BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYSCOPE DS II ACCESS & DELIVERY CATHETER

    MDR report key: 15670869 · Received October 25, 2022

    Report

    Report Number
    3005099803-2022-06171
    Event Type
    Malfunction
    Date Received
    October 25, 2022
    Date of Event
    October 3, 2022
    Report Date
    November 1, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FBN
    UDI-DI
    08714729965404
    PMA / PMN Number
    K183636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. INITIAL REPORTER FACILITY NAME (B)(6) HOSPITAL (B)(4).

    Additional Manufacturer Narrative · 0

    BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. BLOCK E1: INITIAL REPORTER FACILITY NAME (B)(6) HOSPITAL BLOCK H2: ADDITIONAL INFORMATION BLOCK B5: DESCRIBE EVENT OR PROBLEM HAS BEEN UPDATED. BLOCK H6 (IMPACT CODES): 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 SPYSCOPE DS II WAS USED IN THE BILE DUCT DURING A PERORAL CHOLANGIOSCOPY (POCS) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE IMAGE FROM THE SPYSCOPE HAS DISAPPEARED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO A SPYSCOPE DS II AND SPY DS CONTROLLER USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II AND SPYGLASS DS CONTROLLER WERE USED IN THE BILDE DUCT DURING A PERORAL CHOLANGIOSCOPY (POCS) PROCEDURE PERFORMED ON (B)(6), 2022. DURING THE PROCEDURE, THE IMAGE FROM THE SPYSCOPE HAS DISAPPEARED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. **ADDITIONAL INFORMATION WAS RECEIVED ON OCTOBER 27, 2022** IT WAS REPORTED THAT THEY WERE SUSPECTING A DEFECT AGAINST THE CONTROLLER. THE PROBLEM IS NOT CLEAR; HOWEVER, IT WAS HANDED OVER TO TAC FOR INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2556265 SPYSCOPE DS II ACCESS & DELIVERY CATHETER CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN BOSTON SCIENTIFIC CORPORATION M00546610 08714729965404

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown