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

Model Number	M006580010
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.The device has not been received 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 or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Associated mfr report #3005099803-2017-03936 pertains to the genesys hydrothermablation procerva procedure set.It was reported to boston scientific corporation on november 29, 2017 that a genesys hydrothermablation endometrial ablation system was used in a hydrothermablation (hta) procedure performed on (b)(6) 2017 under general anesthesia.According to the complainant, around three minutes into the ablation, the water was seen gushing out of the cervix resulting in the cervix and vagina being burned.They took four liters of saline and poured it over the burnt area to cool it down.It was treated with burn cream after they had cooled it down.Patient was then sent home.***additional information received on december 21, 2017*** reportedly, the console did not give any alarm or error message upon the occurrence of a cervical leak.***additional information received on january 8, 2018*** reportedly, the console has not been used since the event.The patient is reported to have "healed okay.".
Additional Manufacturer Narrative
A visual examination of the returned device revealed that the genesys console appeared to be in fair condition.The genesys hta procerva procedure set was not returned with the console.The unit passed the genesys hta functional feature test with no cassette error or fluid loss alarms observed.There was evidence that the console works as intended.However, a review of the eeprom data found that the yellow bar detected the fluid loss and trigger fluid loss alarm greater than 10ml.There was evidence of ¿fluid loss detected¿ that occurred on (b)(6) 2017 observed in the downloaded eeprom data.This confirms the fluid loss complaint.Since patient thermal injury is a possible adverse event of the hta procedure as indicated in the dfu, the most probable root cause classification for the clinical failure mode (patient-burn) is anticipated procedural complication.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.A labeling review was performed, and from the information available this device was used per the directions for use (dfu) / product label.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Associated mfr report pertains to the genesys hydrothermablation procerva procedure set.It was reported to boston scientific corporation on (b)(6) 2017 that a genesys hydrothermablation endometrial ablation system was used in a hydrothermablation (hta) procedure performed on (b)(6) 2017 under general anesthesia.According to the complainant, around three minutes into the ablation, the water was seen gushing out of the cervix resulting in the cervix and vagina being burned.They took four liters of saline and poured it over the burnt area to cool it down.It was treated with burn cream after they had cooled it down.Patient was then sent home.Additional information received on december 21, 2017.Reportedly, the console did not give any alarm or error message upon the occurrence of a cervical leak.Additional information received on january 8, 2018.Reportedly, the console has not been used since the event.The patient is reported to have "healed okay.".

• Brand Name: HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM
• Common Device Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela CA ; CS
• MDR Report Key: 7181794
• Report Number: 3005099803-2018-00036
• Device Sequence Number: 10799031
• Product Code: MNB
• UDI-Device Identifier: 08714729809326
• UDI-Public: 08714729809326
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2018
• Initial Date Received by Manufacturer: 12/21/2017
• Supplement Date Received by Manufacturer: 02/23/2018
• Initial Report FDA Received Date: 01/11/2018
• Supplement Report FDA Received Date: 03/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other