BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAVASCULAR RETRIEVAL SNARE

    MDR report key: 1587221 · Received January 8, 2010

    Report

    Report Number
    1036710-2010-00001
    Event Type
    Malfunction
    Date Received
    January 8, 2010
    Date of Event
    December 11, 2009
    Report Date
    December 11, 2009
    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. THE INCOMING INSPECTION RECORDS OF THE RAW MATERIAL CATHETER WERE REVIEWED. A FINGER PULL TEST IS REQUIRED AT INCOMING INSPECTION OF THE CATHETER. THE RESULTS OF THE RAW MATERIAL FINGER PULL TEST WERE FOUND ACCEPTABLE. THERE WERE NO DEFECTS OR DEVIATIONS NOTED. THE DEVICE WAS RETURNED AND EVALUATED. THE CATHETER RETURNED IS MISSING THE RADIOPAQUE BAND AS STATED BY THE CUSTOMER; THEREFORE, THE FAILURE WAS CONFIRMED. INDENTATIONS AT THE ORIGINAL RING POSITION WERE VISIBLE, INDICATIVE THAT THE PLATINUM RING WAS ASSEMBLED CORRECTLY. APART FROM THE SEPARATED RING NO ANOMALIES WERE IDENTIFIED IN THE PRODUCT. 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: THEY WERE PERFORMING A FOREIGN BODY RETRIEVAL THROUGH AN 11 FR ANGIO SHEATH USING ENSNARE. THEY ADVANCED THE ENSNARE CATHETER AND THEN THE ENSNARE. THE RADIOPAQUE BAND CAME OFF THE DISTAL END OF THE CATHETER. A 3 HOUR PROCEDURE WAS REQUIRED TO RETRIEVE THE RADIOPAQUE BAND AND 1 RETRIEVAL DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRAVASCULAR RETRIEVAL SNARE ENSNARE SYSTEM MMX ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES 392007030 91341UEK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other