BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THROMCAT XT THROMECTOMY CATHETER

    MDR report key: 1917406 · Received December 2, 2010

    Report

    Report Number
    1721279-2010-00075
    Event Type
    Injury
    Date Received
    December 2, 2010
    Date of Event
    June 30, 2009
    Report Date
    June 30, 2009
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MCW
    PMA / PMN Number
    K060016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO DEVICES RETURNED FOR ENGINEERING ANALYSIS. THE RESULTS OF AN INTERNAL DEVICE LOT HISTORY REVIEW FOUND NO ISSUES OR NON-CONFORMANCES. (B)(4).

    Description of Event or Problem · 1

    THE REASON FOR THIS MDR IS TO REPORT AN ADVERSE EVENT THAT OCCURRED IN (B)(6). A THROMCAT XT THROMBECTOMY CATHETER WAS USED IN RCX TO TREAT TOTAL OCCLUSION WITH THROMBUS, AFTER FIRST RUN, A DISSECTION WAS OBSERVED IN THE AREA OF THE STENOSIS. THE DISSECTION WAS REPAIRED AND THE PT RECOVERED FROM THE PROCEDURE SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THROMCAT XT THROMECTOMY CATHETER THROMCAT XT MCW SPECTRANETICS CORP. 63010-02 83068

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening| R