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

Model Number M00658001R0

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2017

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 was unable to provide the suspect device serial number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.The device has not been received for analysis; 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) 2017.According to the complainant, during procedure, error 86 was displayed and the console starts smoking.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.

Manufacturer Narrative

One genesys hydrothermablation (hta) endometrial ablation system was returned for evaluation.Visual inspection revealed that there was no visible damage noted on the returned device.The unit passed cis-genesys hta functional test and no alarms or error 86 were observed during the test.The eeprom data was downloaded from the unit and an "error 86" alarm occurred on (b)(6) 2017 was captured.As the reported problem was not duplicated during the testing of the genesys console, the most probable root cause is undeterminable.A review of the device history record (dhr) was performed; no anomalies were noted.A search of the complaint database revealed that no similar complaints exist for the specified lot.

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) 2017.According to the complainant, during procedure, error 86 was displayed and the console starts smoking.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.

• Brand Name: HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM
• Type of Device: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; north dock; marlborough MA 01752
• 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: 6776328
• MDR Text Key: 82126017
• Report Number: 3005099803-2017-02301
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00658001R0
• Device Catalogue Number: 58001R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1