MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION REZUM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number G2200

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/24/2023

Event Type  malfunction  

Event Description

It was reported that the patient was enrolled in the rezum vapeur rct study on (b)(6) 2023.The patient was scheduled to undergo a water vapor therapy procedure on (b)(6) 2023 under anesthesia.During the procedure, error 275 (syringe water fill error) was received.The customer was not able to resolve the error.The procedure was then rescheduled.This event is being reported for an aborted/cancelled procedure with a patient under general anesthesia.

Manufacturer Narrative

The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available, the cause that contributed to the reported event cannot be established; a conclusion code of cause not established was assigned to this investigation.

Event Description

It was reported that the patient was enrolled in the rezum vapeur rct study on (b)(6) 2023.The patient was scheduled to undergo a water vapor therapy procedure on (b)(6) 2023 under anesthesia.During the procedure, error 275 syringe water fill error was received.The customer was not able to resolve the error.The procedure was then rescheduled.Additional information received states the patient subsequently underwent the water vapor therapy procedure on (b)(6) 2023 under anesthesia.The patient was given 1 treatment in the right lobe, 1 treatment in the left lobe, and 1 treatment in the medial lobe.The procedure was completed without any adverse events or device issues.The patient was discharged with an indwelling catheter which was later removed at the patient's home on (b)(6) 2023.This event is being reported for an aborted/cancelled procedure with a patient under general anesthesia.

• Brand Name: REZUM
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17460605
• MDR Text Key: 320794135
• Report Number: 2124215-2023-41500
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K180237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G2200
• Device Catalogue Number: G2200
• Device Lot Number: 0000003248
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2023
• Initial Date FDA Received: 08/04/2023
• Supplement Dates Manufacturer Received: 11/27/2023
• Supplement Dates FDA Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2016
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male