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

Model Number LDC213T

Device Problem Inflation Problem (1310)

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

Event Date 06/22/2017

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation.An inflator was used to attempt to inflate the device to 8atm; however, the device would not inflate.Visual examination of the balloon portion of the device confirmed a tear where the balloon attaches to the hypotube.The cause of the tear is unknown.The device history record for the lot was reviewed and no devices were rejected and no specific manufacturing yield issues were reported similar to the reported complaint condition.Quest medical, inc.Has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Quest medical, inc.Defers to the patient's physician regarding medical history.

Event Description

The hospital materials coordinator reported an issue encountered with the 2mm lacricath device during use.The report stated that during a procedure the balloon on the end of the stent once inflated did not hold after insertion.There were no patient complications reported as a result of the alleged issue.The device was returned to the manufacturer for evaluation.

• 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: 6833393
• MDR Text Key: 85306845
• Report Number: 1649914-2017-00074
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/14/2019
• Device Model Number: LDC213T
• Device Lot Number: 0517986U08
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2016
• 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): Required Intervention