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

Model Number M006580210

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2018

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device has been 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 july 18, 2018 that a genesys hta procerva procedure set was used during a hydrothermal ablation procedure in the uterus performed on (b)(6) 2018.According to the complainant, during the procedure, the physician accidentally punctured the procedure sheath with the tenaculum during seal integrity check.The fluid started to leak out and a fluid loss alarm occurred.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.

Manufacturer Narrative

Updated based on additional information received that the correct bsc aware date was on july 16, 2018.

Event Description

It was reported to boston scientific corporation on (b)(6) 2018 that a genesys hta procerva procedure set was used during a hydrothermal ablation procedure in the uterus performed on (b)(6) 2018.According to the complainant, during the procedure, the physician accidentally punctured the procedure sheath with the tenaculum during seal integrity check.The fluid started to leak out and a fluid loss alarm occurred.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.Additional information received on 13aug2018.The correct bsc aware date was on july 16, 2018.

Manufacturer Narrative

Updated based on additional information received that the correct bsc aware date was on july 16, 2018.

Event Description

It was reported to boston scientific corporation on (b)(6) 2018 that a genesys hta procerva procedure set was used during a hydrothermal ablation procedure in the uterus performed on (b)(6) 2018.According to the complainant, during the procedure, the physician accidentally punctured the procedure sheath with the tenaculum during seal integrity check.The fluid started to leak out and a fluid loss alarm occurred.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.Additional information received on 13aug2018.The correct bsc aware date was on july 16, 2018.

• 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
• MDR Report Key: 7756735
• MDR Text Key: 116232024
• Report Number: 3005099803-2018-02514
• Device Sequence Number: 1
• Product Code: MNB
• UDI-Device Identifier: 08714729809456
• UDI-Public: 08714729809456
• 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: 08/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: M006580210
• Device Catalogue Number: 58021
• Device Lot Number: 19949656
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1