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

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.

• Brand Name: LACRIFAST
• Type of Device: LACRIMAL 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 Key: 4528468
• MDR Text Key: 5361086
• Report Number: 9614654-2015-00001
• Device Sequence Number: 1
• Product Code: OKS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• 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 Received: 02/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LF-R090
• Device Lot Number: KP094404
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/20/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2015
• 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
• Patient Sequence Number: 1