BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON

    MDR report key: 6740136 · Received July 25, 2017

    Report

    Report Number
    2029214-2017-00918
    Event Type
    Malfunction
    Date Received
    July 25, 2017
    Date of Event
    January 19, 2017
    Report Date
    July 18, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    KRA
    PMA / PMN Number
    K093750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ECHELON-10 MICRO CATHETER WAS RETURNED FOR ANALYSIS AND THE CLINICAL OBSERVATION WAS CONFIRMED AS THE MICRO CATHETER DISTAL TIP WAS FOUND TO BE DAMAGED. HOWEVER, THE CAUSE COULD NOT BE DETERMINED. THE MICRO CATHETER DISTAL TIP IS NOTED TO BE PRE-SHAPED. APPROXIMATELY 2.0MM OF THE DISTAL MARKER BAND AND TIP WERE FOUND MISSING AND WERE NOT RETURNED. THE WHEREABOUTS OF THE MISSING SEGMENT IS CURRENTLY UNKNOWN. THE TUBING MATERIAL AT THE DISTAL BROKEN END EXHIBITED WITH JAGGED EDGES AND STRETCHING WITH THE INNER ELLIPTICAL WIRE EXPOSED. NO OTHER ANOMALIES WERE OBSERVED. THE ECHELON-10 MICRO CATHETER WAS REPORTED TO BE MODIFIED BEYOND ITS REPORTED DAMAGED CONDITION. IN ADDITION, IMAGES OF THE PRIOR TO THE MODIFICATION WERE NOT PROVIDED. IT IS POSSIBLE FOR THE MICRO CATHETER DISTAL TIP TO BECOME DAMAGED IF NOT REMOVED CAREFULLY FROM WITHIN THE PACKAGING. PER THE ECHELON IFU (INSTRUCTIONS FOR USE): DIRECTIONS FOR USE - ¿MODEL NUMBERS 145-5091-150, 145-5092-150, 190-5091-150, AND 190-5092-150 ARE PROVIDED IN A TRAY WITH LID, AND THE CATHETER TIP IS HELD WITHIN THE GROOVE OF A CURVE RETAINER. TO OPEN THE TRAY, LIFT THE LID AT THE CORNER OF THE TRAY WITH THE CATHETER HUB. THE CATHETER AND CURVE RETAINER MAY BE REMOVED FROM THE TRAY TOGETHER. TO FREE THE CATHETER TIP FROM THE CURVE RETAINER, PINCH TWO OPPOSITE CORNERS BACK. THIS OPENS THE GROOVE. LIFT THE CATHETER TIP OUT OF THE GROOVE. INSPECT THE CATHETER PRIOR TO USE TO VERIFY THAT IT IS UNDAMAGED.¿ ADDITIONAL FOLLOW UP WAS CONDUCTED TO VERIFY THE CONDITION OF THE RETURNED DEVICE, AND THE SITE NOTED THAT THE CATHETER WAS FLUSHED AS DIRECTED, BUT IT WAS NOT POSSIBLE SHAPE THE TIP INTO THE EXPECTED SHAPE. THE SITE REPORTED THAT THE TIP MAY HAVE DETACHED AT THIS TIME.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THE HEAD OF THE CATHETER WAS DEFORMED AFTER OPENING THE PACKAGE. THE PHYSICIAN USED THE STYLUS TO TRY TO SHAPE THE TIP, BUT COULD NOT RESTORE IT TO A NORMAL 45 DEGREE SHAPE. THE DEVICE DID NOT ENTER THE PATIENT AND WAS REPLACED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE CATHETER WAS RECEIVED FOR EVALUATION AND UPON EXAMINATION, THE TIP WAS FOUND TO BE DETACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521309 ECHELON CATHETER, CONTINUOUS FLUSH KRA COVIDIEN (IRVINE) 145-5091-150 A313328

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR