REZUM
Report
- Report Number
- 2124215-2026-02331
- Event Type
- Injury
- Date Received
- January 13, 2026
- Date of Event
- December 9, 2025
- Report Date
- January 13, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KNS
- UDI-DI
- 08714729992547
- PMA / PMN Number
- K191505
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
G4. PREMARKET/510(D): K190093, K191505. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BASED ON THE NATURE OF THE INFORMATION PROVIDED TO BSC, IT IS NOT POSSIBLE TO PERFORM A GOOD FAITH EFFORT TO OBTAIN ADDITIONAL INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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 USE 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.
IT WAS REPORTED THAT POST A WATER VAPOR THERAPY PROCEDURE, ONE WEEK AFTER THE CATHETER WAS REMOVED, ON THE FOLLOWING DAY, THE PATIENT EXPERIENCED UROSEPSIS. THE PATIENT WAS HOSPITALIZED AND TREATED WITH IV ANTIBIOTICS. THE PATIENT IS NOW FULLY RECOVERED. THE INFECTION WAS NOT CONTRIBUTED BY THE DEVICE BUT WAS POSSIBLY RELATED TO THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 123678 | REZUM | UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) | KNS | BOSTON SCIENTIFIC CORPORATION | M006D2201-003 | 08714729992547 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other| H |