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

Model Number	M006580010
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and 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 on june 7, 2018 that a genesys hydrothermablation controller was used in a hydrothermablation (hta) procedure performed on (b)(6) 2018.According to the complainant, during ablation phase, when the fluid temperature heated to 80 degrees celsius and reached 100 degrees celsius, a faulty cassette alarm was detected.The staff tried to initiate cool down mode but the controller was not responding.A plastic burning smell was noted and smoke was coming out from where the cassette was engaged.The machine was restarted and the physician waited 5 minutes for fluid to cool down.A bulb system with room temperatue saline was used to irrigate the area.Thee procedure was aborted due to this event.There were no patient complications reported as a result of this event.The patient 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: 7657982
• Report Number: 3005099803-2018-02179
• Device Sequence Number: 1512693
• Product Code: MNB
• UDI-Device Identifier: 08714729809326
• UDI-Public: 08714729809326
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/07/2018

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: M006580010
• Device Catalogue Number: 58001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2018
• Initial Report FDA Received Date: 07/03/2018
• Patient Sequence Number: 1