BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LACRIFAST

    MDR report key: 3961118 · Received May 27, 2014

    Report

    Report Number
    9614654-2014-00006
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 22, 2014
    Report Date
    May 20, 2014
    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 CEMENTED DEVICE "LACRIFAST" IS NOT DISTRIBUTED IN US UNDER THIS DEVICE NAME, BUT IS IDENTICAL TO THE DEVICE "LACERFLOW LACRIMAL STENT" DISTRIBUTED IN US UNDER 510 (K) # 5120886. THE ACTUAL DEVICE USED WAS RETURNED AND INVESTIGATED: WE CONFIRMED THAT THE STAINLESS STEEL RING MOUNTED IN THE COLORLESS DUCT TUBE WAS DROPPED OFF. THE RING IN THE BLUE-COLORED DUCT TUBE REMAINED INTACT. THERE WERE A LOT OF WOUNDS IN THE OUTER SURFACE OF THE COLORLESS DUCT TUBE, HOWEVER, SUCH WOUND WAS LESS SEEN ON THE BLUE-COLORED DUCT TUBE. THE OUTER/INNER DIAMETERS, LENGTH, AND ALL OTHER DIMENSION OF BOTH DUCT TUBES WERE CONFIRMED WITHIN THE SPECS. THE COLORLESS DUCT TUBE WAS CUT INTO HALF BY ITS LONGITUDINAL AXIS AND ITS CROSS SECTION WAS OBSERVED, AND CONFIRMED THAT THE RING HAD BEEN PROPERLY MOUNTED IN THE DUCT TUBE. THE DEVICE HISTORY RECORD (DHR) OF THE LACRIFAST WITH LOT NO. KP123164 WAS REVIEWED AND NO NONCONFORMITY OR ABNORMALITY WAS FOUND IN ITS MFG PROCESSES. THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECS. ACCORDING TO THE DOCTOR, NO AFTEREFFECT OF THE EVENT SPECS. AS A POSSIBLE CAUSE OF DROPPING OFF THE RING DURING THE USE, WE SPECULATE AS FOLLOWS: WHEN THE DOCTOR TRIED TO INSERT AND ADVANCE THE DUCT TUBE THROUGH THE SHEATH FORCIBLY, EXCESSIVE MECHANICAL FORCES WERE LOAD IN THE DISTAL TIP OF THE DUCT TUBE WHERE THE RING WAS MOUNTED AND THE RING WAS FINALLY DISMOUNTED TO DROP OFF OUT OF THE DUCT TUBE.

    Description of Event or Problem · 1

    THIS DEVICE (LACRIFAST) WAS EMPLOYED TO TREAT EPIPHORA DUE TO OBSTRUCTIONS IN A COMMON INTERNAL PUNCTUM AND INFERIOR END OF NASOCRIMAL DUCT OF A (B)(6) FEMALE PT. THE DOCTOR INSERTED FIRST THE BLUE-COLORED LACRIMAL DUCT TUBE OF THE DEVICE INTO THE SUPERIOR LACRIMAL CANALICULI. SINCE THE INFERIOR END OF THE NASOLACRIMAL DUCT WAS CONSTRUCTED, THE DOCTOR TRIED TO INSERT THE COLORLESS LACRIMAL DUCT TUBE INTO THE INFERIOR LACRIMAL CANALICULI BY USING A SHEATH GUIDED INTUBATION TECHNIQUE (SGI). WHEN THE DOCTOR TRIED TO PULL OFF THE SHEATH FROM THE LACRIMAL PUNCTUM, THE DOCTOR FELT STRONG RESISTANCE AND THE LACRIMAL DUCT TUBE WAS BENT. THE DOCTOR RETRIEVED THE LACRIMAL DUCT TUBE AND FOUND THAT A STAINLESS STEEL RING MOUNTED IN THE DISTAL TIP OF THE LACRIMAL DUCT TUBE WAS MISSING. THE DOCTOR FOOD THE DROPPED-OFF RING IN THE NASOLACRIMAL DUCT OF THE PT AND TRIED TO TAKE IT OUT BY USING A FORCEPS, HOWEVER, THE FORCEPS USED WAS NOT GOOD ENOUGH TO PICK IT UP AND IT FINALLY DROPPED OFF INTO THE ORAL CAVITY AND THE PT SWALLOWED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311948 LACRIFAST LACRIMAL STENT OKS KANEKA CORP. KP123164

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other