BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOR INTRODUCER SHEATH

    MDR report key: 2022840 · Received February 16, 2011

    Report

    Report Number
    1820334-2011-00085
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 2011
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT OUTCOME WAS NOT PROVIDED BY THE REPORTER. VALVE RUPTURES ARE NOT SPECIFICALLY ADDRESSED IN THE IFU. NO PRODUCT WAS PROVIDED TO ASSIST IN THIS INVESTIGATION. THE FLEXOR CHECK-FLO II INTRODUCER ARE INSPECTED 100% TO CONFIRM FLARE ON PROXIMAL END OF SHEATH IS CAUGHT SECURELY IN PROXIMAL FITTINGS, SHEATH DOES NOT ROTATE IN CAP FITTING, AND VERIFY THAT COILS IN SHEATH CONTINUE INTO CAP. ALSO THE FLEXOR SHEATH INSTRUCTS TO TRIM THE FLARE EVENLY AND CHECK EACH FLARE WITH APPROPRIATE FLARE GAUGE; INSPECT ALL FLARES. THE FLARE MUST NOT PASS THROUGH SMALL GAUGE HOLE FREELY. CHECKING IS REPEATED WITH THE LARGE HOLE IN GAUGE. THE FLARE MUST PASS THROUGH LARGE HOLE FREELY. FURTHERMORE, THE INSTRUCTIONS FOR USE (IFU) INFORMS THE END USER THAT ALL CATHETERS AND INSTRUMENTS USED WITH THIS INTRODUCER SHOULD MOVE FREELY THROUGH THE VALVE AND SHEATH. IT IS DIFFICULT TO DETERMINE WITH ANY CERTAINTY WHY THE PHYSICIAN EXPERIENCED THIS FAILURE MODE FOR THIS PRODUCT. WHILE THIS COMPLAINT IS RELEVANT TO THE SCOPE OF ACTIONS STEPS BEING TAKEN FOR PROXIMAL FITTING SEPARATION FROM THE SHEATHS, THIS WAS ISSUED AT MANAGEMENT DISCRETION PRIOR TO THE RECEIPT OF THIS COMPLAINT. INTERIM ACTION STEPS WERE IMPLEMENTED ON (B)(6) 2010 FOR THE USE OF TORQUE LIMITING DEVICES FOR THE ATTACHMENT OF PROXIMAL FITTINGS ON FLEXOR SHEATHS < 9.0FR. ACCORDING TO MFG RECORDS, THE COMPLAINT DEVICE WAS MANUFACTURED PRIOR TO THE NOTED CHANGE. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED OF THIS COMPLAINT AND WE ARE CONTINUING TO MONITOR COMPLAINTS FOR SIMILAR EVENTS. RELEVANT TO THIS FAILURE MODE OF HUB SEPARATION, THIS DEVICE WAS MANUFACTURED AFTER THE IMPLEMENTATION ON (B)(6) 2008.

    Description of Event or Problem · 1

    THE PHYSICIAN TOOK THE SHEATH FOR A THOMBEKTOMIE WITH THE ROTAREX SYS. DURING THE PROCEDURE, THE SHAFT OF THE SHEATH RUPTURE FROM THE HAEMOSTASIS VALVE. PT OUTCOME AND ADDITIONAL PROCEDURAL DETAILS WERE NOT PROVIDED BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXOR INTRODUCER SHEATH DYB INTRODUCER, CATHETER DYB COOK, INC. NA F2546137

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK