BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOR RAABE GUIDING SHEATH

    MDR report key: 1813084 · Received August 18, 2010

    Report

    Report Number
    1820334-2010-00409
    Event Type
    Malfunction
    Date Received
    August 18, 2010
    Report Date
    July 27, 2010
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO INFORMATION WAS PROVIDED REGARDING PATIENT OUTCOME/CONDITION. SEPARATES IS NOT SPECIFICALLY ADDRESSED PER THE IFU. THE DEVICE WAS RETURNED IN A USED AND DAMAGED CONDITION. AN EXAMINATION REVEALED THAT THE CAP HAD SEPARATED FROM THE SHEATH WITH THE FLARE INTACT, BUT NO EVIDENCE OF ELONGATION. PROPER CONNECTOR CAP SIZE AND SHEATH I.D (0.087) WERE CONFIRMED. ADDITIONALLY, THE GAP BETWEEN THE CHECK-FLO BODY FLANGE AND CAP TOP WAS MEASURED AT APPROXIMATELY 0.025". PER QUALITY CONTROL SPECIFICATION, THE INTEGRITY OF THIS DEVICE IS 100% INSPECTED, CONFIRMING THE FLARE ON PROXIMAL END OF SHEATH IS CAUGHT SECURELY IN PROXIMAL FITTINGS AND THAT THE SHEATH DOES NOT ROTATE IN CAP FITTING. IN ADDITION, IT IS VERIFIED THAT THE COILS IN SHEATH CONTINUE INTO CAP. THE FLARES ARE ALSO CHECKED. AN IFU IS PROVIDED WITH THIS DEVICE THAT 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. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED OF THIS COMPLAINT AND WE ARE CONTINUING TO MONITOR FOR SIMILAR OCCURRENCES.

    Description of Event or Problem · 1

    WHILE REMOVING THE SHEATH OVER A WIRE AND DILATOR, THE SHEATH DISCONNECTED FROM THE HUB AND BECAME UNUSABLE. SHEATH EXCHANGED AND CASE COMPLETED. NO INFORMATION WAS PROVIDED REGARDING OUTCOME/CONDITION OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXOR RAABE GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK, INC. NA 2526050

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK