MAUDE Adverse Event Report: UROLOGIX, INC TARGIS SYSTEM; MICROWAVE DELIVERY SYSTEM

Model Number 410092-001

Device Problems Decrease in Pressure (1490); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2014

Event Type  malfunction  

Event Description

Field service was contacted by a urologix tsr after he reported receiving a low pressure error approximately 10 minutes into a ctt procedure.The tsr said that the coolant bag was empty and he attempted to continue the procedure and while checking the location balloon, no water could be drawn out from the location balloon fill port.At that point, the procedure was stopped, the catheter was removed.The tsr stated that it appeared as though the location balloon had failed.The microwave power was being operated at approximately 30 watts during the procedure.The tsr said the catheter did not migrate because it was being held in position by the mds holder, so no patient injury had occurred.The catheter was changed and the ctt procedure was continuing without any additional errors.

Manufacturer Narrative

Failure mode: failure of the location balloon distal adhesive joint, allowing the coude tip to become dislodged and the location balloon to bleed out through the coude tip and deflate.Root cause: communication between the coolant inflow and location balloon partitions of the plastic handle.During treatment, the pump forced fluid into the location balloon until it built up enough pressure to blow the distal adhesive joint.Additionally, the complaint stated that a low pressure error was generated approximately 10 minutes into the procedure.The balloon failure likely did not occur until shortly before the low pressure error occurred.At the rate that the coolant was "leaking" into the location balloon, it would have only taken 1-2 minutes from the time of the adhesive joint failure for the fluid to drain out of the system (thus generating the low pressure error.).

• Brand Name: TARGIS SYSTEM
• Type of Device: MICROWAVE DELIVERY SYSTEM
• Manufacturer (Section D): UROLOGIX, INC; 14405 21st avenue n; minneapolis MN 55447
• Manufacturer (Section G): UROLOGIX, INC.; 14405 21st avenue n; minneapolis MN 55447
• Manufacturer Contact: hope przybilla ; 14405 21st avenue n; minneapolis, MN 55447 ; 7634048134
• MDR Report Key: 3632981
• MDR Text Key: 3985058
• Report Number: 2133936-2014-00001
• Device Sequence Number: 1
• Product Code: MEQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/30/2015
• Device Model Number: 410092-001
• Device Catalogue Number: 410092-001
• Device Lot Number: 130815MCA2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1