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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

Catheter: catalog #: rx20025c, expiration date: 5/21/2017, serial #: (b)(4), manufacture date: 07/2014.Temperature sensor: catalog #: 72404221, expiration date: unknown, serial #: unknown, manufacture date: unknown.The catheter in question was returned for analysis.Functional testing found that the catheter performed within specifications.Visual inspection found nothing notable.The temperature sensor in question did not return for analysis.

Event Description

It was reported that the patient started bleeding after the thermatrx catheter was placed but before the heat treatment had begun.It was also indicated that a temperature sensor was giving the high drive voltage error during the same treatment.No additional patient complications were reported in relation to this event.

• 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: 4989791
• MDR Text Key: 22487493
• Report Number: 2183959-2015-00346
• 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
• Report Date: 07/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2015
• 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