BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REZUM

    MDR report key: 15117676 · Received July 27, 2022

    Report

    Report Number
    2124215-2022-27738
    Event Type
    Injury
    Date Received
    July 27, 2022
    Date of Event
    January 1, 2022
    Report Date
    September 2, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURER NARRATIVE: DATE OF EVENT WAS NOT PROVIDED, ESTIMATED DATE ENTERED. FAWAZ ALKERAITHE, SAEED BIN HAMRI, FAISAL ALSALEH, FAISAL ALASMARI. "UNEXPECTED ENCAPSULATED HEMATOMA AFTER RZUM THERAPY: FIRST OUTCOME OF AN EMERGING THERAPY." UROLOGY CASE REPORTS 44 (2022) 102125: HTTPS://DOI.ORG/10.1016/J.EUCR.2022.102125.

    Additional Manufacturer Narrative · 0

    THERE WAS NO DEVICE AVAILABLE FOR ANALYSIS AND THERE WAS NO REPORT OF A DEVICE PERFORMANCE ALLEGATION DURING TREATMENT. THE REPORTED PATIENT SYMPTOMS ARE KNOWN RISK ASSOCIATED WITH IMPLANTS OF THESE DEVICE AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. BASED ON THE INFORMATION AVAILABLE, A CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE WAS ASSIGNED TO THIS INVESTIGATION. CORRECTION PROVIDED IN H6: IMPACT CODES. ADDITIONAL MANUFACTURER NARRATIVE: B3 - DATE OF EVENT WAS NOT PROVIDED, ESTIMATED DATE ENTERED. FAWAZ ALKERAITHE, SAEED BIN HAMRI, FAISAL ALSALEH, FAISAL ALASMARI. "UNEXPECTED ENCAPSULATED HEMATOMA AFTER RZUM THERAPY: FIRST OUTCOME OF AN EMERGING THERAPY." UROLOGY CASE REPORTS 44 (2022) 102125: HTTPS://DOI.ORG/10.1016/J.EUCR.2022.102125.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN UROLOGY CASE REPORTS THE RESULTS OF THE FOLLOWING STUDY. THE ARTICLE DETAILED THE CASE OF A 61 YEAR OLD MALE WITH A PAST MEDICAL HISTORY OF DIABETES WHO UNDERWENT REZUM WATER VAPOR THERAPY PROCEDURE FOR TREATMENT OF LOWER URINARY TRACT SYMPTOMS (LUTS). PRIOR TO THE PROCEDURE THE PATIENT HAD BEEN TAKING ALFUZOCIN TO TREAT HIS LUTS. UROFLOWMETERY STUDY WAS 11 ML/S AND HIS PROSTATE SIZE WAS 88G. THE PATIENT UNDERWENT THE WATER VAPOR THERAPY PROCEDURE WHICH WAS COMPLETED WITHOUT ANY COMPLICATIONS. THE PATIENT WAS DISCHARGED WITH QUINOLONE FOR FIVE DAYS. TWO MONTHS AFTER THE PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF HEMATURIA ASSOCIATED WITH CLOTS, DYSURIA, AND ACUTE URINARY RETENTION. THE PATIENT STATED HE HAD NOT HAD A FEVER. PHYSICAL EXAMINATION OF THE PATIENT AT THE EMERGENCY DEPARTMENT REVEALED SUPRAPUBIC TENDERNESS AND DULLNESS WHICH WAS IMMEDIATELY TREATED BY BLADDER DECOMPRESSION. LAB WORKUP REVEALED A HIGH WHITE BLOOD CELL COUNT. AS A RESULT OF THE FINDINGS, AN ULTRASOUND WAS PERFORMED. THE ULTRASOUND SHOWED AN UNEXPECTEDLY LARGE PROSTATE SIZE MEASURING AT 315 G WITH CYSTIC CHANGES. THE PATIENT WAS GIVEN INTRAVENOUS FLUID AND ANTIBIOTICS FOR INITIAL TREATMENT. A CYSTOSCOPY WAS THEN DONE WITH THE PATIENT UNDER GENERAL ANESTHESIA IN ORDER TO DETERMINE WHAT WAS HAPPENING WITH THE PATIENT. INTRA-OPERATIVELY, THE PHYSICIAN OBSERVED A LARGE ENCAPSULATED SWELLING BELOW THE BLADDER NECK. AFTER INITIAL RESECTION, THE HEMATOMA WAS RECOGNIZED AND EVACUATED COMPLETELY. THEN THE TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE WAS COMPLETED. THE PATIENT WAS DISCHARGED THE NEXT DAY WITH NO ADDITIONAL PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN UROLOGY CASE REPORTS THE RESULTS OF THE FOLLOWING STUDY. THE ARTICLE DETAILED THE CASE OF A 61 YEAR OLD MALE WITH A PAST MEDICAL HISTORY OF DIABETES WHO UNDERWENT REZUM WATER VAPOR THERAPY PROCEDURE FOR TREATMENT OF LOWER URINARY TRACT SYMPTOMS (LUTS). PRIOR TO THE PROCEDURE THE PATIENT HAD BEEN TAKING ALFUZOCIN TO TREAT HIS LUTS. UROFLOWMETERY STUDY WAS 11 ML/S AND HIS PROSTATE SIZE WAS 88G. THE PATIENT UNDERWENT THE WATER VAPOR THERAPY PROCEDURE WHICH WAS COMPLETED WITHOUT ANY COMPLICATIONS. THE PATIENT WAS DISCHARGED WITH QUINOLONE FOR FIVE DAYS. TWO MONTHS AFTER THE PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF HEMATURIA ASSOCIATED WITH CLOTS, DYSURIA, AND ACUTE URINARY RETENTION. THE PATIENT STATED HE HAD NOT HAD A FEVER. PHYSICAL EXAMINATION OF THE PATIENT AT THE EMERGENCY DEPARTMENT REVEALED SUPRAPUBIC TENDERNESS AND DULLNESS WHICH WAS IMMEDIATELY TREATED BY BLADDER DECOMPRESSION. LAB WORKUP REVEALED A HIGH WHITE BLOOD CELL COUNT. AS A RESULT OF THE FINDINGS, AN ULTRASOUND WAS PERFORMED. THE ULTRASOUND SHOWED AN UNEXPECTEDLY LARGE PROSTATE SIZE MEASURING AT 315 G WITH CYSTIC CHANGES. THE PATIENT WAS GIVEN INTRAVENOUS FLUID AND ANTIBIOTICS FOR INITIAL TREATMENT. A CYSTOSCOPY WAS THEN DONE WITH THE PATIENT UNDER GENERAL ANESTHESIA IN ORDER TO DETERMINE WHAT WAS HAPPENING WITH THE PATIENT. INTRA-OPERATIVELY, THE PHYSICIAN OBSERVED A LARGE ENCAPSULATED SWELLING BELOW THE BLADDER NECK. AFTER INITIAL RESECTION, THE HEMATOMA WAS RECOGNIZED AND EVACUATED COMPLETELY. THEN THE TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE WAS COMPLETED. THE PATIENT WAS DISCHARGED THE NEXT DAY WITH NO ADDITIONAL PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2321615 REZUM UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention| H