REZUM
Report
- Report Number
- 2124215-2024-36913
- Event Type
- Injury
- Date Received
- June 18, 2024
- Date of Event
- May 30, 2024
- Report Date
- July 1, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KNS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ALAMRI N A, EID K, ALSHEHRI M (DECEMBER 05, 2023) DEVELOPMENT OF A PROSTATIC URETHRAL CYST AFTER REZUM CAUSING PERSISTENT LOWER URINARY TRACT SYMPTOMS. CUREUS 15(12): E49969. DOI 10.7759/CUREUS.49969. CORRECTION TO FIELD H6. PATIENT CODES. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT REPORTED COMPLAINT COULD NOT BE CONFIRMED, DUE TO THE DEVICE DID NOT RETURN. THERE WAS NO DEVICE AVAILABLE FOR ANALYSIS AND THERE WAS NO REPORT OF A DEVICE PERFORMANCE ALLEGATION DURING TREATMENT. THE PATIENT SYMPTOMS OF DYSURIA, URINARY URGENCY AND INFLAMMATION ARE A KNOWN INHERENT RISK OF DEVICE USE AS STATED IN THE INSTRUCTIONS FOR USE. BASED ON ALL THE INFORMATION AVAILABLE, KNOWN INHERENT RISK OF DEVICE WAS THE CONCLUSION CODE ASSIGNED TO THIS INVESTIGATION.
ALAMRI N A, EID K, ALSHEHRI M (DECEMBER 05, 2023) DEVELOPMENT OF A PROSTATIC URETHRAL CYST AFTER REZUM CAUSING PERSISTENT LOWER URINARY TRACT SYMPTOMS. CUREUS 15(12): E49969. DOI 10.7759/CUREUS.49969.
IT WAS REPORTED THAT A LITERATURE ARTICLE PUBLISHED IN CUREUS, THAT A CASE STUDY WAS CONDUCTED IN THE CASE OF A 71-YEAR-OLD MALE PATIENT WHO WAS TREATED WITH A WATER VAPOR THERAPY PROCEDURE. THE PATIENT PRESENTED WITH A HISTORY OF DIABETES, HYPERLIPIDEMIA, AND PROSTATIC ENLARGEMENT AND WAS ON ALFUZOSIN. ADDITIONALLY, THE PATIENT COMPLAINED OF URGENCY AND FREQUENCY, WHICH DID NOT IMPROVE AFTER USING SOLIFENACIN. THE PATIENT WAS TREATED WITH WATER VAPOR THERAPY AND BY THE POST-OPERATIVE FOLLOW-UP, THE SYMPTOMS IMPROVED. HOWEVER, FIVE MONTHS AFTER THE TREATMENT, THE PATIENT PRESENTED WITH DYSURIA AND URGENCY. THEREFORE, AN ULTRASOUND WAS PERFORMED TO EVALUATE THE PERSISTENT LOWER URINARY TRACT SYMPTOMS, AND DUE TO THAT, IT WAS IDENTIFIED THAT THE PATIENT DEVELOPED A PROSTATIC URETHRAL CYST. THE DISCOVERED LESION WAS TREATED WITH A CONSERVATIVE TREATMENT APPROACH DUE TO THE DECISION OF THE PATIENT.
IT WAS REPORTED THAT A LITERATURE ARTICLE PUBLISHED IN CUREUS, THAT A CASE STUDY WAS CONDUCTED IN THE CASE OF A 71-YEAR-OLD MALE PATIENT WHO WAS TREATED WITH A WATER VAPOR THERAPY PROCEDURE. THE PATIENT PRESENTED WITH A HISTORY OF DIABETES, HYPERLIPIDEMIA, AND PROSTATIC ENLARGEMENT AND WAS ON ALFUZOSIN. ADDITIONALLY, THE PATIENT COMPLAINED OF URGENCY AND FREQUENCY, WHICH DID NOT IMPROVE AFTER USING SOLIFENACIN. THE PATIENT WAS TREATED WITH WATER VAPOR THERAPY AND BY THE POST-OPERATIVE FOLLOW-UP, THE SYMPTOMS IMPROVED. HOWEVER, FIVE MONTHS AFTER THE TREATMENT, THE PATIENT PRESENTED WITH DYSURIA AND URGENCY. THEREFORE, AN ULTRASOUND WAS PERFORMED TO EVALUATE THE PERSISTENT LOWER URINARY TRACT SYMPTOMS, AND DUE TO THAT, IT WAS IDENTIFIED THAT THE PATIENT DEVELOPED A PROSTATIC URETHRAL CYST. THE DISCOVERED LESION WAS TREATED WITH A CONSERVATIVE TREATMENT APPROACH DUE TO THE DECISION OF THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2315529 | REZUM | UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) | KNS | BOSTON SCIENTIFIC CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Male | Other |