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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KANEKA CORP. LACRIFAST LACRIMAL STENT

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KANEKA CORP. LACRIFAST LACRIMAL STENT Back to Search Results
Catalog Number LF-R090
Device Problems Use of Device Problem (1670); Material Deformation (2976); Device Handling Problem (3265)
Patient Problems No Consequences Or Impact To Patient (2199); Excessive Tear Production (2235); Device Embedded In Tissue or Plaque (3165)
Event Date 01/07/2015
Event Type  Malfunction  
Event Description

This device (lacrifast) was employed to treat epiphora due to lacrimal duct occlusion. The dr inserted one of the lacrimal duct tube (colored in blue) into the heavily occluded lacrimal duct with the bougie provided with this device inserting in the tube. Since the dr felt a stronger resistance than usual during the insertion of this tube, he gave up proceeding further and pulled it out of the pt's lacrimal duct. It was found that the bougie penetrated out of the tube. A new "lacrifast" was placed in the lesion.

 
Manufacturer Narrative

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 ring mounted in the tip of the tube inner diameters, length, and all other dimensions of both tubes were confirmed within the spec. The ring removed out of the ring was not returned (lost somewhere in the clinic). The device history record (dhr) of the lacrifast with lot no. Kp094404 was reviewed with no nonconformity or abnormality was found in its mfg processes. The device met its material, assembling and prod spec. As a possible cause of the penetration of the bougie and dropping off the ring during the use, we speculate as follows: when the dr tried to insert and advance the tube with the bougie inserted forcibly in the heavily occluded lesion, excessive mechanical force was loaded on the ring and the distal tip of the tube were the ring was mounted, and further pushing the bougie resulted in dismounting the ring and penetration of the ring out of the tube.

 
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Brand NameLACRIFAST
Type of DeviceLACRIMAL STENT
Manufacturer (Section D)
KANEKA CORP.
osaka
JA
Manufacturer (Section G)
KANEKA CORP.
Manufacturer Contact
masaharu inoue
546 fifth ave
21st floor
new york, NY 10036
8005263522
MDR Report Key4528468
MDR Text Key5361086
Report Number9614654-2015-00001
Device Sequence Number1
Product Code OKS
Combination Product (Y/N)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 02/13/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/13/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberLF-R090
Device LOT NumberKP094404
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer01/20/2015
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/15/2015
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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