BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON

    MDR report key: 6700997 · Received July 11, 2017

    Report

    Report Number
    2029214-2017-00877
    Event Type
    Malfunction
    Date Received
    July 11, 2017
    Date of Event
    June 14, 2017
    Report Date
    September 25, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    KRA
    PMA / PMN Number
    K093750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS, BUT HAS YET NOT BEEN RECEIVED. UPON COMPLETION OF THE DEVICE ANALYSIS A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE MICROCATHETER WAS RETURNED FOR ANALYSIS. AN IMPLANT COIL WAS FOUND PARTIALLY WITHIN THE HUB AND EXTENDING OUT FROM THE DISTAL END OF THE PROXIMAL MICROCATHETER SEGMENT. THE CATHETER WAS FOUND TO BE SEPARATED INTO 3 SECTIONS. THE TIP OF THE RETURNED CATHETER WAS FOUND TO BE STRAIGHT WHICH CONTRADICTS WHAT THE CUSTOMER REPORTED. THE MODEL AND LOT NUMBER (MODEL: 190-5092-150 / A421795) THAT THE CUSTOMER REPORTED BELONGS TO A ECHELON WITH A 90 DEGREE TIP. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, THE CUSTOMER WILL NOT PROVIDE FURTHER INFORMATION. BASED ON THE MICROCATHETER ANALYSIS, THE REPORT CATHETER SEPARATION/BREAK WAS CONFIRMED. THE MICROCATHETER WAS FOUND TO BE SEPARATED IN TO THREE SEGMENTS. THE BROKEN ENDS OF THE MICROCATHETER EXHIBITED JAGGED EDGES, STRETCHING AND NECKING WHICH INDICATE THAT THE MICROCATHETER SEPARATED WHEN EXCEEDING THE TENSILE STRENGTH OF THE TUBING MATERIAL. IT APPEARS THAT EXCESSIVE FORCE WAS REQUIRED TO REMOVE THE MICROCATHETER FROM THE PATIENT. ALL DEVICES ARE 100% INSPECTED FOR DAMAGES AND IRREGULARITIES DURING MANUFACTURE. PER THE ECHELON MICROCATHETER INSTRUCTIONS FOR USE (IFU): WARNING: NEVER ADVANCE OR WITHDRAW AN INTRALUMINAL DEVICE AGAINST RESISTANCE UNTIL THE CAUSE OF THE RESISTANCE IS DETERMINED BY FLUO ROSCOPY. EXCESSIVE FORCE AGAINST RESISTANCE MAY RESULT IN DAMAGE TO THE DEVICE OR VESSEL PERFORATION OR OTHER PATIENT INJURIES. PRECAUTION: THE MICRO CATHETER HAS A LUBRICIOUS HYDROPHILIC COATING ON THE OUTSIDE OF THE CATHETER. IT MUST BE KEPT HYDRATED TO BE LUBRICIOUS. THIS CAN BE ACCOMPLISHED BY ATTACHING THE Y-CONNECTOR TO A CONTINUOUS SALINE DRIP. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED REPORT THAT DURING A DISTAL RIGHT MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM COILING PROCEDURE, THE CUSTOMER REPORTED TO HAVE LOST CONTROL DURING DEPLOYMENT OF THE 4MM COIL. IT WAS SOON REALIZED THAT THE MICROCATHETER HAD BROKEN AND SEPARATED WHEN THE RHV WAS LOOSENED. THE CATHETER "SNAPPED" 1/3 OF THE WAY FROM THE TIP. THE DEVICE WAS SUCCESSFULLY REMOVED AS THE 4MM COIL WAS THROUGH THE CATHETER. NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481511 ECHELON CATHETER, CONTINUOUS FLUSH KRA COVIDIEN (IRVINE) 190-5092-150 A421795

    Patients

    Seq Age Sex Outcome Treatment
    1 Other