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	06/14/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The surgical center materials manager reported an issue encountered with a lacrimal duct catheter during use.The report stated the device leaked.There were no patient complications reported as a result of the alleged issue.Another device was used to complete the procedure.The device was returned to the manufacturer for evaluation.See also 1649914-2017-00057 for first device.
Additional Manufacturer Narrative
Evaluation of the returned device found that insufficient glue was applied to attach the balloon to the catheter.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 CATHETER
• Common Device Name: LACRIMAL DUCT CATHETER
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• MDR Report Key: 6713215
• Report Number: 1649914-2017-00061
• Device Sequence Number: 1771804
• Product Code: OKS
• UDI-Device Identifier: 10634624810188
• UDI-Public: 10634624810188
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K113867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2017

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: 03/07/2020
• Device Model Number: LDC315T
• Device Lot Number: 0531747M06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/14/2017
• Supplement Date Received by Manufacturer: 06/14/2017
• Initial Report FDA Received Date: 07/13/2017
• Supplement Report FDA Received Date: 09/04/2017
• 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