MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Rezum; Unit, Electrosurgical Endoscopic (With Or Without Accessories)

Model Number	M006D2201-003
Medical Device Problem Codes	Premature Activation (1484); Retraction Problem (1536); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a convective radiofrequency water vapor thermal therapy, after inserting the device into the patient, the needle deployed and misfired steam.After this happened, the needle would then not retract.The physician had to then pull the nose cone pin out of the device to manually retract the needle from the patient.The procedure was completed using another delivery device.There were no patient complications.
Additional Manufacturer Narrative
G4: pma/510(k) # field on 3500a form is k190093, k191505 - reported here as pma # exceeded character limit for designated field.

• 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; 4100 hamline avenue north; saint paul MN 55112 -579
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 50805061
• Report Number: 2124215-2026-49705
• Device Sequence Number: 10544486
• Product Code: KNS
• UDI-Device Identifier: 08714729992547
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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
• Operator of Device: Health Professional
• Device Model Number: M006D2201-003
• Device Catalogue Number: M006D2201-003
• Device Lot Number: 0039669434
• 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: 08/20/2026
• Initial Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 05/29/2026
• 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
• Patient Sex: Unknown