BEUDAMED
    FDA Adverse Event Summary report: N

    FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

    MDR report key: 4203654 · Received July 22, 2014

    Report

    Report Number
    1820334-2014-00344
    Date Received
    July 22, 2014
    Date of Event
    June 28, 2014
    Report Date
    June 29, 2014
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE FLEXOR SHUTTLE TIBIAL GUIDE SHEATH FROM THE COMPLAINT LOT NUMBER WAS RETURNED IN A USED AND DAMAGED CONDITION: THE SHEATH HAD PULLED FROM THE CAP WITH THE FLARE INTACT; HOWEVER, THE FLARE WAS DISTORTED AND THE SHEATH HAD ELONGATED JUST BELOW THE BASE OF THE FLARE. THE PROVIDED DILATOR WAS ALSO RETURNED IN A USED CONDITION, BUT OTHERWISE UNREMARKABLE. THIS DEVICE IS INSPECTED, CONFIRMING THE CORRECT PROXIMAL FITTINGS AND THAT FLARE IS CAUGHT SECURELY IN CAP ASSEMBLY. IT IS ALSO VERIFIED THAT THE SHEATH DOES NOT ROTATE AND THAT THE COIL IN SHEATH CONTINUES INTO CAP. DESIGN VERIFICATION TESTING CONFIRMS THE DEVICE MEETS THE TENSILE STRENGTH REQUIREMENTS OF ISO 11070. BASED ON OUR EXAMINATION OF THE RETURNED PRODUCT AND THE INVESTIGATION RESULTS, THE ROOT CAUSE WAS DETERMINED TO BE PRODUCT USE OF HANDLING RELATED AS THE DEVICE WAS SUBJECTED TO FORCES BEYOND ITS DESIGN STRENGTH. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. QUALITY ENGINEERING EVALUATED THE RISK TO PATIENT AND PER THE QERA, IT WAS CONCLUDED THAT, WITH THE ADDITION OF THIS COMPLAINT, NO RISK MITIGATION ACTIONS ARE NEEDED.

    Description of Event or Problem · 1

    DURING A SFA PROCEDURE ON A (B)(6) YEAR-OLD MALE PATIENT, THE SHEATH WAS INSIDE THE PATIENT'S BODY ALMOST (B)(6), WHEN THE CONNECTOR (AT THE PROXIMAL END) BECAME DISCONNECTED FROM THE SHAFT AND BLOOD BEGAN FLOWING OUT. THE BLOOD LOSS WAS MORE THAN NORMAL AND WITH LOTS OF DIFFICULTY THE PHYSICIAN EXCHANGED THE SHEATH. ADDITIONAL INFORMATION ON (B)(6) STATED THAT THERE WAS NO ADVERSE EVENT. DUE TO THE BLOOD LOSS THE PHYSICIAN DID NOT PROCEED WITH THE PROCEDURE AND THE PATIENT WAS SCHEDULED FOR A PROCEDURE DURING NEXT WEEK. ADDITIONAL INFORMATION PROVIDED (B)(6) 2014: THE ARTERY OF THE PATIENT WAS OCCLUDED AND DUE TO THE CONDITION OF THE PATIENT, THE PHYSICIAN DECIDED TO WAIT A WEEK BEFORE CONTINUING WITH THE PROCEDURE. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER KSAW SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428880 FLEXOR SHUTTLE TIBIAL GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK, INC. NA 4598621

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR