BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYGLASS DISCOVER DIGITAL CATHETER

    MDR report key: 19253617 · Received May 6, 2024

    Report

    Report Number
    3005099803-2024-02014
    Event Type
    Malfunction
    Date Received
    May 6, 2024
    Date of Event
    April 11, 2024
    Report Date
    May 6, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FBN
    PMA / PMN Number
    K200483
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B (PRO CODE) NTN BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. BLOCK H6 (IMPACT CODES): IMDRF IMPACT CODE F1001 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF ABORTED/CANCELLED PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS DISCOVER DIGITAL CATHETER WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED FOR THE TREATMENT OF CHOLELITHIASIS ON (B)(6) 2024. DURING THE PROCEDURE, THE IMAGE CUT OUT AND WOULDN'T RECONNECT. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THE PATIENT WAS RESCHEDULED FOR THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599432 SPYGLASS DISCOVER DIGITAL CATHETER Choledochoscope and accessories, flexible/rigid FBN BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown