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

Model Number	58021
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The exact date of the event is unknown.The provided event date, (b)(6) 2020, was chosen as a best estimate based on the date that the manufacturer became aware of the event, 08/24//2020.(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 on august 24, 2020 that a genesys hta procedure set was used in a procedure performed on an unknown date.Reportedly, the patient had recurrent bleeding, polyp, and adenomyosis.According to the complainant, during the procedure, the patient was in the lithotomy position, and a weighted speculum was placed to the posterior fourchette.The hysteroscope was inserted into the cavity with some difficulty due to the active bleeding.The physician proceeded, completed dilation and curettage, and specimen was sent to pathology.The physician started the hta procedure, and after 3 minutes into ablation, the machine gave a safety alarm of leaking fluid or uterine expansion.The procedure had to be aborted.The patient was given paracervical block with epi to help with the bleeding, and pain.The patient condition after the procedure was reported to be stable.Reportedly, the patient will be reviewed by the physician after 2 weeks.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• 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: 10553109
• Report Number: 3005099803-2020-03981
• Device Sequence Number: 14239452
• Product Code: MNB
• UDI-Device Identifier: 08714729809456
• UDI-Public: 08714729809456
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/18/2020

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 Expiration Date: 03/26/2021
• Device Model Number: 58021
• Device Catalogue Number: 58021
• Device Lot Number: 0023633092
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 09/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1