MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) GENESYS HTA PROCERVA®; DEVICE, THERMAL ABLATION, ENDOMETRIAL

Model Number M006580210

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2017

Event Type  malfunction  

Manufacturer Narrative

The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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

This report pertains to one of two devices used during the same procedure.Manufacturer report# 3005099803-2017-03766 pertains to the first genesys hydrothermablation procerva procedure set and manufacturer report# 3005099803-2017-03767 pertains to the second genesys hydrothermablation procerva procedure set.It was reported to boston scientific corporation on (b)(6) 2017 that two genesys hydrothermablation procerva procedure sets were opened for use in a hydrothermablation (hta) procedure performed on (b)(6) 2017.According to the complainant, during preparation when they opened the genesys hydrothermablation procerva procedure set kit they noticed a hair inside it (mfr report# 3005099803-2017-03766).Another hydrothermablation procerva procedure set was opened (mfr report# 3005099803-2017-03767) and the same issue was noted.The procedure was completed with a third hydrothermablation procerva procedure set.There were no complication reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

Manufacturer Narrative

Visual analysis of the returned genesys hta procerva procedure set sheath revealed a presence of short hair inside the original tray.There was no physical damage noted on its original tray.The issue was noted during preparation and outside the patient and this was confirmed during the analysis of the returned unit.Dhr review was performed and no deviation was found.The issue was evaluated by the manufacturing engineering team and it was concluded that the issue did not occur within the manufacturing plant.During the process the product is inspected to ensure that the units are free of foreign matter according to the respective procedures.Based on all gathered information and condition of the returned device, the probable root cause is undeterminable.

Event Description

This report pertains to one of two devices used during the same procedure.Pertains to the first genesys hydrothermablation procerva procedure set and manufacturer report# 3005099803-2017-03767 pertains to the second genesys hydrothermablation procerva procedure set.It was reported to boston scientific corporation on (b)(6) 2017 that two genesys hydrothermablation procerva procedure sets were opened for use in a hydrothermablation (hta) procedure performed on (b)(6) 2017.According to the complainant, during preparation when they opened the genesys hydrothermablation procerva procedure set kit they noticed a hair inside it.Another hydrothermablation procerva procedure set was opened (mfr report# 3005099803-2017-03767) and the same issue was noted.The procedure was completed with a third hydrothermablation procerva procedure set.There were no complication reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: GENESYS HTA PROCERVA®
• Type of Device: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7120510
• MDR Text Key: 95770170
• Report Number: 3005099803-2017-03766
• 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,Followup
• Report Date: 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: M006580210
• Device Catalogue Number: 58021
• Device Lot Number: 20404995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2017
• 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