MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (CE) HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM; DEVICE, THERMAL ABLATION, ENDOMETRIAL

Model Number	M00658001R0
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a genesys hydrothermablation endometrial ablation system was used in a hydrothermablation (hta) procedure performed on (b)(6) 2017.According to the complainant, during heating up phase of the procedure, the control unit started to smoke when the saline fluid leaked onto the machine while it powered up.The unit was immediately unplugged from the electrical.The procedure was not completed due to this event.There were no patient complications reported as a result of this event and the patient's condition at the conclusion of the procedure was reported to be fine.
Additional Manufacturer Narrative
Analysis of the returned genesys hydrothermablation endometrial ablation system revealed that there were no alarms, smoke or cassette leaking were observed during the test.The unit passed the functional feature test.As the reported problem was not duplicated during the testing of the genesys console, the most probable root cause is not confirmed.A review of the device history record (dhr) was performed and no deviations were found.A search of the complaint database revealed that no other complaints exist for the specified batch.
Event or Problem Description
It was reported to boston scientific corporation that a genesys hydrothermablation endometrial ablation system was used in a hydrothermablation (hta) procedure performed on (b)(6) 2017.According to the complainant, during heating up phase of the procedure, the control unit started to smoke when the saline fluid leaked onto the machine while it powered up.The unit was immediately unplugged from the electrical.The procedure was not completed due to this event.There were no patient complications reported as a result of this event and the patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM
• Common Device Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - FREMONT (CE); 47215 lakeview blvd; north dock; fremont CA 94538
• MDR Report Key: 6633332
• Report Number: 3005099803-2017-01830
• Device Sequence Number: 12177
• Product Code: MNB
• UDI-Device Identifier: 08714729809357
• UDI-Public: (01)08714729809357(11)20111128
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P000040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2017

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
• Operator of Device: Health Professional
• Device Model Number: M00658001R0
• Device Catalogue Number: 58001R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Initial Date Received by Manufacturer: 05/26/2017
• Supplement Date Received by Manufacturer: 06/13/2017
• Initial Report FDA Received Date: 06/12/2017
• Supplement Report FDA Received Date: 07/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1