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

Model Number M006580210

Device Problems Device Alarm System (1012); Fluid/Blood Leak (1250)

Patient Problem Burn(s) (1757)

Event Date 09/09/2020

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the upn and lot number of the device.Therefore, the lot 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 Description

It was reported to boston scientific corporation that genesys hta procerva procedure sets was used in a procedure performed on an (b)(6) 2020.According to the complainant, the unit was giving fluid loss alarm three times and the physician was asked if there was fluid coming out of the cervix and she confirmed that no fluid was coming out and continue the procedure.Reportedly, after the third alarm went off the physician pulled out the scope without completing the flushing and cooling cycle and noticed that the patient has some vaginal burns.The patient was treated with silvadene.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Event Description

It was reported to boston scientific corporation that genesys hta procerva procedure sets was used in a procedure performed on an (b)(6) 2020.Reportedly, the procedure was done under general anesthesia and a tenaculum stabilizer was used.According to the complainant, the unit was giving fluid loss alarm three times and the physician was asked if there was fluid coming out of the cervix and she confirmed that no fluid was coming out and continue the procedure.Reportedly, after the third alarm went off the physician pulled out the scope without completing the flushing and cooling cycle and noticed that the patient has some vaginal burns.The patient was treated with silvadene.As of september 21, 2020, additional information was received stating that the patient was sent home after treatment and is now improving.

Manufacturer Narrative

Block h6: device problem code 1250 capture the reportable event of fluid leak.Patient code 1757 capture the reportable event of burn.Block h10: 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.

• Brand Name: GENESYS HTA PROCERVA
• Type of Device: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10552985
• MDR Text Key: 207507364
• Report Number: 3005099803-2020-04056
• Device Sequence Number: 1
• Product Code: MNB
• Combination Product (y/n): N
• PMA/PMN Number: P000040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2022
• Device Model Number: M006580210
• Device Catalogue Number: 58021
• Device Lot Number: 0025432175
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other