BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAITSHOT AORTIC CANNULA

    MDR report key: 2955235 · Received February 11, 2013

    Report

    Report Number
    3008500478-2013-00383
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    K974736
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS CURRENTLY UNDER INVESTIGATION INTO ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE CANNULA WAS VISUALLY INSPECTED AND THE LEAKING WAS CONFIRMED. A LEAK WAS OBSERVED AT THE ESTANE BOND OF THE CANNULA. OTHER LEAKS WERE OBSERVED AT THREE LOCATIONS FROM THE DISTAL TIP OF THE CANNULA. THE ROOT CAUSE OF THE LEAKS HAS BEEN ATTRIBUTED TO THE MANUFACTURING PROCESS OF OVERCOAT PLACEMENT; IN THIS CASE, IT HAS BEEN CONFIRMED THAT THE MOST LIKELY ROOT CAUSE IS THE NEEDLE PUNCTURING THE CANNULAE WALL DURING THIS PROCESS. A CORRECTIVE ACTION HAS BEEN INITIATED FOR THIS EVENT. MANUFACTURING RECORDS HAVE BEEN REVIEWED. 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, AFTER CONNECTING THE AORTICCANNULA TO THE HEART-LUNG MACHINE, A LEAK WAS OBSERVED THROUGH THE CANNULA WALL AT TWO LOCATIONS. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58482 STRAITSHOT AORTIC CANNULA CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES SS23S 59320574

    Patients

    Seq Age Sex Outcome Treatment
    1