BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REZUM

    MDR report key: 17670074 · Received September 1, 2023

    Report

    Report Number
    2124215-2023-47409
    Event Type
    Injury
    Date Received
    September 1, 2023
    Date of Event
    August 18, 2023
    Report Date
    October 27, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 IMPLANT 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.

    Additional Manufacturer Narrative · 0

    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 IMPLANT 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS ENROLLED IN THE REZUM VAPEUR RCT STUDY ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT'S URINARY TRACT INFECTION (UTI) STATUS WAS NEGATIVE, AND HEMATURIA WAS NOT PRESENT. THE PATIENT UNDERWENT A WATER VAPOR THERAPY PROCEDURE ON (B)(6) 2023 UNDER ANESTHESIA. THE PATIENT WAS ALSO PRESCRIBED PROPHYLACTIC ANTIBIOTICS. THE PATIENT RECEIVED THREE TREATMENTS IN THE RIGHT LOBE AND THREE TREATMENTS IN THE LEFT LOBE. NO TREATMENTS WERE PERFORMED IN THE MEDIAN LOBE. DURING THE PROCEDURE, THERE WERE NO ADVERSE EVENTS OR DEVICE MALFUNCTIONS. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THE PATIENT WAS DISCHARGED WITH AN INDWELLING CATHETER WHICH WAS REMOVED BY A NURSE AT THE PATIENT'S HOME ON (B)(6) 2023. ON (B)(6) 2023, 10 DAYS AFTER THE PROCEDURE, THE PATIENT PRESENTED WITH A NON-SERIOUS URINARY TRACT INFECTION. THE PATIENT WAS TREATED WITH LEVOFLOXACINE AND THE EVENT WAS CONSIDERED RESOLVED ON (B)(6) 2023. ON (B)(6) 2023, 39 DAYS AFTER THE PROCEDURE, THE PATIENT PRESENTED WITH SERIOUS ACUTE BACTERIAL PROSTATITIS. THE PATIENT WAS HOSPITALIZED (B)(6) 2023. HE WAS TREATED WITH PHLOROGLUCINOL, CEFTRIAXONE, AND CIPROFLOXACINE. THE CIPROFLOXACINE MEDICATION WAS ONGOING. THE PHYSICIAN BELIEVES BOTH THE URINARY TRACT INFECTION AND BACTERIAL PROSTATITIS MAY BE RELATED TO THE WATER VAPOR THERAPY PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS ENROLLED IN THE REZUM VAPEUR RCT STUDY ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT'S URINARY TRACT INFECTION (UTI) STATUS WAS NEGATIVE, AND HEMATURIA WAS NOT PRESENT. THE PATIENT UNDERWENT A WATER VAPOR THERAPY PROCEDURE ON (B)(6) 2023 UNDER ANESTHESIA. THE PATIENT WAS ALSO PRESCRIBED PROPHYLACTIC ANTIBIOTICS. THE PATIENT RECEIVED THREE TREATMENTS IN THE RIGHT LOBE AND THREE TREATMENTS IN THE LEFT LOBE. NO TREATMENTS WERE PERFORMED IN THE MEDIAN LOBE. DURING THE PROCEDURE, THERE WERE NO ADVERSE EVENTS OR DEVICE MALFUNCTIONS. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THE PATIENT WAS DISCHARGED WITH AN INDWELLING CATHETER WHICH WAS REMOVED BY A NURSE AT THE PATIENT'S HOME ON (B)(6) 2023. ON (B)(6) 2023, 10 DAYS AFTER THE PROCEDURE, THE PATIENT PRESENTED WITH A NON-SERIOUS URINARY TRACT INFECTION. THE PATIENT WAS TREATED WITH LEVOFLOXACINE AND THE EVENT WAS CONSIDERED RESOLVED ON (B)(6) 2023. ON (B)(6) 2023, 39 DAYS AFTER THE PROCEDURE, THE PATIENT PRESENTED WITH SERIOUS ACUTE BACTERIAL PROSTATITIS. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2023 TO (B)(6) 2023. HE WAS TREATED WITH PHLOROGLUCINOL, CEFTRIAXONE, AND CIPROFLOXACINE. THE CIPROFLOXACINE MEDICATION WAS ONGOING. THE ACUTE BACTERIAL PROSTATITIS WAS CONSIDERED RESOLVED ON (B)(6) 2023. THE PHYSICIAN BELIEVES BOTH THE URINARY TRACT INFECTION AND BACTERIAL PROSTATITIS MAY BE RELATED TO THE WATER VAPOR THERAPY PROCEDURE.

    Description of Event or Problem · 0

    PN 09/05 IT WAS REPORTED THAT THE PATIENT WAS ENROLLED IN THE REZUM VAPEUR RCT STUDY ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT'S URINARY TRACT INFECTION (UTI) STATUS WAS NEGATIVE, AND HEMATURIA WAS NOT PRESENT. THE PATIENT UNDERWENT A WATER VAPOR THERAPY PROCEDURE. ON (B)(6) 2023, UNDER ANESTHESIA. THE PATIENT WAS ALSO PRESCRIBED PROPHYLACTIC ANTIBIOTICS. THE PATIENT RECEIVED THREE TREATMENTS IN THE RIGHT LOBE AND THREE TREATMENTS IN THE LEFT LOBE. NO TREATMENTS WERE PERFORMED IN THE MEDIAN LOBE. DURING THE PROCEDURE, THERE WERE NO ADVERSE EVENTS OR DEVICE MALFUNCTIONS. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THE PATIENT WAS DISCHARGED WITH AN INDWELLING CATHETER WHICH WAS REMOVED BY A NURSE AT THE PATIENT'S HOME ON (B)(6) 2023. ON (B)(6) 2023 10 DAYS AFTER THE PROCEDURE, THE PATIENT PRESENTED WITH A NON-SERIOUS URINARY TRACT INFECTION. THE PATIENT WAS TREATED WITH LEVOFLOXACINE AND THE EVENT WAS CONSIDERED RESOLVED ON (B)(6) 2023. ON (B)(6) 2023, 39 DAYS AFTER THE PROCEDURE, THE PATIENT PRESENTED WITH SERIOUS ACUTE BACTERIAL PROSTATITIS. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2023. HE WAS TREATED WITH PHLOROGLUCINOL, CEFTRIAXONE, AND CIPROFLOXACINE. THE CIPROFLOXACINE MEDICATION WAS ONGOING. THE PHYSICIAN BELIEVES BOTH THE URINARY TRACT INFECTION AND BACTERIAL PROSTATITIS MAY BE RELATED TO THE WATER VAPOR THERAPY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1389612 REZUM UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION D2201 0031450606

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention| H