BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 16816777 · Received April 26, 2023

    Report

    Report Number
    2124215-2023-19529
    Event Type
    Injury
    Date Received
    April 26, 2023
    Date of Event
    December 1, 2013
    Report Date
    May 18, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION PROVIDED IN B5: DESCRIPTION OF EVENT - AT ONE POINT 102W WAS WRITTEN INSTEAD OF 120W 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. SUN J, SHI A, TONG Z, CHI C. GREEN LIGHT PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE: A SAFE AND EFFECTIVE TREATMENT FOR ELDERLY HIGH-RISK BENIGN PROSTATE HYPERPLASIA PATIENTS WITH GLAND OVER 80 ML. LASERS MED SCI. 2018;33:1693-8. THIS REPORT IS FOR THE SAME ARTICLE AS REPORTED UNDER MANUFACTURER NUMBER 2124215-2023-19544.

    Additional Manufacturer Narrative · 0

    SUN J, SHI A, TONG Z, CHI C. GREEN LIGHT PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE: A SAFE AND EFFECTIVE TREATMENT FOR ELDERLY HIGH-RISK BENIGN PROSTATE HYPERPLASIA PATIENTS WITH GLAND OVER 80 ML. LASERS MED SCI. 2018;33:1693-8. THIS REPORT IS FOR THE SAME ARTICLE AS REPORTED UNDER MANUFACTURER NUMBER 2124215-2023-19544.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN LASERS IN MEDICAL SCIENCE THAT A STUDY WAS CONDUCTED TO COMPARE AND ANALYZE THE EFFICACY AND SAFETY OF GREENLIGHT PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE (PVP) PROCEDURES IN ELDERLY HIGH-RISK BENIGN PROSTATE HYPERPLASIA (BPH) PATIENTS. THE STUDY COMPARED THE RESULTS OF PATIENTS WHO UNDERWENT 120 W GREENLIGHT HPS PROCEDURES TO THOSE WHO UNDERWENT 180 W GREENLIGHT XPS PROCEDURES. A TOTAL OF 84 PATIENTS UNDERWENT THE PVP PROCEDURE BETWEEN DECEMBER 2013 AND FEBRUARY 2016. OF THESE PATIENTS, 40 PATIENTS UNDERWENT THE 120 W PROCEDURE AND 44 UNDERWENT THE 180 W PROCEDURE. ALL PATIENTS HAD A PROSTATE GLAND VOLUME OVER 80 ML AND HAD AT LEAST ONE INTRAOPERATIVE COMORBIDITY: HYPERTENSION, DIABETES MELLITUS, NEW YORK HEART ASSOCIATION (NYHA) II, OR COMBINED. ALL PROCEDURES WERE CONDUCTED WITH THE PATIENTS UNDER GENERAL ANESTHESIA. A STORZ 22F CONTINUOUS FLOW CYSTOSCOPE WITH A LASER BRIDGE WAS USED, THE FIBER WAS INSERTED THROUGH THE CONTINUOUS FLOW CYSTOSCOPE WITH A SEPARATE CHANNEL, AND STERILE WATER WAS USED AS AN IRRIGATION FLUID. ALL PROCEDURES WERE COMPLETED SUCCESSFULLY WITHOUT PATIENT COMPLICATIONS. FOLLOW-UP VISITS WERE THEN CONDUCTED AT 4 WEEKS, 6 MONTHS, AND 1 YEAR POST-PROCEDURE. PATIENTS IN THE 120 W GROUP EXPERIENCED THE FOLLOWING COMPLICATIONS: 3 PATIENTS HAD FEVER, 2 PATIENTS EXPERIENCED BLEEDING, 7 PATIENTS EXPERIENCED URGE INCONTINENCE, 1 PATIENT EXPERIENCED URETHROSTENOSIS, 1 PATIENT EXPERIENCED BLADDER NECK CONTRACTURE, AND 1 PATIENT REQUIRED RE-CATHETERIZATION. PATIENTS IN THE 180 W GROUP EXPERIENCED THE FOLLOWING COMPLICATIONS: 2 PATIENTS HAD FEVER, 2 PATIENTS EXPERIENCED BLEEDING, 10 PATIENTS EXPERIENCED URGE INCONTINENCE, 2 PATIENTS EXPERIENCED BLADDER NECK CONTRACTURE, AND 2 PATIENTS REQUIRED RE-CATHETERIZATION. MOST OF THE PATIENTS WHO EXPERIENCED URGE INCONTINENCE FROM BOTH GROUPS SHOWED RECOVERY WITHIN 6 MONTHS POST-PROCEDURE. ONLY ONE OF THE PATIENTS FROM THE 180 W GROUP REPORTED EXPERIENCING URGE INCONTINENCE UP UNTIL THE 1 YEAR VISIT POST-PROCEDURE. OVERALL, IT WAS NOTED THAT THE OPERATION TIME AND CATHETERIZATION TIME WAS SIGNIFICANTLY SHORTER FOR PATIENTS WHO UNDERWENT THE 180 W PROCEDURE COMPARED TO THOSE WHO UNDERWENT THE 120 W PROCEDURE. PATIENTS FROM BOTH GROUPS HAVE SHOW SIGNIFICANT IMPROVEMENTS IN THE INTERNATIONAL PROSTATE SYMPTOM SCORES (IPSS), QUALITY OF LIFE (QOL) SCORES, MAXIMUM FLOW RATE (QMAX), AND RESIDUAL URINE VOLUME (RUV). THIS REPORT IS FOR THE PATIENTS WHO UNDERWENT THE 120W PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN LASERS IN MEDICAL SCIENCE THAT A STUDY WAS CONDUCTED TO COMPARE AND ANALYZE THE EFFICACY AND SAFETY OF GREENLIGHT PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE (PVP) PROCEDURES IN ELDERLY HIGH-RISK BENIGN PROSTATE HYPERPLASIA (BPH) PATIENTS. THE STUDY COMPARED THE RESULTS OF PATIENTS WHO UNDERWENT 120 W GREENLIGHT HPS PROCEDURES TO THOSE WHO UNDERWENT 180 W GREENLIGHT XPS PROCEDURES. A TOTAL OF 84 PATIENTS UNDERWENT THE PVP PROCEDURE BETWEEN DECEMBER 2013 AND FEBRUARY 2016. OF THESE PATIENTS, 40 PATIENTS UNDERWENT THE 102 W PROCEDURE AND 44 UNDERWENT THE 180 W PROCEDURE. ALL PATIENTS HAD A PROSTATE GLAND VOLUME OVER 80 ML AND HAD AT LEAST ONE INTRAOPERATIVE COMORBIDITY: HYPERTENSION, DIABETES MELLITUS, NEW YORK HEART ASSOCIATION (NYHA) II, OR COMBINED. ALL PROCEDURES WERE CONDUCTED WITH THE PATIENTS UNDER GENERAL ANESTHESIA. A STORZ 22F CONTINUOUS FLOW CYSTOSCOPE WITH A LASER BRIDGE WAS USED, THE FIBER WAS INSERTED THROUGH THE CONTINUOUS FLOW CYSTOSCOPE WITH A SEPARATE CHANNEL, AND STERILE WATER WAS USED AS AN IRRIGATION FLUID. ALL PROCEDURES WERE COMPLETED SUCCESSFULLY WITHOUT PATIENT COMPLICATIONS. FOLLOW-UP VISITS WERE THEN CONDUCTED AT 4 WEEKS, 6 MONTHS, AND 1 YEAR POST-PROCEDURE. PATIENTS IN THE 120 W GROUP EXPERIENCED THE FOLLOWING COMPLICATIONS: 3 PATIENTS HAD FEVER, 2 PATIENTS EXPERIENCED BLEEDING, 7 PATIENTS EXPERIENCED URGE INCONTINENCE, 1 PATIENT EXPERIENCED URETHROSTENOSIS, 1 PATIENT EXPERIENCED BLADDER NECK CONTRACTURE, AND 1 PATIENT REQUIRED RE-CATHETERIZATION. PATIENTS IN THE 180 W GROUP EXPERIENCED THE FOLLOWING COMPLICATIONS: 2 PATIENTS HAD FEVER, 2 PATIENTS EXPERIENCED BLEEDING, 10 PATIENTS EXPERIENCED URGE INCONTINENCE, 2 PATIENTS EXPERIENCED BLADDER NECK CONTRACTURE, AND 2 PATIENTS REQUIRED RE-CATHETERIZATION. MOST OF THE PATIENTS WHO EXPERIENCED URGE INCONTINENCE FROM BOTH GROUPS SHOWED RECOVERY WITHIN 6 MONTHS POST-PROCEDURE. ONLY ONE OF THE PATIENTS FROM THE 180 W GROUP REPORTED EXPERIENCING URGE INCONTINENCE UP UNTIL THE 1 YEAR VISIT POST-PROCEDURE. OVERALL, IT WAS NOTED THAT THE OPERATION TIME AND CATHETERIZATION TIME WAS SIGNIFICANTLY SHORTER FOR PATIENTS WHO UNDERWENT THE 180 W PROCEDURE COMPARED TO THOSE WHO UNDERWENT THE 120 W PROCEDURE. PATIENTS FROM BOTH GROUPS HAVE SHOW SIGNIFICANT IMPROVEMENTS IN THE INTERNATIONAL PROSTATE SYMPTOM SCORES (IPSS), QUALITY OF LIFE (QOL) SCORES, MAXIMUM FLOW RATE (QMAX), AND RESIDUAL URINE VOLUME (RUV). THIS REPORT IS FOR THE PATIENTS WHO UNDERWENT THE 120W PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488579 UNKNOWN POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC CORPORATION UNK-P-GREENLIGHT FIBER

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R