BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LACRIFAST

    MDR report key: 6203722 · Received December 25, 2016

    Report

    Report Number
    9614654-2015-00016
    Event Type
    Malfunction
    Date Received
    December 25, 2016
    Date of Event
    September 26, 2015
    Report Date
    November 17, 2015
    Manufacturer
    KANEKA CORPORATION
    Product Code
    OKS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    - THE CONCERNED DEVICE "LACRIFAST" IS NOT DISTRIBUTED IN US UNDER THIS DEVICE NAME, BUT IS IDENTICAL TO THE DEVICE "LACRIFLOW LACRIMAL STENT" DISTRIBUTED IN US UNDER 510(K) # K120886.- THE ACTUAL DEVICE USED WAS RETURNED AND INVESTIGATED:THE STAINLESS STEEL RINGS MOUNTED IN THE TIP OF BOTH TUBES WERE DISMOUNTED AND MISSING. THE OUTER/INNER DIAMETERS, LENGTH, AND ALL OTHER DIMENSIONS OF BOTH TUBES WERE CONFIRMED WITHIN THE SPECIFICATIONS.- AS A POSSIBLE CAUSE OF THE PENETRATION OF THE BOUGIE AND DROPPING OFF THE RING DURING THE USE, WE SPECULATE AS FOLLOWS: WHEN THE DOCTOR TRIED TO INSERT AND ADVANCE THE TUBE WITH THE INSERTED BOUGIE FORCIBLY IN THE INSUFFICIENTLY OPENED LACRIMAL DUCT BY THE PRE-PROBING PROCEDURE, EXCESSIVE MECHANICAL FORCE WAS LOADED ON THE RING AND THE DISTAL TIP OF THE TUBE WHERE THE RING WAS MOUNTED, AND FURTHER PUSHING THE BOUGIE RESULTED IN PENETRATION OF THE BOUGIE WITH THE RING OUT OF THE TUBE.

    Description of Event or Problem · 1

    THIS DEVICE (LACRIFAST) WAS EMPLOYED TO TREAT THE EPIPHORA DUE TO LACRIMAL DUCT OBSTRUCTION OF A (B)(6) MALE PATIENT. THE DOCTOR OPENED THE LACRIMAL DUCT BY USING A METAL BOUGIE, THEN INSERTED ONE OF A PAIR OF THE LACRIMAL DUCT TUBES INTO THE LACRIMAL DUCT BY DSI (DIRECT SILICONE INTUBATION) TECHNIQUE. WHILE ADVANCING THE TUBE, THE DOCTOR FELT THAT THE BOUGIE PENETRATED OUT OF THE TUBE AND RETRIEVED IT OUT OF THE PATIENT'S LACRIMAL DUCT. HE TRIED TO PLACE THE OTHER ONE OF THE PAIR OF THE LACRIMAL DUCT TUBES, BUT THE SAME PROBLEM OCCURRED. HE USED ANOTHER LACRIFAST AND COMPLETED THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853811 LACRIFAST LACRIMAL STENT OKS KANEKA CORPORATION KP015034

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other