MAUDE Adverse Event Report: QUEST MEDICAL, INC. LACRIMAL DUCT BALLOON CATHETER, 5MM; LACRIMAL STENTS AND INTUBATION SETS

Model Number DCR508UNI

Device Problem Burst Container or Vessel (1074)

Patient Problem No Information (3190)

Event Date 06/10/2015

Event Type  Injury  

Event Description

The physician reported he encountered an issue with the balloon catheter during a procedure.He stated that the balloon burst during the attempt to inflate while inserted in the lacrimal duct.He said the procedure was for a primary dcr, and that the device appeared fine prior to the burst.The physician stated this was his first attempt at using this model device for a primary dcr, but has used it for revisions with no problems.He said his technician, experienced with the use of this equipment, noted the gauge did not display the normal readings.The physician stated he thought it was an older model of the balloon catheter.There was no lot number provided and it is unknown if the device will be returned to the manufacturer for analysis.There was no patient information provided and it is unknown what steps the physician took as a result of the reported event.Multiple attempts to obtain additional information from the physician have been unsuccessful.

Manufacturer Narrative

The physician reported that the device model may be the older model device.No lot information was provided and it is unknown if the device will return for evaluation.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.

• Brand Name: LACRIMAL DUCT BALLOON CATHETER, 5MM
• 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: 4891727
• MDR Text Key: 6069517
• Report Number: 1649914-2015-00054
• Device Sequence Number: 1
• Product Code: OKS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K935233
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: DCR508UNI
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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