BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LACRIFAST

    MDR report key: 4528469 · Received February 13, 2015

    Report

    Report Number
    9614654-2015-00002
    Event Type
    Malfunction
    Date Received
    February 13, 2015
    Date of Event
    January 16, 2015
    Report Date
    February 13, 2015
    Manufacturer
    KANEKA CORP.
    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 "LACRIFLOW LACRIMAL STENT" DISTRIBUTED IN US UNDER 510(K) K120886. THE ACTUAL DEVICE USED WAS RETURNED AND INVESTIGATED: THE STAINLESS STEEL RING MOUNTED IN THE TUBE (COLORED IN CLEAR) WAS REMOVED FROM ITS ORIGINAL POSITION, AND THE RING ALONE WAS RETURNED SEPARATELY. THE OUT/INNER DIAMETERS, LENGTH, AND ALL OTHER DIMENSIONS OF BOTH TUBES WERE CONFIRMED WITHIN THE SPECIFICATIONS. NO PARTICULAR DAMAGE WAS FOUND ON THE RING SEPARATELY RETURNED. AS A POSSIBLE CAUSE OF THE PENETRATION OF THE BOUGIE AND DROPPED OFF THE RING DURING THE USE, WE SPECULATE AS FOLLOWS: WHEN THE DOCTOR TRIED TO INSERT AND ADVANCE THE TUBE WITH THE BOUGIE INSERTED FORCIBLY INTO THE SHEATH PLACED IN THE HEAVILY OCCLUDED LACRIMAL CANALICULUS, 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 DISMOUNTING THE RING AND PENETRATION OF THE RING OUT OF THE TUBE.

    Description of Event or Problem · 1

    THIS DEVICE (LACRIFAST) WAS EMPLOYED TO TREAT EPIPHORA DUE TO LACRIMAL CALICULUS OBSTRUCTION OF A (B)(6) FEMALE PATIENT. THE DOCTOR INSERTED ONE OF THE LACRIMAL DUCT TUBE (COLORED IN CLEAR) INTO THE INFERIOR LACRIMAL CANALICULI BY USING A MODIFIED SHEATH GUIDED INTUBATION (SGI) TECHNIQUE. WHEN THE DOCTOR TRIED TO INSERT THE TUBE INTO THE SHEATH PRE-INSERTED IN THE LACRIMAL CANALICULUS, THE DOCTOR FELT STRONG RESISTANCE AND GAVE UP INSERTING IT FURTHER TO PULL OUT THE TUBE OF THE SHEATH. THE DOCTOR FOUND THAT A STAINLESS STEEL RING MOUNTED IN THE DISTAL TIP OF THE TUBE WAS MISSING. THE RING WAS FOUND IN THE REMOVED SHEATH AND FALLEN OUT OF THE SHEATH WITH INSERTING A BOUGIE INTO THE SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108374 LACRIFAST LACRIMAL STENT OKS KANEKA CORP. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other