MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GENESYS HTA PROCERVA; DEVICE, THERMAL ABLATION, ENDOMETRIAL

Model Number	M006580211
Medical Device Problem Codes	Fluid/Blood Leak (1250); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number.Therefore, the expiration and device manufacture dates are unknown.(b)(4).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 or Problem Description
It was reported to boston scientific corporation that genesys hta procerva procedure sets was used in a procedure performed on (b)(6) 2020.According to the complainant, the physician dialated to 23 fr and was assured that she got a good seal and did not see any significant fluid loss before initiating the ablation process.Six minutes into procedure, the physician stated that hot fluid rushed out and burned the patient's vagina.The physician decided to abort the procedure and begun cooling process.Reportedly, error message check for fluid loss appeared on the console.The patient was referred to burn physician to consult on burn site.

• Brand Name: GENESYS HTA PROCERVA
• Common Device Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10860333
• Report Number: 3005099803-2020-05541
• Device Sequence Number: 2521933
• Product Code: MNB
• UDI-Device Identifier: 08714729809463
• UDI-Public: 08714729809463
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 11/18/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: M006580211
• Device Catalogue Number: 58021
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 11/18/2020
• 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