BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOR RAABE GUIDING SHEATH

    MDR report key: 1812983 · Received August 17, 2010

    Report

    Report Number
    1820334-2010-00400
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 19, 2010
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SEPARATES IS NOT SPECIFICALLY ADDRESSED PER THE PROVIDED IFU. THE DEVICE WAS RETURNED IN A USED AND DAMAGED CONDITION. AN EXAMINATION CONFIRMED THE CAP HAD SEPARATED FROM THE SHEATH WITH THE FLARE INTACT, AND EVIDENCE OF APPROX 1MM ELONGATION AT ONE POINT ALONG THE WIDEST EDGE OF THE FLARE. PROPER CONNECTOR CAP SIZE FLARE SIZE AND SHEATH I.D. WERE CONFIRMED. ADDITIONALLY, THE GAP BETWEEN THE CHECK-FLO BODY FLANGE AND CAP TOP WAS MEASURED AND CONFIRMED TO BE CORRECT. PER QUALITY CONTROL SPECIFICATION, THERE IS A 100% INSPECTION, CONFIRMING THE FLARE ON THE PROXIMAL END OF SHEATH IS CAUGHT SECURELY IN PROXIMAL FITTINGS. IT IS ALSO CONFIRMED THAT THE SHEATH DOES NOT ROTATE IN CAP FITTING AND THAT THE COILS CONTINUE INTO CAP. AN IFU IS PROVIDED 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

    ON (B)(6) THE PHYSICIAN USED THE 7F RAABE SHEATH FOR A CONTRALATERAL INTERVENTION. WHEN THE PROCEDURE WAS COMPLETE, HE WENT TO PULL THE SHEATH OUT AND THE HUB COMPLETELY DISLODGED FROM THE SHAFT PORTION OF THE SHEATH; LEAVING THE SHEATH WITHIN THE PT. THE SHEATH WAS ACTUALLY INSERTED IN THE PATIENTS GROIN UP TO THE HUB. FORCEPS WERE USED TO GRASP THE SHEATH AND PULL IT FROM THE PATIENTS GROIN. THERE WERE NO ADVERSE EFFECTS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXOR RAABE GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK, INC. NA 2485301

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention