FDA.reportPublic FDA data

MAUDE MDR 6248518

MDR report key
6248518
Report number
9614654-2017-00002
Event key
0
Event type
3
Date of event
2016-12-20
Date received
2017-01-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. KAZUHIKO INOUE
Address
2-3-18 NAKANOSHIMA,KITA-KU OSAKA, OSAKA 530-8 JA
Phone
318-318-3181
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LACRIFASTLACRIMAL STENTKANEKA CORPORATIONOKSLF2-R090Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-01-1301. O

Event Narratives#

N

Patient 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 U.S UNDER 510(K) # K120886. THE ACTUAL DEVICE USED WAS RETURNED AND INVESTIGATED: THERE WAS A HOLE, FROM WHERE THE BOUGIE WAS THOUGHT TO PENETRATE OUT, IN THE SIDEWALL OF THE TUBE (COLORED IN CLEAR) WHERE A STAINLESS STEEL RING WAS MOUNTED, AND THE RING WAS DISMOUNTED AND MISSING. THE RING'S WHEREABOUTS WAS NOT CONFIRMED DURING THE PROCEDURE IN THIS EYE CLINIC, AND ACCORDINGLY, THE MISSING STAINLESS STEEL RING MIGHT HAVE BEEN REMAINING IN THE PATIENT BODY. 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 BOUGIE INSERTED FORCIBLY IN THE OCCLUDED LACRIMAL DUCT, 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 BOUGIE WITH THE RING OUT OF THE TUBE.

D

Patient 1

THIS DEVICE (LACRIFAST) WAS EMPLOYED TO TREAT THE EPIPHORA DUE TO LACRIMAL DUCT OBSTRUCTION. THE DOCTOR INSERTED ONE OF THE LACRIMAL DUCT TUBE (COLORED IN CLEAR) INTO THE LACRIMAL DUCT. 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 USED ANOTHER LACRIFAST AND COMPLETED THE OPERATION.