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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KANEKA CORP. LARCRIFAST LACRIMAL STENT

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KANEKA CORP. LARCRIFAST 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 03/03/2015
Event Type  Malfunction  
Event Description

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.

 
Manufacturer Narrative

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.

 
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Brand NameLARCRIFAST
Type of DeviceLACRIMAL STENT
Manufacturer (Section D)
KANEKA CORP.
osaka
JA
Manufacturer Contact
masaharu inoue
546 fifth avenue
21st floor
new york, NY 10036
8005263522
MDR Report Key4669231
MDR Text Key5732107
Report Number9614654-2015-00005
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 04/01/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/01/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2017
Device Catalogue NumberLF-R105
Device LOT NumberKP104484
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer03/10/2015
Is The Reporter A Health Professional? Yes
Date Manufacturer Received03/04/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/01/2014
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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