MAUDE Adverse Event Report: KANEKA CORPORATION LACRIFAST; LACRIMAL STENT

Catalog Number LF2-R105

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/10/2017

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 not returned.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.- the device history record (dhr) of the lacrifast with lot no.Kp126196 was reviewed and no nonconformity or abnormality was found in its manufacturing processes.The device met its material, assembling and product specifications.- as a possible cause of dropping off the stainless steel ring during the use, we speculate as follows: when the doctor tried to decannulate the sheath to place this device in the patient's lacrimal duct by the g-sgi technique, an excessive mechanical force was loaded to the ring mounted portion, and the ring with the bougie penetrated out of the tip of the tube.

Event Description

This device (lacrifast) was employed to treat the epiphora due to lacrimal duct obstruction of a female patient.The doctor pre-opened the lacrimal duct by using a sheath.Then, he inserted one of the pair of lacrimal duct tubes into the sheath, that was pre-inserted in the lacrimal duct, by using the g-sgi (goto-sheath guided intubation) technique.While decannulating the sheath from the lacrimal duct, he felt a strong resistance.He retrieved the sheath and lacrifast out of the patient's lacrimal duct, and found 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: 6515164
• MDR Text Key: 73457210
• Report Number: 9614654-2017-00005
• 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: 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: LF2-R105
• Device Lot Number: KP126196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2016
• 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