BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETROFLEX3 DELIVERY SYSTEM

    MDR report key: 2954059 · Received February 11, 2013

    Report

    Report Number
    2015691-2013-19244
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    December 6, 2012
    Report Date
    February 6, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETROFLEX DELIVERY SYSTEM WAS RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION. A MORE SIGNIFICANT FAILURE THAN WAS ORIGINALLY REPORTED WAS DETECTED AT THIS TIME. VISUAL AND FUNCTIONAL TESTING WAS PERFORMED. UNDER MAGNIFICATION, ONE OF THE ADHESIVE PORTS APPEARED CONCAVE. DURING FUNCTIONAL TESTING, THE DEVICE FAILED THE PRESSURE DECAY LEAK TEST. IN ADDITION, THE DELIVERY BALLOON COULD NOT BE SIZED WITH THE SIZING RING AS THE DELIVERY SYSTEM WAS LEAKING THROUGH THE GUIDEWIRE FLUSH PORT. THIS WAS FOLLOWED BY A RED DYE TEST. AS THE BALLOON WAS INFLATED THROUGH THE INFLATION PORT, A LEAK WAS VISIBLE THROUGH THE GUIDE-WIRE LUMEN. POST TESTING, VISUAL INSPECTION OF THE Y-CONNECTOR REVEALED INDICATION OF A LEAK PATH AT THE Y-CONNECTOR, BETWEEN THE BALLOON PORT AND GUIDEWIRE PORT, THROUGH THE ADHESIVE, AROUND THE GUIDEWIRE LUMEN. THE COMPLAINT WAS CONFIRMED AS THE DELIVERY SYSTEM WAS UNABLE TO BE DE-AIRED AND A LEAK PATH WAS OBSERVED AT THE Y-CONNECTOR. THE ROOT CAUSE OF THE LEAK IN THE DELIVERY SYSTEM WAS DETERMINED TO BE A LEAK PATH IN THE Y-CONNECTOR TO THE GUIDE-WIRE SHAFT BOND. DURING EVALUATION ONE COULD SEE THE LEAK PATH WHERE THE SALINE AND CONTRAST SOLUTION ENTERED DUE TO THE ABSENCE OF ADHESIVE IN THAT AREA. PER THE MANUFACTURING PROCEDURE, A 100% LEAK TEST IS PERFORMED. IN ADDITION, THE Y-CONNECTOR BONDS ARE 100% INSPECTED FOR VOIDS, BUBBLES, OR VISUAL DEFECTS AND THE PROCEDURE STATE TO REJECT ANY COMPONENTS WHERE THE ADHESIVE IS COVERING LESS THAN 90% OF THE BONDS SURFACE, OR IF THERE IS ANY VISUAL INDICATION OF LEAK PATH, EXCESSIVE ADHESIVE ON THE OUTSIDE OF THE Y-CONNECTOR, EVIDENCE OF ADHESIVE WITHIN THE OUTER SHAFT OR GW LUMENS, PARTICULATE CAPTURE, BURNS, OR OTHER VISUAL DEFECTS. THESE INSPECTIONS MAKE IT UNLIKELY THAT A PRE-EXISTING LEAK PATH WAS PRESENT DURING THE MANUFACTURING PROCESS. IN THIS CASE, IT IS DIFFICULT TO DETERMINE IF THE LEAK PATH CONDITION OF THIS SPECIFIC UNIT WAS MISSED IN MANUFACTURING OR IF IT DEVELOPED AT SOME POINT AFTER COMPLETION OF THE MANUFACTURING PROCESS. RETRAINING OF THE MANUFACTURING OPERATORS WAS PERFORMED TO REJECT FOR LEAK PATHS IN THE Y-CONNECTOR TO GUIDEWIRE LUMEN BOND AND TO HAVE A MINIMUM OF 90% ADHESIVE COVERAGE IN THE BOND AREA. THE INSTRUCTIONS FOR USE AND THE TRAINING MANUAL WERE REVIEWED AND NO IFU AND TRAINING DEFICIENCIES WERE IDENTIFIED.THE IFU STEPS FOR PREPPING THE RF3 DELIVERY SYSTEM CALL FOR THE DEVICE FIRST TO BE DE-AIRED AND THEN TO SIZE THE BALLOON BY INFLATING THE BALLOON INSIDE THE BALLOON GAUGE UNTIL THE BALLOON REACHES THE CORRECT DIAMETER. AFTER THE BALLOON IS PROPERLY SIZED, THE BALLOON IS DEFLATED. THE PREPPING AND BALLOON SIZING STEPS MAKE IT HIGHLY LIKELY THAT A Y-CONNECTOR LEAK PATH WOULD BE DETECTED BEFORE EVER REACHING A PATIENT. NO FURTHER ACTION IS REQUIRED AT THIS TIME. TRENDING FOR THIS ISSUE WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS CLINICAL SPECIALIST, THE RETROFLEX3 DELIVERY SYSTEM LEAKED THROUGH THE WIRE PORT DURING PREPARATION OF THE DEVICE PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58393 RETROFLEX3 DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9120FS23 59250507

    Patients

    Seq Age Sex Outcome Treatment
    1