BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAVASCULAR RETRIEVAL SNARE

    MDR report key: 1638508 · Received March 22, 2010

    Report

    Report Number
    1036710-2010-00011
    Event Type
    Malfunction
    Date Received
    March 22, 2010
    Date of Event
    February 26, 2010
    Report Date
    February 26, 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 DISTAL END OF THE DEVICE BECAME DETACHED. 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 MFG WITH NO DEFECTS OR DEVIATIONS NOTED. THE DEVICE IS UNAVAILABLE FROM THE CUSTOMER FOR FURTHER REVIEW. IT IS LIKELY THE 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

    WHILE ATTEMPTING TO REMOVE AN IVC FILTER WITH AN ENSNARE, THE RADIOPAQUE MARKER ON THE CATHETER DISLODGED AND WAS TRAPPED BY THE FILTER. ANOTHER DEVICE WAS THEN USED TO REMOVE BOTH THE FILTER AND THE RADIOPAQUE MARKER. THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRAVASCULAR RETRIEVAL SNARE ENSNARE SYSTEM MMX ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES 392007030 90781TB1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R