BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETROFLEX 3 DELIVERY SYSTEM

    MDR report key: 2974312 · Received February 22, 2013

    Report

    Report Number
    2015691-2013-19353
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 14, 2013
    Report Date
    February 20, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO EDWARDS FOR EVALUATION. VISUAL, DIMENSIONAL AND FUNCTIONAL ANALYSES WERE CONDUCTED ON THE RETURNED DEVICE. UPON VISUAL INSPECTION NO GROSS VISUAL ABNORMALITIES WERE OBSERVED. HOWEVER, FUNCTIONAL TESTING REVEALED A GROSS LEAK UNDER THE STRAIN RELIEF. THE LEAK WOULD NOT ALLOW THE DEVICE TO BE DE-AIRED AND IT WAS NOT POSSIBLE TO SIZE THE BALLOON. THE STRAIN RELIEF WAS THEN REMOVED FOR INVESTIGATION. A TEAR WAS OBSERVED ON THE OUTER SHAFT UNDER THE STRAIN RELIEF. DIMENSIONAL INSPECTION OF THE INNER DIAMETER (ID) AND OUTER DIAMETER (OD) OF THE OUTER SHAFT DISTAL OF THE BREAK MET SPECIFICATIONS. A DEVICE HISTORY RECORD (DHR) REVIEW, REVEALED THE AFFECTED WORK ORDERS, SPECIFICALLY THE RF3 PACKAGING ASSEMBLY, RF3 ASSEMBLY AND BALLOON CATHETER OUTER SHAFT LOTS DID NOT REVEAL ANY ISSUES THAT COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. A MANUFACTURING DEFECT WAS CONFIRMED ON THE RETURNED DEVICE. ATTEMPTS TO RECREATE THE ISSUE SHOWED THAT ONLY WHEN THERE WAS EITHER A TEAR OR PUNCTURE IN THE TUBING, A TORSIONAL OR TORQUING ACTION ON THE CATHETER CAN CAUSE THE TEAR TO PROPAGATE AND FORM A SIMILAR TEARING PATTERN FOUND IN THE RETURNED COMPLAINT DEVICE. AT THIS TIME, IT IS DIFFICULT TO CONCLUSIVELY DETERMINE AT WHAT POINT IN TIME THE DAMAGE OCCURRED. A DEFINITIVE ROOT CAUSE HAS NOT YET BEEN DETERMINED; THEREFORE A CAPA HAS BEEN INITIATED TO FULLY INVESTIGATE A ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    THE RF3 DELIVERY SYSTEM WAS RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION. THE COMPLAINT WAS CONFIRMED. PRELIMINARY INVESTIGATION REVEALED A LEAK COMING FROM UNDER THE STRAIN RELIEF. THE ENGINEER ALSO NOTED THAT THE STRAIN RELIEF WAS REMOVED AND THE BALLOON SHAFT WAS SEPARATED JUST DISTAL OF THE Y-CONNECTOR. FOLLOW UP EXAMINATION PENDING.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS CLINICAL SPECIALIST, WHILE PREPPING THE RF3 DELIVERY SYSTEM, A LEAK IN THE BALLOON PORT WOULD NOT ALLOW THE BALLOON TO FULLY INFLATE OR PULL NEGATIVE TENSION TO REMOVE AIR BUBBLES. A NEW DEVICE WAS OPENED AND THE CASE WAS ABLE TO BE COMPLETED WITHOUT FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78699 RETROFLEX 3 DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9120FS26 59297189

    Patients

    Seq Age Sex Outcome Treatment
    1