MAUDE Adverse Event Report: QUEST MEDICAL, INC LACRICATH LACRIMAL DUCT BALLOON CATHETER 3 MM; LACRIMAL DUCT CATHETER

Model Number LDC315T

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/08/2020

Event Type  malfunction  

Manufacturer Narrative

The device was discarded by the user and is not available for investigation.No patient complications have been reported.Quest will submit a follow-up report if additional information is received.

Event Description

A report was received from a customer regarding an alleged issue which occured during use of the device.The report states that the tip of the catheter broke off inside a patient's tear duct and wasn't recovered.

Manufacturer Narrative

An investigation could not be conducted as the device sample was not returned.The dhr was reviewed and no anomalies were seen.The root cause of the reported complaint condition is unknown.A review of the device picture received appears to show misuse of the product, e.G.Using it as a general probe before inflation, contrary to the device ifu which instructs users to pass a bowman probe down the nasolacrimal duct before use of the balloon catheter.

• Brand Name: LACRICATH LACRIMAL DUCT BALLOON CATHETER 3 MM
• Type of Device: LACRIMAL DUCT CATHETER
• Manufacturer (Section D): QUEST MEDICAL, INC; one allentown parkway; allen TX 75002
• MDR Report Key: 11167698
• MDR Text Key: 252007080
• Report Number: 1649914-2021-00001
• Device Sequence Number: 1
• Product Code: OKS
• Combination Product (y/n): N
• PMA/PMN Number: K113867
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: LDC315T
• Device Lot Number: 0575489M04
• Date Manufacturer Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1