MAUDE Adverse Event Report: QUEST MEDICAL INC LACRICATH LACRIMAL DUCT CATHETER

Model Number LDC315T

Device Problems Fluid/Blood Leak (1250); Inflation Problem (1310); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/25/2017

Event Type  malfunction  

Event Description

The surgical center's material management reported an issue encountered while using the lacricath lacrimal duct catheter.The report stated that the device malfunctioned when the physician attempted to inflate the catheter's balloon.The physician stated that the device leaked fluid, so he removed the catheter and completed the procedure using a crawford tube instead.There were no patient complications reported as a result of the alleged issue.The device was returned to the manufacturer for evaluation.

Manufacturer Narrative

The original report stated the device model to be ldc213t.Once the device was received and evaluated it was found to be model ldc315t.Device evaluation confirmed the reported complaint condition of the device leaking.Evaluation found that there was a tear in the balloon material.It is unknown where the tear originated from.There were no anomalies found in the dhr related to the reported complain condition.

• Brand Name: LACRICATH LACRIMAL DUCT CATHETER
• Type of Device: LACRIMAL DUCT CATHETER
• Manufacturer (Section D): QUEST MEDICAL INC; one allentown parkway; allen TX 75002
• Manufacturer (Section G): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• Manufacturer Contact: amy clendening-wheeler ; one allentown parkway; allen, TX 75002
• MDR Report Key: 6665980
• MDR Text Key: 78550676
• Report Number: 1649914-2017-00048
• Device Sequence Number: 1
• Product Code: OKS
• UDI-Device Identifier: 10634624810188
• UDI-Public: 10634624810188
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113867
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/29/2019
• Device Model Number: LDC315T
• Device Lot Number: 0526186D02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR