BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPYSCOPE DS II ACCESS & DELIVERY CATHETER

    MDR report key: 25185161 · Received May 15, 2026

    Report

    Report Number
    3005099803-2026-01914
    Event Type
    Injury
    Date Received
    May 15, 2026
    Date of Event
    November 3, 2025
    Report Date
    May 15, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FBN
    PMA / PMN Number
    K183636
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF CODE E1108 CAPTURES THE REPORTABLE EVENT OF BILOMA. BLOCK B3: DATE OF EVENT IS BASED ON THE ARTICLE PUBLICATION DATE. BLOCK D4, H4: DETAILED MODEL NUMBER AND LOT NUMBER WERE NOT PROVIDED TO BSC. GOOD FAITH EFFORTS WERE COMPLETED TO OBTAIN THIS INFORMATION; HOWEVER FURTHER INFORMATION HAS NOT BEEN RECEIVED TO DATE. BECAUSE THE PRODUCT INFORMATION IS CURRENTLY UNKNOWN, NO UDI AND OTHER PRODUCT SPECIFIC INFORMATION IS AVAILABLE. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK G2: LITERATURE SOURCE: THIAGO FRANCHI NUNES, ET AL. (2025) FLEXIBLE PERCUTANEOUS LASER LITHOTRIPSY FOR INTRAHEPATIC STONES: A MULTICENTER STUDY IN WESTERN PATIENTS CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGICAL SOCIETY OF EUROPE (APRIL 2025):575 TO 584 HTTPS://DOI.ORG/10.1007/S00270 025-04248-8. BLOCK H11: INVESTIGATION RESULTS SUMMARY. THE SPYSCOPE DS II INVOLVED WAS NOT RETURNED FOR ANALYSIS. THE IMAGES FROM THE LITERATURE RECORD DEPICT INTRAOPERATIVE IMAGES PROVIDED BY THE DEVICE WHEN INSERTED INTO THE PATIENT ANATOMY, IN ADDITION TO FLUOROSCOPIC IMAGES. HOWEVER, THERE ARE NO SPYGLASS DS II DAMAGES OR ISSUES SHOWN IN THE IMAGES FROM THE ARTICLE THAT MAY SUGGEST A DEVICE MALPERFORMANCE. THE REPORTED EVENT OF DEVICE, NO KNOWN DEVICE PROBLEM IS CONFIRMED. REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THERE WAS RELEVANT CONTENT AND SUFFICIENT GUIDANCE WITH RESPECT TO THE CIRCUMSTANCES DESCRIBED WITHIN THIS COMPLAINT. NO UPDATES ARE REQUIRED TO THE IFU AS A RESULT OF THIS EVENT. IT WAS CONFIRMED THAT THE IFU LISTS MUCOUS MEMBRANE DAMAGE & TISSUE DAMAGE AS AN ADVERSE EVENT RESULTING FROM THE USE OF THE DEVICE, WHICH COULD POTENTIALLY RESULT IN THE REPORTED BILOMA. THERE IS NO EVIDENCE THAT THE DEVICE WAS IMPROPERLY USED PER THE IFU. BASED ON THE EVENT DESCRIPTION AND INFORMATION PROVIDED BY THE AUTHOR, THERE IS INSUFFICIENT EVIDENCE TO SUGGEST THAT A SPYSCOPE DS II MALFUNCTION CONTRIBUTED TO THE REPORTED EVENT OF BILOMA, WHICH NECESSITATED ADDITIONAL DRAINAGE AND ANTIBIOTIC THERAPY. BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF ADVERSE EVENT RELATED TO PROCEDURE.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING SPYSCOPE DS THROUGH AN ARTICLE TITLED: FLEXIBLE PERCUTANEOUS LASER LITHOTRIPSY FOR INTRAHEPATIC STONES: A MULTICENTER STUDY IN WESTERN PATIENTS BY THIAGO FRANCHI NUNES, ET AL. PER THE ARTICLE, BETWEEN JAN 2022 TO FEB 2025, 35 PATIENTS UNDERWENT CHOLANGIOSCOPY-GUIDED LITHOTRIPSY PROCEDURES UTILIZING THE SPYSCOPE DS FOR VARIOUS INDICATIONS. ONE CASE OF LOCALIZED BILOMA REQUIRING DRAINAGE AND ANTIBIOTIC THERAPY WAS REPORTED. PLEASE SEE REFERENCE ARTICLE FOR FULL DETAILS. THIAGO FRANCHI NUNES, ET AL. (2025) FLEXIBLE PERCUTANEOUS LASER LITHOTRIPSY FOR INTRAHEPATIC STONES: A MULTICENTER STUDY IN WESTERN PATIENTS CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGICAL SOCIETY OF EUROPE (APRIL 2025):575 TO 584 HTTPS://DOI.ORG/10.1007/S00270 025-04248-8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284067 SPYSCOPE DS II ACCESS & DELIVERY CATHETER CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention