BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGELLAN

    MDR report key: 4620339 · Received March 18, 2015

    Report

    Report Number
    3006026430-2015-00002
    Event Type
    Malfunction
    Date Received
    March 18, 2015
    Date of Event
    February 11, 2015
    Report Date
    March 18, 2015
    Manufacturer
    HANSEN MEDICAL, INC.
    Product Code
    DXX
    PMA / PMN Number
    K141614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON LOG FILE INVESTIGATION, THE PHYSICIAN'S TEAM VARIED FROM THE IFU INSTRUCTIONS: THEY SIMULTANEOUSLY PRESSED SYSTEM BUTTONS WHILE REMOVING, THEN INSTALLING THE GUIDE WIRE SUPPORT. IT IS NOT STANDARD PRACTICE TO SIMULTANEOUSLY INSTALL AND REMOVE CATHETERS/WIRE SUPPORTS WHILE PRESSING THE SYSTEM BUTTONS. BASED ON THE INFORMATION FROM THE REPORTING SITE THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS EVENT. THE PHYSICIAN SUCCESSFULLY COMPLETED THE CASE WITH THE SAME MAGELLAN ROBOTIC SYSTEM AND CATHETER.

    Description of Event or Problem · 1

    REPORTED THAT, WITHOUT A USER COMMAND, THE SYSTEM RETRACTED THE CATHETER OUT OF THE PATIENT, REMOVING PATIENT PATCH AND INTRODUCER SHEATH FROM INSERTION SITE. PHYSICIAN REINSERTED SAME CATHETER AND SUCCESSFULLY COMPLETED CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183465 MAGELLAN MAGELLAN ROBOTIC SYSTEM DXX HANSEN MEDICAL, INC. 21550

    Patients

    Seq Age Sex Outcome Treatment
    1