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

Model Number LDC315T

Device Problems Inflation Problem (1310); Device Operates Differently Than Expected (2913)

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

Event Date 03/24/2017

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 facility materials manager reported an issue encountered by the physician while using the lacrimal duct catheter.The report stated that the device would not remain inflated.The report stated that the catheter was removed and a second one was used to successfully complete the procedure.There were no patient complications reported as a result of the alleged issue.The catheter was returned to the manufacturer for evaluation.

Manufacturer Narrative

Because the complaint sample was a device included in a kit,, there were 2 possible lots of product it could have been.The other possible lot of product is lot 0523966n02 manufacture date 10/26/2016 exp 10/26/2019.Visual examination of the complaint sample found that it had been used.After decontamination, the device was inflated to 8atm.The device remained inflated during pressurization; however, once completed a leak was observed at the tip.The root cause is most likely inadequate adhesive to bond the balloon to the catheter body.The possible product lots were both manufactured prior to manufacturing process improvements implemented.

• 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
• 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: 6475986
• MDR Text Key: 72542026
• Report Number: 1649914-2017-00037
• Device Sequence Number: 1
• Product Code: OKS
• UDI-Device Identifier: 10634624810195
• UDI-Public: 10634624810195
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/15/2019
• Device Model Number: LDC315T
• Device Lot Number: 0521446S05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2019
• 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