BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETROFLEX 3 INTRODUCER SHEATH SET

    MDR report key: 2991895 · Received March 6, 2013

    Report

    Report Number
    2015691-2013-19454
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 15, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYB
    PMA / PMN Number
    K093877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED SHEATH, DELIVERY SYSTEM AND CRIMPED VALVE WERE RETURNED TO EDWARDS IRVINE. THE DELIVERY SYSTEM WAS RETURNED INSERTED THROUGH THE SHEATH AND STILL HAD THE VALVE CRIMPED ON THE BALLOON. UPON EXAMINATION, SIGNIFICANT DAMAGE WAS FOUND ON THE DISTAL TIP THAT WAS NOT INDICATED IN THE ORIGINAL REPORT. VISUAL INSPECTION OF THE RETURNED SHEATH REVEALED TWO KINKS LOCATED AT THE MIDDLE PORTION OF THE SHAFT AND A TORN RADIOPAQUE TIP THAT HAD NOT BEEN NOTED IN THE REPORT. SCRATCHES WERE ALSO OBSERVED NEAR THE DISTAL TIP. NO OTHER VISUAL ABNORMALITIES WERE NOTED. THE DIMENSIONAL MEASUREMENTS OF THE SHEATH DIAMETERS AND WALL THICKNESS WERE FOUND TO MEET SPECIFICATIONS. THE CONDITION OF THE RETURNED SHEATH DID NOT ALLOW FOR A FUNCTIONAL TESTING TO BE PERFORMED AS PART OF THE DEVICE EVALUATION. DAMAGE ON THE SHEATH WAS CONFIRMED, BUT NO MANUFACTURING NON-CONFORMITIES COULD BE FOUND IN THE RETURNED SAMPLE. THE RETURNED PRODUCT EVALUATION REVEALED THAT THE SHEATH DISTAL TIP WAS TORN. THE ROOT CAUSE FOR THE REPORTED EVENTS CANNOT BE CONFIRMED. HOWEVER, THE AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS (I.E. REPORTED BORDERLINE ACCESS VESSEL DIAMETER FOR A 24F SHEATH, UNEXPECTED VESSEL TORTUOSITY) MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE TIP DAMAGE WAS LIKELY CAUSED BY PATIENT CALCIFICATION, AS EVIDENCED BY THE SCRATCHES ON THE DISTAL END OF THE SHAFT. THE IFU AND TRAINING MANUALS HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME. THIS IS ONE OF TWO REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE (B)(4): MANUFACTURER REPORT NO. 2015691-2013-19251.

    Description of Event or Problem · 1

    PER REPORT, THE RETROFLEX (RF3) SHEATH KINKED WHILE ADVANCING THE RF3 CATHETER. IT WAS NOT POSSIBLE TO MOVE THE CATHETER FORWARD OR BACKWARD. THE PHYSICIAN WAS UNABLE TO ADVANCE THE RF3 DELIVERY SYSTEM AND EXIT THE SHEATH. THE SHEATH/DELIVERY SYSTEM/VALVE WERE REMOVED TOGETHER ALONG WITH THE WIRE FROM THE PATIENT. A NEW SHEATH AND RF3 WERE PREPPED AND INSERTED AND RESISTANCE OCCURRED WHEN PUSHING THE DELIVERY SYSTEM THROUGH THE SHEATH, BUT THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY.ADDITIONAL INFORMATION OBTAINED THROUGH INVESTIGATION: THE ACCESS VESSEL HAD A BORDERLINE MINIMUM LUMINAL DIAMETER (MLD) FOR A 24FR SHEATH; IN ADDITION, THE VESSEL TURNED OUT TO BE MORE TORTUOUS THAN WHAT THE SCREENING IMAGES PREDICTED. NOTHING UNUSUAL WAS NOTICED WHEN PREPPING THE SHEATH OR THE RF3 DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96346 RETROFLEX 3 INTRODUCER SHEATH SET INTRODUCER, CATHETER DYB EDWARDS LIFESCIENCES 9120S26 59320435

    Patients

    Seq Age Sex Outcome Treatment
    1 100 YR