BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYGLASS DISCOVER DIGITAL CATHETER

    MDR report key: 18888500 · Received March 12, 2024

    Report

    Report Number
    3005099803-2024-00837
    Event Type
    Malfunction
    Date Received
    March 12, 2024
    Date of Event
    February 12, 2024
    Report Date
    March 12, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FBN
    UDI-DI
    08714729994183
    PMA / PMN Number
    K200483
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2 (PRO CODE): NTN. BLOCK H6 (IMPACT CODES): IMDRF IMPACT CODE F05 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF DELAY TO TREATMENT/THERAPY.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SPY DISCOVER CATHETER COMPLAINT WAS USED DURING PERCUTANEOUS CHOLANGIOSCOPY FOR THE TREATMENT OF GALLSTONES PERFORMED IN THE GALLBLADDER ON (B)(6) 2024. DURING THE PROCEDURE, WHEN THE SCOPE AND BASKET WERE USED TO REMOVE GALLSTONES FROM THE GALLBLADDER, THE 3 DOTS APPEARED ON THE SCREEN, AND THEY LOST VISUALIZATION FROM THE SCOPE. THE PROCEDURE WAS NOT COMPLETED AND RESCHEDULED ON (B)(6) 2024. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724287 SPYGLASS DISCOVER DIGITAL CATHETER Choledochoscope and accessories, flexible/rigid FBN BOSTON SCIENTIFIC CORPORATION M00546780 0032268294 08714729994183

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown