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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-R105
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 01/16/2015
Event Type  Malfunction  
Event Description

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.

 
Manufacturer Narrative

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.

 
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Brand NameLACRIFAST
Type of DeviceLACRIMAL STENT
Manufacturer (Section D)
KANEKA CORP.
osaka
JA
Manufacturer Contact
masaharu inoue
546 fifth ave.
21st floor
new york, NY 10036
8005263522
MDR Report Key4528469
MDR Text Key18545538
Report Number9614654-2015-00002
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 Other,Foreign,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 02/13/2015
1 Device Was Involved in the Event
1 Patient Was 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-R105
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer01/20/2015
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/16/2015
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

Patient TREATMENT DATA
Date Received: 02/13/2015 Patient Sequence Number: 1
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