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

Model Number M006580010

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2015

Event Type  malfunction  

Manufacturer Narrative

The exact age of the patient is unknown, however, it was reported the patient was over 18 years.The complainant indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event 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) 2015.According to the complainant, during the ablation phase of the procedure, smoke was noticed coming from the genesys hta control unit.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.The patient condition was reported to be "fine.".

• Brand Name: HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM
• Type of Device: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - FREMONT (CE); 47215 lakeview blvd; north dock; fremont CA 94538
• Manufacturer (Section G): BOSTON SCIENTIFIC - FREMONT (CE); 47215 lakeview blvd; north dock; fremont CA 94538
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5046236
• MDR Text Key: 24770160
• Report Number: 3005099803-2015-02388
• Device Sequence Number: 1
• Product Code: MNB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M006580010
• Device Catalogue Number: 58001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1