BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYSCOPE DS II ACCESS & DELIVERY CATHETER

    MDR report key: 15789475 · Received November 14, 2022

    Report

    Report Number
    3005099803-2022-06655
    Event Type
    Malfunction
    Date Received
    November 14, 2022
    Date of Event
    October 18, 2022
    Report Date
    December 8, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FBN
    PMA / PMN Number
    K183636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H10: IT WAS REPORTED THAT THE SPYSCOPE DS II HAS BEEN USED AND TESTED WITH ANOTHER CONTROLLER AND WORKED AS INTENDED. THE ABORTED PROCEDURE IS CAPTURED UNDER MDR# 3005099803-2022-06489.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO A SPYSCOPE DS II AND A SPYGLASS DS CONTROLLER USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II AND A SPYGLASS DS CONTROLLER WERE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. DURING PREPARATION, THE PORT OF THE CONTROLLER WAS NOT FUNCTIONAL WHEN THE CONNECTION CABLE FROM THE SPYSCOPE WAS PLUG. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED ON NOVEMBER 21, 2022: IT WAS REPORTED THAT THE SPYSCOPE DS II HAS BEEN USED AND TESTED WITH ANOTHER CONTROLLER AND WORKED AS INTENDED. IT WAS ALSO REPORTED THAT THE SPYGLASS DS CONTROLLER LIGHT FUNCTION DID NOT WORK, AND THE LIGHT BUTTON WOULD NOT TURN ON.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO A SPYSCOPE DS II AND A SPYGLASS DS CONTROLLER USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II AND A SPYGLASS DS CONTROLLER WERE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. DURING PREPARATION, THE PORT OF THE CONTROLLER WAS NOT FUNCTIONAL WHEN THE CONNECTION CABLE FROM THE SPYSCOPE WAS PLUG. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1831280 SPYSCOPE DS II ACCESS & DELIVERY CATHETER CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown