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

Model Number LDC213T

Device Problem Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2015

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 physician's office reported an issue encountered with the lacrimal duct balloon catheter device during use.They reported the device would not inflate.The report stated this was observed during the procedure.As a result of the alleged event, the physician changed out devices and successfully completed the procedure.There were no patient complications reported as a result fo the alleged event.The device was returned to the manufacturer for evaluation.

Manufacturer Narrative

Visual inspection under magnification while using water-filled inflator identified a lead at the bonding site of the balloon to the catheter.Uv adhesive was not sufficiently added to that area.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.

• 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: 5021178
• MDR Text Key: 24686943
• Report Number: 1649914-2015-00059
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/10/2018
• Device Model Number: LDC213T
• Device Lot Number: 0482565J03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2015
• 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