BEUDAMED
    FDA Adverse Event Summary report: N

    QUICKDRAW VENOUS CANNULAE

    MDR report key: 2791966 · Received October 16, 2012

    Report

    Report Number
    3008500478-2012-00312
    Date Received
    October 16, 2012
    Date of Event
    September 28, 2012
    Report Date
    March 14, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    K962835
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED FOR EVALUATION. DISCARDED BY THE HOSPITAL. THE PRODUCT WAS NOT RETURNED AN THE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS DEVICE. THEREFORE, A CAPA WAS NOT INITIATED FOR THIS EVENT. THIS INFORMATION WILL BE INCLUDED IN TRENDING AND FUTURE CAPA DETERMINATION.

    Additional Manufacturer Narrative · 1

    EVALUATION: THE CUSTOMER REPORT OF THE TIP OF THE QUICKDRAW CANNULAE DETACHED WAS CONFIRMED. THE CANNULA WAS VISUALLY INSPECTED AND FOUND A PART OF CANNULA APPROX 3 INCHES LONG WAS BROKEN OFF AT THE FIFTH SEGMENT OF THE CANNULA. AS STATED IN THE COMPLAINT REPORT, FOLLOWING THE SEPARATION OF A QUICKDRAW IN THE PATIENT THE PHYSICIAN INTENTIONALLY PULLED ON ONE OF THE UNITS THAT WERE RETURNED AND IT BROKE. THE ROOT CAUSE OF THE DEVICE THAT BROKE INSIDE THE PATIENT CANNOT BE DETERMINED SINCE IT WAS NOT RETURNED. A PRODUCT RISK ASSESSMENT HAS BEEN ISSUED FOR THIS EVENT. THE INFORMATION GATHERED THROUGH THIS REPORTED EVENT AND EVALUATION WILL BE INCLUDED IN TREND DATA FOR FUTURE CAPA DETERMINATIONS. 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

    CORRECTION TO INITIAL ROOT CAUSE DETERMINATION: THE ROOT CAUSE OF THE INCOMPLETE THERMAL BONDS OF THE RETURNED DEVICE IS MOST LIKELY DUE AN OVEN PROCESS TEMPERATURE BEING TOO LOW TO ADEQUATELY FUSE THE THERMAL BONDS OF THE CANNULA. THE ROOT CAUSE OF THE OVERCOAT BREAKING IN ADDITION TO THE INCOMPLETE TECOTHANE BONDS CANNOT BE DETERMINED. ADDITIONAL INFORMATION: BASED ON THE ADDITIONAL INVESTIGATION PERFORMED VIA SURGEON INTERVIEWS ((B)(6) 2013) THE ORIGINAL ANALYSIS IS NOT CONSIDERED TO BE CORRECT. THE ANALYSIS NOW SHOWS THAT THE INCREASED FORCES EXTENDED ON THE CANNULA DURING ITS PERCUTANEOUS INSERTION AND REMOVAL WERE THE MAJOR CAUSE OF THE EVENTS. THROUGH THE ADDITIONAL INVESTIGATION IT WAS FOUND THAT THE PROCESS MET THE CANNULA STRENGTH REQUIREMENT OVER TIME. A TECHNICAL SUMMARY HAS ANALYZED THE VISUAL REQUIREMENT TO TENSILE STRENGTH OF THE CANNULA BODY. THIS INFORMATION ALONG WITH INTERVIEWS FROM SURGEON INTERVIEWS HAS MODIFIED THE ROOT CAUSE CONCLUSIONS FOR THIS COMPLAINT. A PRODUCT RISK ASSESSMENT WAS INITIATED FOR THE COMPLAINT INVESTIGATION. THE INFORMATION GATHERED THROUGH THIS REPORTED EVENT AND EVALUATION WILL BE INCLUDED IN TREND DATA FOR FUTURE CAPA DETERMINATIONS. TRENDS WILL CONTINUE TO BE MONITORED ON A MONTHLY BASIS AND IF FURTHER ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    AS REPORTED ON THE PHONE, THE CANNULA IS BROKEN (CRACKED) ON THE QUICKDRAW VENOUS CANULAE. NO PATIENT INJURY WAS NOTED, THE DEVICE TORE AT THE END OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICKDRAW VENOUS CANNULAE CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES QD25 59287728

    Patients

    Seq Age Sex Outcome Treatment
    1