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

Model Number	D2201
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after the water vapor thermal therapy procedure four patients experienced an infection, one of the patients developed sepsis several days after the indwelling catheter was removed, therefore was admitted to the intensive care unit (icu), two patients were admitted to hospital with severe infection and were treated with intravenous antibiotics, the last patient required oral antibiotics.All the four patients were reported as recovered after these events.Boston scientific has been unable to obtain additional information despite good faith efforts.This report captures one of patients that experienced a serious infection and went to hospital where was treated with intravenous antibiotics (iv ab's).
Additional Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date, 07/01/2024, was chosen as the best estimate based on the date that the manufacturer became aware of the event, 07/12/2024.Related reports: 2124215-2024-46442 - reports the patient that experienced sepsis and received intensive care.2124215-2024-46445 - reports the patient that when to hospital and was treated with intravenous antibiotics.2124215-2024-46446 - reports the patient that required oral antibiotics.

• Brand Name: REZUM
• Common Device Name: 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
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19913621
• Report Number: 2124215-2024-46444
• Device Sequence Number: 8337029
• Product Code: KNS
• UDI-Device Identifier: 00855357006010
• UDI-Public: 00855357006010
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K180237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/05/2024

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
• Operator of Device: Health Professional
• Device Model Number: D2201
• Device Catalogue Number: D2201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 08/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male