MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION REZUM; UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number D2201

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/27/2023

Event Type  Injury  

Event Description

It was reported that the patient was enrolled in the rezum vapeur rct study on 08jun2023.At the baseline physical examination, the patient had a cardiovascular finding of a stent iva moyenne.The patient underwent a water vapor therapy procedure on (b)(6) 2023 under anesthesia.The patient was also prescribed prophylactic antibiotics.When preparing the delivery device for the procedure, error 241 (booting failure) occurred.The delivery device was not used due to the error received, so the delivery device was replaced.The patient received one treatment in the right lobe, one treatment in the left lobe, and one treatment in the median lobe.The procedure was completed successfully.The patient was discharged with an indwelling catheter which was removed by a nurse at the patient's home on (b)(6) 2023.Additional information from the site noted that the event had led to a serious adverse event; however, details regarding the details/nature of the adverse event has not been provided.

Manufacturer Narrative

There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms are a known risk associated with implant of these devices as indicated in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device 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.At the baseline physical examination, the patient had a cardiovascular finding of a stent iva moyenne.The patient underwent a water vapor therapy procedure on (b)(6) 2023 under anesthesia.The patient was also prescribed prophylactic antibiotics.When preparing the delivery device for the procedure, error 241 (booting failure) occurred.The delivery device was not used due to the error received, so the delivery device was replaced.The patient received one treatment in the right lobe, one treatment in the left lobe, and one treatment in the median lobe.The procedure was completed successfully using the second delivery device.The patient was discharged with an indwelling catheter which was removed by a nurse at the patient's home on (b)(6) 2023.Additional information from the site noted that the event had led to a serious adverse event; however, details regarding the details/nature of the adverse event has not been provided.

Manufacturer Narrative

Additional information received via ai states the serious adverse event was reported by mistake.The patient did not experience any serious adverse events.The procedure was completed successfully.The event no longer meets reporting criteria.There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms are a known risk associated with implant of these devices as indicated in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device 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.At the baseline physical examination, the patient had a cardiovascular finding of a stent iva moyenne.The patient underwent a water vapor therapy procedure on (b)(6) 2023 under anesthesia.The patient was also prescribed prophylactic antibiotics.When preparing the delivery device for the procedure, error 241 (booting failure) occurred.As a result, priming was difficult/failed.The delivery device was not used due to the error received, so the delivery device was replaced.The patient received one treatment in the right lobe, one treatment in the left lobe, and one treatment in the median lobe.The procedure was completed successfully using the second delivery device.The patient was discharged with an indwelling catheter which was removed by a nurse at the patient's home on (b)(6) 2023.Additional information from the site noted that the event had led to a serious adverse event; however, details regarding the details/nature of the adverse event has not been provided.Subsequent additional information received clarified that the previously reported serious adverse event was reported by mistake.The patient did not experience a serious adverse event.

• Brand Name: REZUM
• Type of Device: UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT 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 5798
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18021080
• MDR Text Key: 326723024
• Report Number: 2124215-2023-59753
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D2201
• Device Catalogue Number: D2201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2023
• Initial Date FDA Received: 10/27/2023
• Supplement Dates Manufacturer Received: 11/02/2023; 11/27/2023
• Supplement Dates FDA Received: 11/22/2023; 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 90 KG