MAUDE Adverse Event Report: KANEKA CORP. LACRIFAST; LACRIMAL STENT

Catalog Number LR-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 03/03/2015

Event Type  malfunction  

Event Description

This device (larcrifast) was employed to treat epiphora due to lacrimal duct occlusion.The doctor inserted one of the lacrimal duct tube (colored in clear) into the occluded lacrimal duct with the bougie provided with this device inserting in the tube.It was found that the bougie penetrated out of the tue and the stainless steel ring mounted in the tip of the tube was missing.

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 colored in clear tube 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.Kp084262 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 the tube with the bougie inserted forcibly in the heavily occluded lesion, 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.

• Brand Name: LACRIFAST
• Type of Device: LACRIMAL 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 Key: 4669241
• MDR Text Key: 5622371
• Report Number: 9614654-2015-00006
• Device Sequence Number: 0
• Product Code: OKS
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• 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 Received: 04/01/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: LR-R090
• Device Lot Number: KP084262
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1