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

Model Number	LDC315T
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/24/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: LACRIMAL DUCT CATHETER
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• MDR Report Key: 6475986
• Report Number: 1649914-2017-00037
• Device Sequence Number: 11098823
• Product Code: OKS
• UDI-Device Identifier: 10634624810195
• UDI-Public: 10634624810195
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K113867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2017

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: 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
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/24/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2017
• Supplement Report FDA Received Date: 05/09/2017
• 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