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

Model Number M006580210

Device Problem Fluid/Blood Leak (1250)

Patient Problem Burn(s) (1757)

Event Date 10/31/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, 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 uterus performed on (b)(6) 2019.According to the complainant, during procedure, the physician noted some fluid leaking from the patient's cervix during ablation cycle.The physician removed the sheath causing an external burn to the patient.Reportedly, no fluid loss alarm was noted on the console.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.An additional attempt has also 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; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 9576272
• MDR Text Key: 174561460
• Report Number: 3005099803-2020-00037
• 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: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2021
• Device Model Number: M006580210
• Device Catalogue Number: 58021
• Device Lot Number: 0023182550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2019
• 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): Other