BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPYSCOPE DS II ACCESS & DELIVERY CATHETER

    MDR report key: 11819866 · Received May 13, 2021

    Report

    Report Number
    3005099803-2021-02216
    Event Type
    Injury
    Date Received
    May 13, 2021
    Date of Event
    April 13, 2021
    Report Date
    May 13, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FBN
    UDI-DI
    08714729965404
    PMA / PMN Number
    K181439
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S EXACT WEIGHT IS (B)(6) KG. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A PROBLEM ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II ACCESS & DELIVERY CATHETER WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH SPYGLASS PROCEDURE PERFORMED ON (B)(6) 2021. AFTER THE SPYGLASS PROCEDURE, THE PATIENT WAS PRESENTED TO THE EMERGENCY ROOM LATE EVENING ON (B)(6) 2021 DUE TO UPPER QUADRANT PAIN AND RIGHT SHOULDER PAIN. IT WAS ALSO REPORTED THAT THE PAIN WAS DUE TO PERIHEPATIC FLUID ACCUMULATION AND A DRAIN WAS PLACED TO ELIMINATE THE FLUID. THE SAME SPYSCOPE DS II DEVICE WAS USED THROUGHOUT TO COMPLETE THE PROCEDURE. NO DEVICE PROBLEMS WERE REPORTED FOR THE SPYSCOPE DS II AND THE CAUSE OF THE PATIENT'S PAIN AND PERIHEPATIC FLUID ACCUMULATION WERE NOT DETERMINED. ADDITIONAL INFORMATION WAS RECEIVED ON APRIL 26, 2021 REPORTING THAT THE PATIENT WAS DOING WELL AND WAS SCHEDULED FOR A WHIPPLE PROCEDURE A WEEK LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712852 SPYSCOPE DS II ACCESS & DELIVERY CATHETER CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN BOSTON SCIENTIFIC CORPORATION M00546610 08714729965404

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R