BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSNARE SYSTEM

    MDR report key: 5302816 · Received September 14, 2004

    Report

    Report Number
    1036710-2004-00005
    Event Type
    Malfunction
    Date Received
    September 14, 2004
    Manufacturer
    MEDICAL DEVICE TECHNOLOGIES, INC.
    Product Code
    MMX
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE RETURNED UNIT DID NOT CONTAIN THE PLATINUM RING. THE DISTAL PORTION OF THE CATHETER DISPLAYED INDENTS WHERE THE RING WAS ATTACHED, INDICATIVE OF A SUCCESSFUL ATTACHMENT. THE OD AND ID OF THE CATHETER WAS WITHIN ACCEPTABLE SPECIFICATIONS. ACCORDING TO THE DR, THE CATHETER TIP CONTACTED THE STENT DURING RETRIEVAL, OR THE DISTAL TIP OF THE INTRODUCER NEEDLE DURING REMOVAL OF THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSNARE SYSTEM VASCULAR RETRIEVAL MMX MEDICAL DEVICE TECHNOLOGIES, INC. 21990EIQ

    Patients

    Seq Age Sex Outcome Treatment
    1