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

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.

• Brand Name: LACRIFAST
• Type of Device: LACRIMAL STENT
• Manufacturer (Section D): KANEKA CORP.; osaka ; JA
• Manufacturer Contact: masaharu inoue ; 546 fifth ave.; 21st floor; new york, NY 10036 ; 8005263522
• MDR Report Key: 4528469
• MDR Text Key: 18545538
• Report Number: 9614654-2015-00002
• 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: Other,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-R105
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/20/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2015
• 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 Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR