MAUDE Adverse Event Report: QUEST MEDICAL, INC. LACRICATH LACRIMAL DUCT BALLOON CATHETER; LACRIMAL STENTS AND INTUBATION SETS

Model Number DCP315BIT

Device Problems Decrease in Pressure (1490); Material Rupture (1546)

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

Event Date 10/02/2015

Event Type  malfunction  

Manufacturer Narrative

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 reported an issue encountered with the lacrimal duct balloon catheter during use.It was reported that during a left side tear duct probing and irrigation procedure on a (b)(6) child, the balloon ruptured.As a result, the water drained out and the pressure was lost.The report stated the clinician removed the device and used another 3mm balloon catheter to complete the procedure.The report stated the pressure was at 8psi for 2 minutes when the alleged event occurred.The report stated the device will be returned to the manufacturer for analysis.There were no patient complications reported as a result of the alleged event.

Manufacturer Narrative

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.There were no devices of this same lot remaining in inventory for analysis.Final sterile lot is: 0483405j05.

• Brand Name: LACRICATH LACRIMAL DUCT BALLOON CATHETER
• Type of Device: LACRIMAL STENTS AND INTUBATION SETS
• 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 ; 9723326338
• MDR Report Key: 5193830
• MDR Text Key: 30453639
• Report Number: 1649914-2015-00080
• Device Sequence Number: 1
• Product Code: OKS
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/20/2018
• Device Model Number: DCP315BIT
• Device Lot Number: 048675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2015
• 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
• Patient Age: 2 YR