BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBOLECTOMY/THROMBECTOMY CATHETER

    MDR report key: 1994356 · Received January 14, 2011

    Report

    Report Number
    1721279-2008-00038
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    August 20, 2008
    Report Date
    August 22, 2008
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MCW
    PMA / PMN Number
    K060016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. DURING THE USE OF THE THROMCAT CATHETER ON A MALE PT WITH AN ACUTE MI IN THE LCA, THE CATHETER'S HELIX TIP FRACTURED. THE PHYSICIAN REMOVED THE DEVICE FROM THE PT'S BODY AND UTILIZED ANOTHER THROMCAT CATHETER AND COMPLETED THE PROCEDURE. THERE WAS NO PT INJURY AS REPORTED BY THE ATTENDING PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOLECTOMY/THROMBECTOMY CATHETER THROMCAT MCW SPECTRANETICS CORP. 63000-02 70719

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK