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 12/02/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was disposed and will not be returned 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 Description

It was reported to boston scientific corporation on (b)(6) 2019, that a genesys hta procerva procedure set was used in a hydrothermal ablation procedure in the uterine cavity performed on (b)(6) 2019.Reportedly, the procedure was done under general anesthesia.According to the complainant, during procedure, the physician noted that the patient's cervix was loose although well dilated.Two tenaculums and a ring forceps were used to acquire a tight cervical seal.A fluid loss alarm of three, fifteen and eighty three cubic centimeter per minute was noted during the case and the console shut down after the third alarm.The physician noted a leak from the patient's cervix and an external burn on the patient's labia and the posterior portion of the vagina.The burn was treated with silvadene cream.The procedure was cancelled due to this event.An additional attempt has been made to obtain follow up event details with no response from the clinician.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; 300 boston scientific way MA 01752
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 9529724
• MDR Text Key: 181578468
• Report Number: 3005099803-2019-06294
• Device Sequence Number: 1
• Product Code: MNB
• UDI-Device Identifier: 08714729809456
• UDI-Public: 08714729809456
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2021
• Device Model Number: M006580210
• Device Catalogue Number: 58021
• Device Lot Number: 0024379802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR