MAUDE Adverse Event Report: QUEST MEDICAL, INC LACRICATH LACIMAL DUCT CATHETER; LACRIMAL DUCT CATHETER

Model Number LDC213T

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 09/01/2017

Event Type  malfunction  

Manufacturer Narrative

The complaint sample was not returned for investigation.A dhr review as well as a process review was conducted and no anomalies were identified.No similar complaint was identified from a 24 month complaint history review conducted on this device.The lot complained about had been depleted,as such there was no available sample from that lot for investigation.3 samples of a similar device from another lot were tested to determine the force required to break the hypotube and balloon.The first sample disconnected from the hub.

Event Description

The physician reported an issue encountered with the device during use.The physician stated she was using the device on a child and when she inserted the catheter into the nasolacrimal duct, she couldn't get it all the way down the duct.The report continued that she attempted to pull it out and when she did, the tip of the catheter and balloon broke off inside the patient about 1.5 cm above the tip of the first black marker band.The physician said this occurred prior to inflation.The physician said she irrigated the patient, but believes the fragment could still be in the patient's eye and had ordered x-rays on the patient to confirm.The device will not return for evaluation.Follow up with the physician found that the patient is doing well and are planning a ct.No additional information is available at this time.

• Brand Name: LACRICATH LACIMAL DUCT CATHETER
• 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: tosan onosode ; one allentown parkway; allen, TX 75002 ; 9723326338
• MDR Report Key: 7205985
• MDR Text Key: 168719872
• Report Number: 1649914-2017-00078
• Device Sequence Number: 1
• Product Code: OKS
• UDI-Device Identifier: 10634624810188
• UDI-Public: 10634624810188
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LDC213T
• Device Lot Number: 053566
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention