BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYELOTEC SPINAL ENDOSCOPY ACCESS KIT

    MDR report key: 3478773 · Received June 11, 2013

    Report

    Report Number
    1062474-2013-00001
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Manufacturer
    MYELOTEC, INC.
    Product Code
    HRX
    PMA / PMN Number
    K980734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS EVIDENCED BY THE EVALUATION OF THE RETURNED DEVICE, THE FEP (FLUORINATED ETHYLENE PROPYLENE) BOND WAS MAINTAINED AS DESIGNED BETWEEN THE TWO PARTS FOLLOWING MANUFACTURE. IN ADDITION, A SMALL PORTION OF THE FEP THAT WAS TORN FREE OF THE TUBE REMAINS INSIDE THE MOLDED BODY.

    Description of Event or Problem · 1

    PHYSICIAN EXPERIENCED DIFFICULTY ADVANCING THE TUBE OF THE SHEATH INTO THE TARGETED SITE AND APPEARED TO HAVE BENT THE TUBE. AT THE END OF THE PROCEDURE, UPON THE SHEATH BROKE AT THE CAP / SHEATH ASSEMBLY WHEN THE PHYSICIAN TRIED TO REMOVE THE DEVICE. THE END THAT WAS IN THE TARGETED SITE WAS REMOVED WITH A CLAMP. FOLLOWING THE REMOVAL, SEVERAL X-RAY IMAGES (FLUOROSCOPY) WAS PERFORMED TO VERIFY THAT THERE WERE NO PIECES OF MATERIAL FROM THE INTRODUCER SHEATH THAT HAD BROKEN OFF AND REMAINED INSIDE THE TARGETED SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264786 MYELOTEC SPINAL ENDOSCOPY ACCESS KIT CONVENIENCE ACCESS KIT HRX MYELOTEC, INC. 3653 / MY30512

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention