BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAVASCULAR RETRIEVAL SNARE

    MDR report key: 1648351 · Received March 25, 2010

    Report

    Report Number
    1036710-2010-00007
    Event Type
    Malfunction
    Date Received
    March 25, 2010
    Date of Event
    January 15, 2010
    Report Date
    January 19, 2010
    Manufacturer
    ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES
    Product Code
    MMX
    PMA / PMN Number
    K021606
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATES THE RADIOPAQUE BAND CAME OFF THE DISTAL END OF THE CATHETER WHILE THE DOCTOR WAS REPOSITIONING A STINT IN THE URETER. A FINGER PULL TEST IS REQUIRED AT INCOMING INSPECTION OF THE CATHETER TO ENSURE THE BAND IS ASSEMBLED APPROPRIATELY. THERE WERE NO DEFECTS OR DEVIATIONS NOTED. THE SUPPLIER OF THE CATHETER WAS CONTACTED AND THEY VERIFIED THE RAW MATERIAL CATHETER WAS MANUFACTURED WITH NO DEFECTS OR DEVIATIONS NOTED. THE SAMPLE IS UNAVAILABLE FROM THE CUSTOMER FOR INVESTIGATION. THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED WITHOUT REVIEWING THE DEVICE USED. PREVIOUS COMPLAINTS WERE REVIEWED FOR THE SAME DEFECT MODE. IN THOSE CASES THE ROOT CAUSE OF THIS OCCURRENCE EXPERIENCED BY THE CUSTOMER WAS DUE TO EXCESSIVE FORCE OR ABNORMAL INTERACTION DURING THE PROCEDURE. THE DFU FOR THE PRODUCT STATES THAT EXCESSIVE FORCE MAY CAUSE DAMAGE TO THE CATHETER.

    Description of Event or Problem · 1

    HOSPITAL REPORTED: DR. (B)(6) WAS REPOSITIONING A STINT IN THE URETER WHEN THE RADIOPAQUE BAND CAME OFF THE ENSNARE CATHETER IN THE URETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRAVASCULAR RETRIEVAL SNARE ENSNARE SYSTEM MMX ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES 392007030 93421YBN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other