BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPYSCOPE DS II

    MDR report key: 21839853 · Received April 15, 2025

    Report

    Report Number
    3005099803-2025-01652
    Event Type
    Death
    Date Received
    April 15, 2025
    Date of Event
    March 25, 2025
    Report Date
    April 15, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FBN
    PMA / PMN Number
    K183636
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF PATIENT CODE E0602 CAPTURES THE REPORTABLE EVENT OF CARDIAC ARREST. IMDRF IMPACT CODE F2306 CAPTURES THE REPORTABLE EVENT OF CARDIOPULMONARY RESUSCITATION. IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF PATIENT'S DEATH.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SPYSCOPE DS II ACCESS AND DELIVERY CATHETER WAS USED IN THE DUODENUM FOR THE TREATMENT OF STONES ON (B)(6) 2025. DURING THE SPYGLASS PROCEDURE, WHILE PERFORMING IRRIGATION THE ANESTHETIST WARNED OF A RAPID DETERIORATION IN THE PATIENTS VITALS. THE DEVICE WAS SAFELY REMOVED, AND DOCTORS ATTEMPTED CPR. HOWEVER, THE PATIENT PASSED AWAY SHORTLY AFTER. AIR WAS USED FOR INSUFFLATION DURING THE PROCEDURE. IN THE PHYSICIANS ASSESSMENT THE DEVICE DID NOT CONTRIBUTE TO THE PATIENTS COMPLICATIONS. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113022 SPYSCOPE DS II CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN BOSTON SCIENTIFIC CORPORATION M00546610 0034525841

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| D| H| R