MAUDE Adverse Event Report: KANEKA CORPORATION LACRIFAST; LACRIMAL STENT

Catalog Number LF2-R105

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 10/10/2017

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).- 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 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) 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 obstructed lacrimal duct.While advancing the tube, the doctor felt strong resistance and gave up to further insert the tube, and he retrieved it out of the patient's lacrimal duct.When the actual device used was investigated, 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.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, osaka 530-8-288 ; JA 530-8288 ; 31814120
• MDR Report Key: 6986216
• MDR Text Key: 91103251
• Report Number: 3009761573-2017-00004
• 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: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: LF2-R105
• Device Lot Number: KP047292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2017
• 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: 86 YR