AND THE NOTED EVENT CANNOT BE CONCLUSIVELY RULED OUT.

    Description of Event or Problem · 1

    CATHETER LOST ASPIRATION RESULTING IN DISTAL EMBOLIZATION. ACCOUNT REFUSES TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE PATIENT OR DIAGNOSIS. [PER EMAIL FROM (B)(6) (B)(4) 2012]: DUE TO HIPPA LAW THE ACCOUNT WILL NOT RELEASE ANY INFORMATION CONCERNING PATIENT HISTORY OR ADMITTING DIAGNOSIS. PATIENT OUTCOME WAS DE CAUSED BY LOSS OF ASPIRATION OF THE JETSTREAM. PATIENT WAS GIVEN TPA AND BALLOON ANGIOPLASTY WAS PERFORMED. PHYSICIAN WAS UPSET THAT THE JETSTREAM FAILED TO WORK PROPERLY BUT THAT HE HAD A REASONABLE OUTCOME DESPITE THE JETSTREAM. THE PROCEDURE DETAILS THAT CAUSED THE EVENT WERE THAT THE JETSTREAM DID NOT WORK AND QUIT ASPIRATING. THAT IS ALL OF THE INFORMATION I HAVE. PLEASE FEEL FREE TO REACH OUT TO THE PHYSICIAN AT THE PHONE NUMBER I LISTED ON THE COMPLAINT FORM IF YOU REQUIRE ANY ADDITIONAL INFORMATION. I WAS NOT AT THE CASE AND CAN'T PROVIDE ANY...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JETSTREAM NAVITUS JETSTREAM NAVITUS MCW BAYER INTERVENTIONAL, INC NAVITUS 120223

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention