BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCUFLEX URETERAL STENT

    MDR report key: 25088217 · Received May 5, 2026

    Report

    Report Number
    2124215-2026-24343
    Event Type
    Injury
    Date Received
    May 5, 2026
    Date of Event
    February 18, 2025
    Report Date
    May 5, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: DATE OF EVENT: APPROXIMATED TO FEBRUARY 18, 2025, AS TO WHEN THE LITERATURE REPORT WAS PUBLISHED. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. 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. BLOCK G2: LITERATURE SOURCE: DR RAFFAELE BAIO, DEPARTMENT OF UROLOGY, UMBERTO I HOSPITAL OF NOCERA INFERIORE, NOCERA INFERIORE, I 84014 SALERNO, ITALY. EMAIL: [email protected]. BLOCK H6: MDRF PATIENT CODE E0306 CAPTURES THE REPORTABLE EVENT OF SEPSIS. IMDRF PATIENT CODE E1310 CAPTURES THE REPORTABLE EVENT OF URINARY TRACT INFECTION. IMDRF PATIENT CODE E2303 CAPTURES THE REPORTABLE EVENT OF PAIN. IMDRF PATIENT CODE E1302 CAPTURES THE REPORTABLE EVENT OF HEMATURIA. IMDRF PATIENT CODE E232402 CAPTURES THE REPORTABLE EVENT OF URINARY INCONTINENCE. MDRF PATIENT CODE E0506 CAPTURES THE REPORTABLE EVENT OF HEMORRHAGE MDRF PATIENT CODE E1304 CAPTURES THE REPORTABLE EVENT OF URINARY URGENCY. MDRF PATIENT CODE E2114 CAPTURES THE REPORTABLE EVENT OF PERFORATION. MDRF IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF HOSPITALIZATION OR PROLONGED HOSPITALIZATION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN BIOMEDICAL REPORTS THAT A SINGLE CENTER RETROSPECTIVE STUDY EVALUATED THE ETERNAL DILEMMA BETWEEN PERCUTANEOUS NEPHROSTOMY (PCN) AND DOUBLE J STENTING (DJS) IN THE MANAGEMENT OF PATIENTS WITH URETERAL OBSTRUCTION. A TOTAL OF 317 CONSECUTIVE PATIENTS, BOTH MALE AND FEMALE, BETWEEN THE YEAR OF 2019 AND 2023, WERE PRESENTED TO THE EMERGENCY ROOM WITH URETERAL OBSTRUCTION DUE TO BENIGN OR MALIGNANT ETIOLOGIES AND WERE RESOLVED SURGICALLY BY DJS OR NEPHROSTOMY TUBE, WERE INCLUDED IN THE STUDY. SPECIFICALLY, 155 PATIENTS UNDERWENT PCN AND 217 UNDERWENT DJS PLACEMENT. STATISTICAL ANALYSIS INCLUDED CHI SQUARE TESTING FOR COMPLICATION RATES, REPEATED MEASURES ANOVA FOR LABORATORY TRENDS OVER TIME, BONFERRONI CORRECTED MULTIPLE COMPARISONS, MANCOVA WITH AGE AS A COVARIATE, AND INDEPENDENT SAMPLE T-TESTS FOR HOSPITALIZATION DURATION. RESULTS DEMONSTRATED THAT PCN WAS SUPERIOR TO DJS IN TERMS OF RENAL FUNCTION PRESERVATION AND PATIENT PERCEIVED QUALITY OF LIFE. HOWEVER, PCN WAS ASSOCIATED WITH A HIGHER RATE OF POST-OPERATIVE COMPLICATIONS COMPARED WITH DJS. OVERALL, THE STUDY CONCLUDED THAT BOTH PCN AND DJS ARE VIABLE OPTIONS FOR URETERAL OBSTRUCTION IN URGENT SETTINGS, WITH PCN OFFERING IMPROVED RENAL OUTCOMES AND QUALITY OF LIFE (QOL) AT THE EXPENSE OF INCREASED COMPLICATION RATES. THESE FINDINGS COULD HELP THE SURGEON CHOOSE THE RIGHT KIND OF INTERVENTION FOR EACH PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584623 PERCUFLEX URETERAL STENT CATHETER, BILIARY, DIAGNOSTIC FAD BOSTON SCIENTIFIC CORPORATION UNK-P-PERCUFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1