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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 03/05/2015
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 tubes (colored in clear) into the heavily occluded lacrimal duct with the bougie provided with this device inserting in the tube. Since the doctor 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 and the stainless steel ring mounted in the tip of the tube was missing. The doctor checked by a computed tomography (ct) scan, and found the ring was in the pt's nasolacrimal duct.

 
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 510 (k) #k120886. The actual device used was returned and investigated: the stainless steel ring mounted in the tip of the tube (colored in clear) was dismounted and missing. There was an injury penetrating the wall of the tube where the ring was mounted. 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. Kp114249 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 tried to insert and advance as follows: when the doctor 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 where the ring was mounted, and further pushing the bougie resulted in dismounting the ring and penetration of the ring with the bougie 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. (FOREIGN MANUFACTURER)
Manufacturer Contact
masaharu inoue
546 fifth avenue
21st floor
new york, NY 10036
8005263522
MDR Report Key4669230
MDR Text Key5605531
Report Number9614654-2015-00004
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
1 Patient Was 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 Date10/31/2017
Device Catalogue NumberLF-R090
Device LOT NumberKP114249
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer03/10/2015
Is The Reporter A Health Professional? Yes
Date Manufacturer Received03/05/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/01/2014
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: 04/01/2015 Patient Sequence Number: 1
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