BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYSCOPE DS II ACCESS & DELIVERY CATHETER

    MDR report key: 10138961 · Received June 10, 2020

    Report

    Report Number
    3005099803-2020-02245
    Event Type
    Malfunction
    Date Received
    June 10, 2020
    Date of Event
    May 20, 2020
    Report Date
    June 10, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FBN
    UDI-DI
    08714729965404
    PMA / PMN Number
    K142922
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR 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 DURING A BILE DUCT STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SPYSCOPE WAS UNABLE TO CANNULATE PASS THE PROXIMAL BILE DUCT. IT GOT STUCK AT ABOUT 2CM FROM AMPULLA. ACCORDING TO THE PHYSICIAN, THE STONE COULD HAVE BEEN BLOCKING THE WAY AND THE DEVICE COULD NOT MANEUVER FURTHER UP THE DUCT. REPORTEDLY, THE PATIENT'S VITAL STATS WERE DECLINING, AND THEREFORE THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604656 SPYSCOPE DS II ACCESS & DELIVERY CATHETER CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN BOSTON SCIENTIFIC CORPORATION M00546610 25132474 08714729965404

    Patients

    Seq Age Sex Outcome Treatment
    1