BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REZUM

    MDR report key: 20001363 · Received August 20, 2024

    Report

    Report Number
    2124215-2024-47195
    Event Type
    Injury
    Date Received
    August 20, 2024
    Date of Event
    January 1, 2015
    Report Date
    August 19, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. ACCORDING TO THE REVIEW, URINARY URGENCY IS 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. - KAUFMAN R., ROEHRBORN C., RUKSTALIS D., ELTERMAN D., AND KAPLAN S. BPH-RELATED PROCEDURES OCCURRING IN MEDICAL THERAPY PATIENTS COMPARED TO TRADITIONAL SURGERY AND MIST PATIENTS: A LARGE-SCALE, REAL-WORLD ANALYSIS. CUAJ OCT 2023: 17 (10): S181. B3. DATE OF EVENT THE EXACT DATE OF THE EVENT IS UNKNOWN, ESTIMATED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN CANADIAN UROLOGICAL ASSOCIATION JOURNAL, THAT A STUDY WAS CONDUCTED TO COMPARE THE BENIGN PROSTATE HYPERPLASIA (BPH) RELATED PROCEDURES THAT OCCURRED WITH DISEASE PROGRESSION ON DAILY MEDICATION VERSUS THOSE WITH SURGICAL TREATMENT FOR BPH. THE INVESTIGATION INVOLVED A TOTAL OF 203,504 PATIENTS, DIVIDED IN TWO GROUPS. A GROUP WHO RECEIVED MEDICAL THERAPY ONLY AND A SECOND GROUP WHO WERE ON AN OUTPATIENT SURGERY, SUCH AS TRANSURETHRAL RESECTION OF THE PROSTATE (TURP), PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE (PVP), AQUABLATION, PROSTATIC URETHRAL LIFT (PUL-UROLIFT) AND WATER VAPOR THERAPY WITHIN THE YEARS 2015 TO 2021. DURING THE STUDY, WAS DISCOVERED THAT THERE WERE FOLLOWING SURGICAL TREATMENTS ON PATIENTS EITHER AFTER INITIATION OF MEDICAL THERAPY OR POST PROCEDURES THROUGH 12-MONTHS POST-TREATMENT AND ABOUT A 5.5% OF MEDICAL THERAPY PATIENTS EXPERIENCED A BPH-RELATED PROCEDURE. THE MOST FREQUENT BPH-RELATED PROCEDURES IN BOTH GROUPS WERE CYSTOSCOPY, CATHETERIZATION AND BLADDER IRRIGATION. REGARDING THE SURGICAL PROCEDURE GROUP, THE RATES OF POST-OPERATIVE BPH-RELATED PROCEDURES WERE HIGHEST AFTER WATER VAPOR THERAPY, FOLLOWING ARE THE TRADITIONAL SURGERIES (TURP, PVP, AQUABLATION) AND THE LOWEST RATE WAS FOR PUL-UROLIFT PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1327156 REZUM UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other