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

Model Number	LDC315T
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/25/2017
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: LACRIMAL DUCT CATHETER
• Manufacturer (Section D): QUEST MEDICAL INC; one allentown parkway; allen TX 75002
• MDR Report Key: 6665980
• Report Number: 1649914-2017-00048
• Device Sequence Number: 1723679
• Product Code: OKS
• UDI-Device Identifier: 10634624810188
• UDI-Public: 10634624810188
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K113867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2017

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
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/25/2017
• Supplement Date Received by Manufacturer: 05/25/2017
• Initial Report FDA Received Date: 06/24/2017
• Supplement Report FDA Received Date: 07/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR