BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

    MDR report key: 3173209 · Received May 31, 2013

    Report

    Report Number
    1820334-2013-00236
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 15, 2013
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT WAS RETURNED, ALTHOUGH PHOTO IMAGE WAS PROVIDED TO ASSIST IN THE INVESTIGATION. FLEXOR SHEATHS MEET THE ISO TENSILE REQUIREMENTS THROUGH DESIGN VERIFICATION TESTING. FURTHERMORE, QUALITY CONTROL PERSONNEL INSPECTS TO INSURE THAT THERE IS NO COIL SEPARATION OR BREAKAGE, AND THAT THE MATERIAL IS FREE FROM SURFACE DEFECTS, BUMPS, BULGES AND PROTRUDING COILS. THE BOND MELT IS ALSO INSURED TO BE GOOD. IT WAS REPORTED THAT THE TIP SEPARATED AT THE BOND SITE; HOWEVER, WITHOUT BENEFIT OF INSPECTING THE COMPLAINT DEVICE, IT IS DIFFICULT TO DETERMINE WITH ANY CERTAINTY WHY THIS FAILURE MODE OCCURRED. APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED AND WE ARE CONTINUING TO MONITOR COMPLAINTS FOR SIMILAR EVENTS. RISK ANALYSIS WAS UPDATED BY QUALITY ENGINEERING AND CONCLUDED THAT NO RISK REDUCTION ACTIVITIES ARE REQUIRED. WITH THE ADDITION OF THIS COMPLAINT, THE RISK TO PATIENT REMAINS ACCEPTABLE.

    Description of Event or Problem · 1

    A PATIENT WITH STENOSIS IN THE CAROTID ARTERY UNDERWENT CAROTID ARTERY STENTING (CAS) ON (B)(6) 2013. THE DEVICE WAS USED AS GUIDING SHEATH FOR CAS. AN APPARENT TORTUOSITY EXTENDED FROM RIGHT SUBCLAVIAN ARTERY TO RIGHT COMMON CAROTID ARTERY. ALTHOUGH THE APPARENT TORTUOSITY WAS OBSERVED, THE SHEATH WAS ADVANCED FROM RIGHT BRACHIAL ARTERY TO THE LESION (RIGHT COMMON CAROTID ARTERY) OVER AN INNER CATHETER. WHEN THE PHYSICIAN RETRIEVED THE INNER CATHETER, THE SHAPE OF THE ARTERY BECAME BACK TO THE SHAPE BEFORE DEVICES HAD BEEN INSERTED AND THUS, THE SHEATH GOT BENT. SINCE THE SHEATH SEEMED TO BE KINKED, HE GOT IT OUT OF THE PATIENT'S BODY AND CHECKED. IT WAS CONFIRMED THAT THE CONNECTION PART OF SOFT TIP AND SHAFT (WHERE THE COLOR OF THE MATERIAL CHANGES) WAS KINKED AND PARTIALLY TORN. NO SEPARATION OR REMAINING. ANOTHER MANUFACTURER'S GUIDING SHEATH WAS USED INSTEAD WITHOUT PROBLEM AND THE PROCEDURE WAS COMPLETED. NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241492 FLEXOR SHUTTLE TIBIAL GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK, INC. NA F3672080

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK