MAUDE Adverse Event Report: KANEKA CORPORATION LACRIFAST; LACRIMAL STENT

Catalog Number LF2-R90

Device Problems Material Puncture/Hole (1504); Material Separation (1562); Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/05/2017

Event Type  malfunction  

Manufacturer Narrative

- the concerned device "lacrifast" is not distributed in the us under this device name, but is identical to the device "lacriflow lacrimal stent" distributed in the us under 510(k) # k120886.- the actual device used was returned and investigated: no deformation or damage was found in the pair of tubes except for missing the stainless-steel ring mounted in the tip of the tube (colored in clear).- the ring's whereabouts was not confirmed during the procedure in this eye clinic, and accordingly, the missing stainless steel ring might have been remaining in the patient body.- 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 in the tube forcibly in the completely occluded nasal duct, excessive mechanical force was loaded on the ring, where the tip of the bougie touched, and the bougie together with the ring penetrated out of the opening duct in the tip of the tube.

Event Description

This device "lacrifast", the lacrimal duct tube, was employed to treat the epiphora due to nasal duct complete occlusion.The doctor tried but failed in opening the occluded nasal duct by inserting a nasal endoscope.Then, he inserted one of the tube (colored in clear) of this device into the nasal duct directly by using the bougie included in this device.While advancing the tube, the doctor felt that the bougie penetrated out of the tube and retrieved it from the patient and found that the stainless-steel ring mounted in the tip of the tube was missing.He used another lacrifast to complete the operation.

• Brand Name: LACRIFAST
• Type of Device: LACRIMAL STENT
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; nakanoshima, kita-ku; osaka, osaka 530-8 288; JA 530-8288
• Manufacturer Contact: kazuhiko inoue ; 2-3-18; nakanoshima,kita-ku; osaka, osaka 530-8-288 ; JA 530-8288 ; 31814120
• MDR Report Key: 6666130
• MDR Text Key: 78396113
• Report Number: 9614654-2017-00012
• 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: 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: LF2-R90
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2017
• 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