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

Model Number	LDC213T
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/04/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The clinic reported an issue with a lacrimal duct catheter during a procedure.The report stated that the alleged event occurred during a dacroplasty procedure and was inserted into the patient at the time.The report stated that the balloon portion of the device leaked and would not maintain pressure.As a result of the alleged issue, the device was removed and another one was used to successfully complete the procedure.There were no patient complications reported as a result of the alleged issue.The device was returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
The sample was examined visually and functionally with no anomalies found.The device performed per specification with no leakage.The device history records for the possible lots were 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
• Common Device Name: LACRIMAL STENTS AND INTUBATION SETS
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• MDR Report Key: 6295147
• Report Number: 1649914-2017-00003
• Device Sequence Number: 540586
• Product Code: OKS
• UDI-Device Identifier: 10634624810188
• UDI-Public: 10634624810188
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2017

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 Model Number: LDC213T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/05/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/01/2017
• Supplement Report FDA Received Date: 02/06/2017
• 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