BEUDAMED
    FDA Adverse Event Death Summary report: N

    THROMCAT THROMECTOMY CATHETER

    MDR report key: 1918030 · Received December 2, 2010

    Report

    Report Number
    1721279-2009-00022
    Event Type
    Death
    Date Received
    December 2, 2010
    Date of Event
    March 9, 2009
    Report Date
    March 23, 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). THE PT PRESENTED TO THE HOSPITAL COMPLAINING OF CHEST PAIN FOR 3 DAYS. AN EKG REVEALED ST ELEVATION THAT SUGGESTED A MYOCARDIAL INFARCTION THAT HAD OCCURRED WITHIN THE LAST 3 HRS UP TO 2 DAYS AGO. THE PT WAS FOUND TO HAVE TWO-VESSEL DISEASE WITH OCCLUSION OF THE PROXIMAL LAD JUST AT THE ORIGIN FROM THE LEFT MAIN. ASPECT OF A MASSIVE THROMBUS WITH MODERATE CALCIFICATION OF LAD INDICATING THROMBUS ASPIRATION AS THE PRIMARY APPROACH. THE THROMCAT DEVICE WAS CHOSEN, BUT WAS UNABLE TO ADVANCE THROUGH STENOSIS. PRE-DILATATION WAS DONE; THE LAST ATTEMPT TO ADVANCE THE THROMCAT WAS UNSUCCESSFUL EVEN WITH MODERATE PRESSURE APPLIED. ANGIOGRAM SHOWED A PERFORATION. A COVERED STENT WAS PLACED INTO THE LAD BUT FAILED. THE STENT COULD NOT BE WITHDRAWN AND WAS LOST INTO THE MAIN STEM. PT WAS TRANSFERRED TO THE OPERATING ROOM FOR EMERGENT SURGERY. PT ULTIMATELY DID NOT SURVIVE THE SURGERY. THERE WAS NO ALLEGED DEFECT OR MALFUNCTION OF THE THROMCAT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THROMCAT THROMECTOMY CATHETER THROMCAT MCW SPECTRANETICS CORP 63000-02 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death