MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS THERMATRX TMX-3000 OFFICE THERMOTHERAPY; SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BPH), THERMOTHERAPY

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

It was reported that two catheters had balloon leak issues during treatment.No patient complications were reported in relation to this event.

Manufacturer Narrative

Additional information: catheter #1, catalog #: rx20020c.Catheter #2, catalog#: rx20025c.

Manufacturer Narrative

Two thermatrx catheters were returned and analyzed.Catheter #1 performed within specifications and appeared normal.Catheter #2 had a pinhole size leak in the balloon that appeared to be the result of a sharp instrument.The balloon was not stretched or distorted, so it appears that the leak did not occur while the balloon was inflated.The connector at the end of one temperature sensor sleeve is missing.It is not known when this may have occurred.

• Brand Name: AMS THERMATRX TMX-3000 OFFICE THERMOTHERAPY
• Type of Device: SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BPH), THERMOTHERAPY
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: sharon zurn ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 4194826
• MDR Text Key: 5152928
• Report Number: 2183959-2014-00470
• Device Sequence Number: 1
• Product Code: MEQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000043
• 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: 10/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other