BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAVASCULAR RETRIEVAL SNARE

    MDR report key: 1632663 · Received January 19, 2010

    Report

    Report Number
    1036710-2010-00002
    Event Type
    Malfunction
    Date Received
    January 19, 2010
    Date of Event
    December 4, 2009
    Report Date
    December 21, 2009
    Manufacturer
    ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES
    Product Code
    MMX
    PMA / PMN Number
    K021606
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATES THE RADIOPAQUE BAND CAME OFF THE DISTAL END OF THE CATHETER. 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 CUSTOMER IS RETAINING THE ACTUAL DEVICE USED IN THE PROCEDURE. THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED WITHOUT REVIEWING THE DEVICE USED. THE DEVICE RETURNED BY THE CUSTOMER IS FROM THE SAME LOT NUMBER. IT WAS REVIEWED AND WAS MANUFACTURED PROPERLY. THE DEFECT REPORTED WAS DUPLICATED ON THIS DEVICE WITH ABNORMAL INTERACTION WITH A CO-AXIAL NEEDLE. 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: ON (B)(6)2009 - THE PATIENT UNDERWENT PROCEDURE TO HAVE IVC FILTER RETRIEVAL. UPON COMPLETION OF THE PROCEDURE, IT WAS NOTED THAT THE SMALL RADIOPAQUE BAND/RING ON THE END OF THE CATHETER HAD COME OFF. UNDER FLUORO IT WAS FOUND TO BE LODGED IN THE RIGHT PULMONARY ARTERY BRANCH. CATHETER TIP SEEMED TO BE TOTALLY INTACT. NOTE: THE SNARE INVOLVED IN THIS INCIDENT IS BEING RETAINED AT (B)(6). THE CUSTOMER RETURNED ONE UNUSED SNARE WITH THE SAME LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRAVASCULAR RETRIEVAL SNARE ENSNARE SYSTEM MMX ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES 392006015 615718XX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other