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

Model Number 410092-001

Device Problem Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/15/2014

Event Type  malfunction  

Event Description

During treatment, holes in balloon inflation port became evident.

Manufacturer Narrative

Based on the initial location balloon failure reported, a follow-up call was placed with the urologix application specialist to obtain additional description of the failure.The application specialist stated that he had to keep filling the coolant bag throughout the treatment because of coolant leaking from a hole in the handle.He clarified that it was not the locating balloon.He further described that the coolant bag drained repeatedly and he kept refilling it.The dr.Had him change out the catheter and the treatment was completed.The tag indicated low coolant errors and 11 minutes of treatment time.Coolant was run through the catheter and the coolant leaked from a hole in the handle.Failure analysis included visual inspection and evaluation of the dye fill, resection of the location balloon and opening of handle valves.Failure analysis revealed coolant leaking from the coolant infill port into the location balloon through the handle.The leak path was created by an incomplete adhesive fill at the proximal-most annular handle fill.During a treatment, this handle cross-talk condition may have caused the location balloon to overfill and rupture, leading to a low pressure error.Although this failure mode may have caused a rupture in the location balloon, the system pressure monitor will sense this condition and cease microwave delivery almost immediately.Therefore, patient injury is unlikely to occur as a result of this condition.

• 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: 3805650
• MDR Text Key: 4370896
• Report Number: 2133936-2014-00002
• 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: 05/12/2014

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
• Device Operator: Physician
• Device Expiration Date: 12/11/2015
• Device Model Number: 410092-001
• Device Catalogue Number: 410092-001
• Device Lot Number: 121113MCA2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/15/2014
• Initial Date FDA Received: 05/12/2014
• 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