BEUDAMED
    FDA Adverse Event Other Summary report: N

    JETSTREAM NAVITUS L

    MDR report key: 2612721 · Received June 1, 2012

    Report

    Report Number
    2183460-2012-00004
    Event Type
    Other
    Date Received
    June 1, 2012
    Date of Event
    May 4, 2012
    Report Date
    June 1, 2012
    Manufacturer
    BAYER INTERVENTIONAL INC
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT CONSIST OF PT REQUIRING PLATELETS AND BLOOD TRANSFUSION POST JETSTREAM PROCEDURE. THE PT IS A MALE OF UNK AGE WHO PRESENTED FOR ATHERECTOMY OF THE COMMON FEMORAL ARTERY (CFA). NO ADD'L PT INFO IS AVAILABLE. THE PHYSICIAN PERFORMED AN ATHERECTOMY OF THE CFA USING A JETSTREAM NAVITUS L DEVICE. DURING THE PROCEDURE 3 PASSES WERE MADE WITH THE BLADES DOWN AND ANOTHER 3 - 4 PASSES WERE MADE WITH THE BLADES UP WITH A TOTAL RUN TIME OF 4 MINUTES, 46 SECONDS. POST JETSTREAM TREATMENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS DONE WITH A 7 X 30 BALLOON. ANGIOGRAPHIC RESULTS WERE DEEMED SUCCESSFUL BY THE PHYSICIAN. POST PROCEDURE (UNK TIME POST PROCEDURE) THE PT DEVELOPED A FEVER, HEMATURIA, AND A DROP IN HEMOGLOBIN (HGB). THE PT RECEIVED PLATELETS AND BLOOD TRANSFUSION. HEMATURIA RESOLVED AFTER 48 HOURS. SINCE THE PT REQUIRED INTERVENTION CONSISTING OF PLATELETS AND BLOOD TRANSFUSION AS A RESULT IN THE DROP OF HGB AND THE ASSOCIATION BETWEEN THE JETSTREAM DEVICE AND THE NOTED EVENTS CANNOT BE CONCLUSIVELY RULED OUT THIS EVENT IS CONSIDERED REPORTABLE.

    Description of Event or Problem · 1

    DR (B)(6) PERFORMED AN ATHERECTOMY OF CFA USING THE NAVITUS L DEVICE. THREE PASSES WERE MADE BLADES DOWN AND ANOTHER 3 - 4 BLADES UP WITH A TOTAL RUN TIME OF 4:46. POST JS PTA WAS DONE WITH 7 X 30 BALLOON AND ANGIOGRAPHIC RESULT WAS DEEMED SUCCESSFUL BY PHYSICIAN. SUBSEQUENTLY, THE PT DEVELOPED A FEVER, HEMATURIA AND A DROP IN HGB. PT RECEIVED PLATELETS AND BLOOD TRANSFUSION. HEMATURIA RESOLVED AFTER 48 HOURS. NO ADD'L PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JETSTREAM NAVITUS L JETSTREAM NAVITUS L MCW BAYER INTERVENTIONAL INC NAVITUS L 120326

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention