MAUDE Adverse Event Report: KANEKA CORPORATION LACRIFAST; LACRIMAL STENT

Catalog Number LF2-R090

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 11/03/2016

Event Type  malfunction  

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: there was a hole, from where the bougie was thought to penetrate out, in the sidewall of the tube (colored in clear) where a stainless steel ring was mounted, and the ring was dismounted and missing.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 forcibly in the occluded lacrimal duct, 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 bougie with the ring out of the tube.This report is delayed because it was sent to the emdr test instead of production.

Event Description

This device (lacrifast) was employed to treat the epiphora due to lacrimal duct obstruction.The doctor inserted one of the lacrimal duct tube (colored in clear) into the lacrimal duct.While advancing the tube, the doctor felt that the bougie penetrated out of the tube and retrieved it out of the patient's lacrimal duct.He used another lacrifast and completed 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-city,, osaka 530-8-288 ; JA 530-8288 ; 4613072
• MDR Report Key: 6203742
• MDR Text Key: 63264135
• Report Number: 9614654-2016-00023
• 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: 11/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: LF2-R090
• Device Lot Number: KP046378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR