BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOXY

    MDR report key: 22386736 · Received July 2, 2025

    Report

    Report Number
    2124215-2025-43852
    Event Type
    Injury
    Date Received
    July 2, 2025
    Date of Event
    July 15, 2024
    Report Date
    July 29, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEX
    UDI-DI
    00878953005515
    PMA / PMN Number
    K120870
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BASED ON THE NATURE OF THE INFORMATION PROVIDED TO BSC, IT IS NOT POSSIBLE TO PERFORM A GOOD FAITH EFFORT TO OBTAIN ADDITIONAL INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION TO H11 STATEMENT TO REFLECT THE FOLLOWING: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TO BOSTON SCIENTIFIC VIA TRANSLATIONAL ANDROLOGY AND UROLOGY, THAT A RETROSPECTIVE STUDY WAS CONDUCTED AT SHANDONG PROVINCIAL HOSPITAL AFFILIATED TO SHANDONG FIRST MEDICAL UNIVERSITY, CHINA, TO EVALUATE THE EFFICACY AND SAFETY OF TRANSURETHRAL BLADDER MUCOSAL GREENLIGHT LASER-SELECTIVE VAPORIZATION FOR WOMEN WITH REFRACTORY OVERACTIVE BLADDER (OAB) WHO HAD NOT RESPONDED TO CONVENTIONAL TREATMENTS. 32 FEMALE PATIENTS WITH A MEAN AGE OF 57.9 YEARS WERE INCLUDED AND UNDERWENT THE PROCEDURE BETWEEN MAY 2022 AND JULY 2023. ALL PROCEDURES WERE PERFORMED SUCCESSFULLY UNDER GENERAL ANESTHESIA BY AN EXPERIENCED UROLOGIST USING THE GREENLIGHT XPS LASER SYSTEM (REALTON CORPORATION, BEIJING, CHINA) WITH SIDE-FIRING FLARE LASER FIBERS, APPLYING 30 W FOR COAGULATION AND 80 W FOR VAPORIZATION; ISOTONIC SALINE WAS USED AS THE FLUSHING AGENT, AND VAPORIZATION WAS CONDUCTED BY DIRECTING THE FIBER TIP TO THE LESION SITES AT A DISTANCE OF TWO FIBER CAPS (3.6 MM) FROM THE MUCOSA. THE MEAN OPERATIVE TIME WAS 57.4 MINUTES, MEAN BLOOD LOSS WAS 6.9 ML, MEAN CATHETERIZATION WAS 2.9 DAYS, AND MEAN HOSPITAL STAY WAS 3.9 DAYS. TWELVE WEEKS POSTOPERATIVELY, SIGNIFICANT IMPROVEMENTS WERE OBSERVED IN OVERACTIVE BLADDER SYMPTOM SCORE (OABSS), THREE-DAY BLADDER DIARY METRICS (DAYTIME FREQUENCY, NOCTURIA, URGENCY, URGENCY INCONTINENCE), OVERACTIVE BLADDER QUESTIONNAIRE SHORT FORM (OAB-QSF) SCORE, FIRST DESIRE TO VOID (FDV), AND MAXIMUM BLADDER CAPACITY (MCBC). COMPLICATIONS WERE RARE AND MILD: ONLY 3 PATIENTS (9.4%) DEVELOPED URINARY TRACT INFECTIONS POSTOPERATIVELY, ALL OF WHICH RESOLVED WITH ANTIBIOTIC TREATMENT; NO SEVERE COMPLICATIONS SUCH AS BLEEDING, URINARY FISTULA, OR BLADDER CONTRACTURE WERE OBSERVED. IN CONCLUSION, THIS STUDY SUGGESTS THAT TRANSURETHRAL BLADDER MUCOSAL GREENLIGHT LASER MAY BE A PROMISING AND SAFE ALTERNATIVE FOR FEMALE PATIENTS WITH REFRACTORY OAB, PROVIDING SIGNIFICANT SYMPTOMATIC IMPROVEMENT AND MINIMAL RISK OF COMPLICATIONS, LIKELY MEDIATED BY SUPPRESSION OF INFLAMMATORY AND SENSORY PATHWAYS IN THE BLADDER MUCOSA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TO BOSTON SCIENTIFIC VIA TRANSLATIONAL ANDROLOGY AND UROLOGY, THAT A RETROSPECTIVE STUDY WAS CONDUCTED AT (B)(6) HOSPITAL AFFILIATED TO (B)(6) CHINA, TO EVALUATE THE EFFICACY AND SAFETY OF TRANSURETHRAL BLADDER MUCOSAL GREENLIGHT LASER-SELECTIVE VAPORIZATION FOR WOMEN WITH REFRACTORY OVERACTIVE BLADDER (OAB) WHO HAD NOT RESPONDED TO CONVENTIONAL TREATMENTS. 32 FEMALE PATIENTS WITH A MEAN AGE OF 57.9 YEARS WERE INCLUDED AND UNDERWENT THE PROCEDURE BETWEEN MAY 2022 AND JULY 2023. ALL PROCEDURES WERE PERFORMED SUCCESSFULLY UNDER GENERAL ANESTHESIA BY AN EXPERIENCED UROLOGIST USING THE GREENLIGHT XPS LASER SYSTEM (REALTON CORPORATION, BEIJING, CHINA) WITH SIDE-FIRING FLARE LASER FIBERS, APPLYING 30 W FOR COAGULATION AND 80 W FOR VAPORIZATION; ISOTONIC SALINE WAS USED AS THE FLUSHING AGENT, AND VAPORIZATION WAS CONDUCTED BY DIRECTING THE FIBER TIP TO THE LESION SITES AT A DISTANCE OF TWO FIBER CAPS (3.6 MM) FROM THE MUCOSA. THE MEAN OPERATIVE TIME WAS 57.4 MINUTES, MEAN BLOOD LOSS WAS 6.9 ML, MEAN CATHETERIZATION WAS 2.9 DAYS, AND MEAN HOSPITAL STAY WAS 3.9 DAYS. TWELVE WEEKS POSTOPERATIVELY, SIGNIFICANT IMPROVEMENTS WERE OBSERVED IN OVERACTIVE BLADDER SYMPTOM SCORE (OABSS), THREE-DAY BLADDER DIARY METRICS (DAYTIME FREQUENCY, NOCTURIA, URGENCY, URGENCY INCONTINENCE), OVERACTIVE BLADDER QUESTIONNAIRE SHORT FORM (OAB-QSF) SCORE, FIRST DESIRE TO VOID (FDV), AND MAXIMUM BLADDER CAPACITY (MCBC). COMPLICATIONS WERE RARE AND MILD: ONLY 3 PATIENTS (9.4%) DEVELOPED URINARY TRACT INFECTIONS POSTOPERATIVELY, ALL OF WHICH RESOLVED WITH ANTIBIOTIC TREATMENT; NO SEVERE COMPLICATIONS SUCH AS BLEEDING, URINARY FISTULA, OR BLADDER CONTRACTURE WERE OBSERVED. IN CONCLUSION, THIS STUDY SUGGESTS THAT TRANSURETHRAL BLADDER MUCOSAL GREENLIGHT LASER MAY BE A PROMISING AND SAFE ALTERNATIVE FOR FEMALE PATIENTS WITH REFRACTORY OAB, PROVIDING SIGNIFICANT SYMPTOMATIC IMPROVEMENT AND MINIMAL RISK OF COMPLICATIONS, LIKELY MEDIATED BY SUPPRESSION OF INFLAMMATORY AND SENSORY PATHWAYS IN THE BLADDER MUCOSA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28027 MOXY POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC CORPORATION 0010-2400 00878953005515

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other