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

Model Number	58001
Medical Device Problem Codes	Installation-Related Problem (2965); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 a genesys hta controller was used to perform a hydrothermal ablation procedure performed on (b)(6) 2020.Reportedly, the patient was under anesthesia.According to the complainant, during procedure, the physician was priming the machine and an error message "cassette failed" appeared.A second cassette was used the physician was unable to gain pressure.The hta cassette was reprimed and it failed for the third time.The procedure was cancelled due to this event.There was no serious injury nor adverse patient effects reported as a result of this event.

• Brand Name: GENESYS HTA SYSTEM
• Common Device Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752 1242
• MDR Report Key: 10327276
• Report Number: 3005099803-2020-02990
• Device Sequence Number: 2890038
• Product Code: MNB
• UDI-Device Identifier: 08714729809326
• UDI-Public: 08714729809326
• Combination Product (Y/N): N
• Initial Reporter State: WY
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2020

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: 58001
• Device Catalogue Number: 58001
• Device Lot Number: GEN1223
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 07/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1