BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIREXION HI-FLO TRANSEND-18 SYSTEM

    MDR report key: 4230078 · Received November 6, 2014

    Report

    Report Number
    2134265-2014-06593
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 8, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRA
    PMA / PMN Number
    K132947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED WITH THE GUIDEWIRE INSIDE THE CATHETER. THE GUIDEWIRE WAS REMOVED FROM THE CATHETER WITH NO ISSUE. IT WAS OBSERVED THAT THE NITINOL IS BROKEN AT 126.7CM FROM THE PROXIMAL END OF THE DEVICE AND FROM THIS POINT THE LINER IS EXPOSED FOR 99.2CM. THE DISTAL TIP IS INTACT BUT IS DAMAGED. THE HUB IS DETACHED FROM THE DEVICE WHERE THERE IS A CLEAN BREAK IN THE NITINOL SHAFT. A FLUSH CANNOT BE PERFORMED ON THE DEVICE AS IT CONTAINS NO HUB. THE OUTER DIAMETER (OD) WAS MEASURED AT THE DISTAL TIP - 0.035INCHES. THE PROXIMAL END OD WAS MEASURED (NITINOL AND LINER) 0.038INCH. A 0.021INCH PIN GAUGE WAS USED TO MEASURE ID OF DEVICE. A 0.021INCH PIN GAUGE INSERTED INTO THE PROXIMAL END SUCCESSFULLY. A 0.021INCH PIN GAUGE INSERTED INTO THE DISTAL TIP SUCCESSFULLY BUT WITH SOME RESISTANCE. SOME BLOOD WAS NOTED INSIDE THE LINER AND CAN BE SEEN THROUGH THE LINER. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CATHETER ENTRAPMENT ON THE WIRE AND SHAFT SEPARATION OCCURED. DURING HAND INJECTION OF A UTERINE FIBROID EMBOLIZATION PROCEDURE, THE HUB AND INNER CORE OF THE DIREXION HI-FLO TRANSCEND-18 SYSTEM SEPARATED. THE WIRE WAS STUCK INSIDE THE MICROCATHETER. ACCESS WAS LOST. THE PHYSICIAN DOES NOT BELIEVE ANY PART OF THE CATHETER WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO COMPLICATIONS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CATHETER ENTRAPMENT ON THE WIRE AND SHAFT SEPARATION OCCURED. DURING HAND INJECTION OF A UTERINE FIBROID EMBOLIZATION PROCEDURE, THE HUB AND INNER CORE OF THE DIREXION HI-FLO TRANSEND-18 SYSTEM SEPARATED. THE WIRE WAS STUCK INSIDE THE MICROCATHETER. ACCESS WAS LOST. THE PHYSICIAN DOES NOT BELIEVE ANY PART OF THE CATHETER WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO COMPLICATIONS REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714157 DIREXION HI-FLO TRANSEND-18 SYSTEM CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC - CORK M001195940 0016637210

    Patients

    Seq Age Sex Outcome Treatment
    1