MAUDE Adverse Event Report: KANEKA CORP. LACRIFAST; LACRIMAL STENT

Catalog Number LF-R090

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

Patient Problems No Consequences Or Impact To Patient (2199); Excessive Tear Production (2235); Device Embedded In Tissue or Plaque (3165)

Event Date 06/11/2014

Event Type  malfunction  

Event Description

This device (lacrifast), the lacrimal duct tube, was employed to treat epiphora due to obstructions in the lacrimal duct of the patient.We got the info about this event when we interviewed with the doctor, and the actual device involved in the event was disposed of in the clinic.According to the doctor, she tried to insert and place this device into the patient's lacrimal duct.Since the doctor felt a stronger resistance than usual during the insertion of this device, she pulled it out of the patient's lacrimal duct and found that a stainless steel ring mounted in the distal tip of this device was missing.A new lacrimal duct tube from a different mfr was placed in the lesion.

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 concerned device involved in the reported event was disposed of in the clinic and was not available for our further investigation.The lot # of the device was unk.As a possible cause of dropping off the ring during use, we speculate as follows: when the doctor tried to insert and advance this device through the lacrimal passage of the patient, excessive mechanical force was loaded in the distal tip of the device where the ring was mounted and the ring was finally dismounted to drop off out of the device.Doctor's comment: when i tried to insert this device into the patient's lacrimal duct, i felt a heavy resistance due probably to heavily occluded lesion.No health harm or aftereffect of the event was seen on the patient.No worsening of the lacrimal duct obstruction, inflammation of the lacrimal duct, or worsening of the epiphora was seen in about 3 weeks after the event.

• Brand Name: LACRIFAST
• Type of Device: LACRIMAL STENT
• Manufacturer (Section D): KANEKA CORP.; osaka ; JA
• Manufacturer Contact: masaharu inoue ; 546 fifth ave 21st floor; new york, NY 10036 ; 8005623522
• MDR Report Key: 4008357
• MDR Text Key: 4778228
• Report Number: 9614654-2014-00008
• 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: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LF-R090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2014
• 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 Age: 72 YR