BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARCRIFAST

    MDR report key: 4669231 · Received April 1, 2015

    Report

    Report Number
    9614654-2015-00005
    Event Type
    Malfunction
    Date Received
    April 1, 2015
    Date of Event
    March 3, 2015
    Report Date
    April 1, 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 UNITED STATES UNDER THIS DEVICE NAME, BUT IS IDENTICAL TO THE DEVICE "LACRIFLOW LACRIMAL STENT" DISTRIBUTED IN UNITED STATES UNDER 501(K) #K120886. THE ACTUAL DEVICE USED WAS RETURNED AND INVESTIGATED: THE STAINLESS STEEL RING MOUNTED IN THE TIP OF THE BLUE-COLORED TUBE WAS DISMOUNTED AND MISSING. THE OUTER/INNER DIAMETERS, LENGTH, AND ALL OTHER DIMENSIONS OF BOTH TUBES WERE CONFIRMED WITHIN THE SPECIFICATIONS. THE DEVICE HISTORY RECORD (DHR) OF THE LACRIFAST WITH LOT NO. KP104484 WAS REVIEWED AND NO NONCONFORMITY OR ABNORMALITY WAS FOUND IN ITS MANUFACTURING PROCESSES. THE DEVICE MET ITS MATERIAL, ASSEMBLING AND PRODUCT. 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 ATTEMPTED TO PULL OFF THE SHEATH ALONE FORCIBLY WITH THE TUBE PLACED IN THE LESION, FURTHER EXCESSIVE FORCE WAS LOADED ON THE RING AND IT RESULTED IN THE BOUGIE'S PENETRATING OUT OF THE TUBE WITH THE RING.

    Description of Event or Problem · 1

    THIS DEVICE (LACRIFAST) WAS EMPLOYED TO TREAT EPIPHORA DUE TO LACRIMAL DUCT OCCLUSION. THE DOCTOR INSERTED ONE OF THE LACRIMAL DUCT TUBE (COLORED IN BLUE) BY USING A MODIFIED SHEATH GUIDED INTUBATION (SGI) TECHNIQUE. THE DOCTOR FELT A STRONGER RESISTANCE THAN USUAL DURING THE INSERTION OF THIS TUBE INTO THE SHEATH PRE-INSERTED IN THE OCCLUDED LESION. HE ATTEMPTED TO PULL OUT THE SHEATH ALONE OUT OF THE PT'S LACRIMAL DUCT WITH THE TUBE PLACED IN THE PATIENT'S LACRIMAL DUCT, THE TUBE WAS ALSO REMOVED TOGETHER WITH THE SHEATH. IT WAS FOUND THAT THE BOUGIE PENETRATED OUT OF THE TUBE. A NEW "LACRIFAST" WAS PLACED IN THE LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215741 LARCRIFAST LACRIMAL STENT OKS KANEKA CORP. KP104484

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR