MAUDE Adverse Event Report: KANEKA CORPORATION LACRIFAST; LACRIMAL STENT

Catalog Number LF2-R090

Device Problems Material Separation (1562); Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problem Device Embedded In Tissue or Plaque (3165)

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.- we originally found this information on 5/25/2017 in a preliminary program of (b)(6), scheduled in this july, by a title of presentation.We made an interview to the author of the presentation on 6/7/2017 to confirm the event subject to the presentation more in detail.According to the dr.Interviewed, the event occurred about one year before (in 2016) and the physician, who performed the actual procedure, was moved out of this facility.The dr.Interviewed provided us with the available information of the case described in this report.- the expiry of the device is for 3 years.As the lot no.Of the concerned device was not available, the device history records (dhr) of the devices manufactured since its first production in 2015 till the end of 2016, where the device concerned should be included, and confirmed that the device met its material, assembling and product specifications.- the physician in charge commented that this problem was not due to any device failure but to their procedural problem by making a false passage and not being able to retrieve the device appropriately.- we speculated the cause of torn off the tip of the tube and remained in the patient as follows: as described above in "describe event or problem", the tube insertion by using the bougie created a false passage in the occluded nasal duct.The tip portion was stuck tightly in the false passage, and was torn off by an excessive tensile force while the physician forcibly pulled the tube out of the patent.We determine, as commented by the physician in charge, the problem was caused not by any defect of the device but by the handling issue of the user.

Event Description

This device (lacrifast) was employed to treat the epiphora due to nasal duct blockage of a pediatric female patient.While inserting this lacrimal duct tube into the nasal duct, the physician realized that a false passage was created.The physician tried to remove the tube but the tube could not be pulled back.Accordingly, the physician made an incision of the lacrimal sac and pulled back the tube, and then, the tip of the tube was torn off and remained in the patient, since the tip of the tube was entered deep into and stuck in the tissues.The physician gave up to remove the remained tip portion out of the patient, and placed a new lacrimal duct tube in the nasal duct successfully 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: 6645805
• MDR Text Key: 77840359
• Report Number: 9614654-2017-00007
• 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: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LF2-R090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2017
• Initial Date FDA Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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