BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPYGLASS DISCOVER DIGITAL CATHETER

    MDR report key: 19601754 · Received June 24, 2024

    Report

    Report Number
    3005099803-2024-02951
    Event Type
    Injury
    Date Received
    June 24, 2024
    Date of Event
    May 29, 2024
    Report Date
    September 19, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FBN
    UDI-DI
    08714729994183
    PMA / PMN Number
    K200483
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D4 AND H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK H6: PATIENT CODE A24 CAPTURES THE REPORTABLE EVENT OF BILE DUCT LEAKAGE. BLOCK H11: CORRECTION: BLOCK H6 PATIENT CODE HAS BEEN CORRECTED.

    Additional Manufacturer Narrative · 0

    BLOCK D4 AND H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK H6: PATIENT CODE A24 CAPTURES THE REPORTABLE EVENT OF BILE DUCT LEAKAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS DISCOVER DIGITAL CATHETER ALONG WITH ACCESSORIES WERE USED IN THE LAPAROSCOPIC COMMON BILE DUCT EXPLORATION (LCBDE) DURING A CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2024. WHEN THE PATIENT HAD A CHOLECYSTECTOMY WITH AN INTRAOPERATIVE CHOLANGIOGRAM (IOC) IN THE LAPAROSCOPIC COMMON BILE DUCT EXPLORATION (LCBDE) ON (B)(6) 2024. THE PHYSICIAN REPORTED THE PATIENT PRESENTED WITH BILE DUCT LEAK ON CT SCAN. ON (B)(6) 2024, THE PATIENT WAS SCHEDULED FOR AN ERCP FOLLOW UP FOR A MEDICAL INTERVENTION. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS DISCOVER DIGITAL CATHETER ALONG WITH ACCESSORIES WERE USED IN THE LAPAROSCOPIC COMMON BILE DUCT EXPLORATION (LCBDE) DURING A CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2024. WHEN THE PATIENT HAD A CHOLECYSTECTOMY WITH AN INTRAOPERATIVE CHOLANGIOGRAM (IOC) IN THE LAPAROSCOPIC COMMON BILE DUCT EXPLORATION (LCBDE) ON (B)(6) 2024. THE PHYSICIAN REPORTED THE PATIENT PRESENTED WITH BILE DUCT LEAK ON CT SCAN. ON (B)(6) 2024, THE PATIENT WAS SCHEDULED FOR AN ERCP FOLLOW UP FOR A MEDICAL INTERVENTION. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430068 SPYGLASS DISCOVER DIGITAL CATHETER CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN BOSTON SCIENTIFIC CORPORATION M00546780 08714729994183

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other