BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKDRAW VENOUS CANNULA

    MDR report key: 3053176 · Received April 11, 2013

    Report

    Report Number
    3008500478-2013-00416
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 20, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    K962835
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORT OF THE TIP OF THE QUICKDRAW VENOUS CANNULA, QD25 DETACHED WAS CONFIRMED. THE CANNULA WAS VISUALLY INSPECTED AND FOUND A PART OF CANNULA APPROX. 5 INCHED LONG WAS BROKEN OFF AT THE FIFTH SEGMENT OF THE CANNULA. EDWARDS IS UNABLE TO DETERMINE WHAT CAUSED THE DEVICE IN QUESTION TO BREAK. NO CHARACTERISTICS FOUND ON THE RETURNED DEVICE IMPLICATE A MANUFACTURING CAUSED FAILURE. THE FAILURE MAY BE DUE TO EXCESS TENSILE FORCES BEING PLACED ON THE PRODUCT DURING USE. THESE COMPLAINTS WERE TRENDED TO LOOK FOR SIMILARITIES AND IT WAS DETERMINED THAT THE PERCUTANEOUS METHOD MAY HAVE CONTRIBUTED TO THE SEPARATION OF THE DEVICE. AS THERE HAVE BEEN NO REPORTS OF CANNULA SEPARATION DURING PROCEDURES WHERE THE DIRECT CUT DOWN METHOD WAS USED, THIS SURGICAL TECHNIQUE MUST BE CONSIDERED. AS A RESULTING CORRECTIVE ACTION, EDWARDS HAS RECALLED PRODUCT IN DISTRIBUTION AND IS UPDATING THE IFU TO ADD APPROPRIATE PRECAUTIONS AND WARNINGS. TRENDS WILL CONTINUE TO BE MONITORED ON A MONTHLY BASIS AND IF FURTHER ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY UNDER EVALUATION INTO ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "WHEN THE SURGEON REMOVED THE QUICKDRAW VENOUS CANNULA (25 FR) FROM THE RIGHT FEMORAL VEIN, HE NOTICED THAT THE TIP OF THE CANNULA IS JAGGED. THIS WAS COMMUNICATED TO THE PERFUSIONIST WHO IN TURN TOOK OUT A NEW QUICKDRAW VENOUS CANNULA FOR COMPARISON. ON CLOSE EXAMINATION, IT WAS REALISED THAT THE DECANNULATED QUICKDRAW CANNULA WAS SHORTER THAN THE PRESCRIBED LENGTH OF 65 CM. THE SURGEON COULD FEEL PART OF THE CANNULA IN THE RIGHT GROIN AND UPON EXCISION; HE MANAGED TO PULL OUT THE REMAINING ~13 CM OF THE CANNULA." THE CANNULA INSERTION WAS PERFORMED PERCUTANEOUS. THE CANNULA WAS IN PLACE FOR 4 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155238 QUICKDRAW VENOUS CANNULA CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES QD25 59296463

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR