BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCUFLEX URETERAL STENT

    MDR report key: 25108649 · Received May 7, 2026

    Report

    Report Number
    2124215-2026-24712
    Event Type
    Injury
    Date Received
    May 7, 2026
    Date of Event
    June 1, 2020
    Report Date
    May 7, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: THE EXACT EVENT DATE IS UNKNOWN. THE PROVIDED EVENT DATE IS AN APPROXIMATE BASED ON THE RANGE THE PROCEDURES WERE PERFORMED. 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. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(6). BLOCK G2: LITERATURE SOURCE: HAMAMOTO-2025-URETERAL STENT BIOMATERIAL ENCRUSTATION AFTER ENDOSCOPIC LITHOTRIPSY: A RANDOMIZED, SINGLEBLIND STUDY: WWW.NATURE.COM/SCIENTIFICREPORTS/ HTTPS://DOI.ORG/10.1038/S41598-025-95095-7. BLOCK H6: IMDRF DEVICE CODE A040501 CAPTURES THE REPORTABLE EVENT OF STENT CALCIFICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN SCIENTIFIC REPORTS, A JOURNAL BY NATURE, TITLED, URETERAL STENT BIOMATERIAL ENCRUSTATION AFTER ENDOSCOPIC LITHOTRIPSY: A RANDOMIZED, SINGLE BLIND STUDY. THE STUDY EVALUATING BIOMINERAL AND BACTERIAL ADHERENCE TO THREE URETERAL STENT TYPES FOLLOWING ENDOSCOPIC LITHOTRIPSY, INCLUDING THE BOSTON SCIENTIFIC PERCUFLEX (HYDROPLUS COATING) AND TRIA (PERCUSHIELD COATING) STENTS. THIS STUDY WAS CONDUCTED BETWEEN JUNE 2020 TO JANUARY 2021 IN ACCORDANCE WITH TENETS OF THE DECLARATION OF HELSINKI. SIXTY ONE PATIENTS WERE RANDOMIZED, AND STENTS WERE REMOVED AFTER APPROXIMATELY ONE MONTH. THE PUBLICATION REPORTED THAT THE PERCUFLEX STENT DEMONSTRATED SIGNIFICANTLY HIGHER CALCIUM AND MAGNESIUM BIOMINERAL ATTACHMENT COMPARED TO THE TRIA STENT AND A NON BOSTON SCIENTIFIC COMPARATOR, WHILE BACTERIAL ADHESION DID NOT DIFFER SIGNIFICANTLY. SECONDARY OBSERVATIONS INDICATED HIGHER RATES OF STENT DISCOLORATION, STONE ENCRUSTATION, AND WORSE URINARY SYMPTOM SCORES IN THE PERCUFLEX GROUP COMPARED TO TRIA. EXPLORATORY ANALYSES IDENTIFIED STENT TYPE AND PREOPERATIVE URETERAL STENTING AS INDEPENDENT RISK FACTORS FOR CALCIUM ENCRUSTATION. THE STUDY CONCLUDED THAT STENTS WITH PERCUSHIELD COATING, INCLUDING TRIA, SHOWED REDUCED BIOMINERAL ADHERENCE AND IMPROVED URINARY SYMPTOM SCORES RELATIVE TO HYDROPLUS COATED STENTS. THE STUDY'S LIMITATIONS INCLUDED SINGLE CENTER DESIGN, SHORT INDWELLING DURATION, AND LIMITED STONE TYPE DIVERSITY. NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE EVENT INVOLVING THE TRIA URETERAL STENT THAT HAS BEEN INCLUDED IN THE SAME STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494384 PERCUFLEX URETERAL STENT CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC CORPORATION UNK-P-PERCUFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1