BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THROMCAT THROMBECTOMY CATHETER SYSTEM

    MDR report key: 1994357 · Received January 14, 2011

    Report

    Report Number
    1721279-2008-00035
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    May 20, 2008
    Report Date
    June 13, 2008
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MCW
    PMA / PMN Number
    K060016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY FILES FOR PN 63000-0, LN 60802 AND PN 4119-01, LN 59512 WERE REVIEWED AND INDICATE THERE WERE NO NON-CONFORMANCES OR DEVIATIONS DURING THE PRODUCTION THAT MAY HAVE LED TO THE FAILURE.

    Description of Event or Problem · 1

    IN RESPONSE TO FORM 483 ISSUED TO SPECTRANETICS ON (B)(4) 2010, OBSERVATION #2, ALL VIGILANCE REPORTS FILED, WILL ALSO BE FILED WITH THE FDA FOR ALL SAME/LIKE DEVICES SOLD IN THE US. THE MD PRIMED THE THROMCAT WITH NO PROBLEM, INSERTED DEVICE INSIDE OF THE PT WHEN SUDDENLY SHUT DOWN. ON FLUOROSCOPY IT WAS NOTED THE HELIX WAS FRACTURED PRIOR TO THE FIRST RUN. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED BY BALLOON AND STENTING WITH A GOOD RESULT. THERE WERE NO ADVERSE EFFECTS TO THE PT DUE TO THE FRACTURED HELIX. THE MOST PROBABLE ROOT CAUSE IS THAT THE CATHETER WAS KINKED DURING THE PROCEDURE. SINCE THE DEVICE WAS USED IN THE PT IT CAN BE SPECULATED THAT IT PRIMED WELL AND WAS NOT KINKED DURING PACKAGING OR SHIPMENT. ONCE THE HELIX AT THE KINK STARTS TO ROTATE, IT IS CUTTING AWAY AT THE INSIDE OF THE JACKET THROUGH THE LINER AND THE METAL BRAIDING. THIS CAUSES EXCESSIVE RESISTANCE AND THE HELIX IS FORCED TO FRACTURE AT THE DEVICE FRACTURE POINT. WHEN THIS HAPPENS IT TRIGGERS THE INTERNAL DEVICE TO SHUT DOWN AS A SAFETY PRECAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THROMCAT THROMBECTOMY CATHETER SYSTEM THROMCAT MCW SPECTRANETICS CORP. 63000-02 60802

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR