BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPYSCOPE DS II ACCESS & DELIVERY CATHETER

    MDR report key: 19259025 · Received May 7, 2024

    Report

    Report Number
    3005099803-2024-02101
    Event Type
    Death
    Date Received
    May 7, 2024
    Date of Event
    April 17, 2024
    Report Date
    June 12, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FBN
    UDI-DI
    08714729965404
    PMA / PMN Number
    K183636
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: BLOCK H6: IMDRF PATIENT CODE E0306 CAPTURES THE REPORTABLE EVENT OF SEPSIS. IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF PATIENT'S DEATH. IMDRF PATIENT CODE E233605 CAPTURES THE REPORTABLE EVENT OF SEPTIC SHOCK. IMDRF IMPACT CODE F2303 CAPTURES THE REPORTABLE EVENT OF MEDICATION REQUIRED. BLOCK H10: CORRECTION TO BLOCK B3 (DATE OF EVENT). UPDATE TO BLOCK H6 (PATIENT CODE). UPDATE TO BLOCK H6 (PATIENT IMPACT CODE).

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF PATIENT CODE E0306 CAPTURES THE REPORTABLE EVENT OF SEPSIS. IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF PATIENT'S DEATH.

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF PATIENT CODE E0306 CAPTURES THE REPORTABLE EVENT OF SEPSIS. IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF PATIENT'S DEATH. IMDRF PATIENT CODE E233605 CAPTURES THE REPORTABLE EVENT OF SEPTIC SHOCK. IMDRF IMPACT CODE F2303 CAPTURES THE REPORTABLE EVENT OF MEDICATION REQUIRED. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL DEVICE REQUIRED. BLOCK H10: CORRECTION TO BLOCK B3 (DATE OF EVENT). UPDATE TO BLOCK H6 (PATIENT CODE). UPDATE TO BLOCK H6 (PATIENT IMPACT CODE).

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II ACCESS & DELIVERY CATHETER WAS USED IN THE BILIARY TREE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED FOR THE DIAGNOSIS OF BILIARY STRICTURE ON (B)(6) 2024. DURING THE PROCEDURE, THE SPYSCOPE DS II WAS USED TOGETHER WITH A SPYBITE BIOPSY FORCEPS AND AN EXTRACTOR PRO TO REMOVE THE STONES. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THE PHYSICIAN REPORTED THAT THE PATIENT DEVELOPED SEPSIS ON (B)(6) 2024, AND WAS UNDER MEDICINE CONTROL. ON (B)(6) 2024, THE PATIENT HAD SEPTIC SHOCK WHICH LED TO DEATH ON THE SAME DAY. REPORTEDLY, IT WAS UNKNOWN IF THE PATIENT HAS ANY CO-MORBIDITIES THAT COULD HAVE CONTRIBUTED TO THE EVENT, HOWEVER, THE RESULT OF THE BIOPSY WAS POSITIVE CHOLANGIOCARCINOMA. ADDITIONAL INFORMATION WAS RECEIVED ON APRIL 24, 2024: IT WAS REPORTED THAT THERE WAS NO ALLEGED MALFUNCTION OF THE SPYSCOPE DS II, SPYBITE AND EXTRACTOR PRO BALLOON WHEN USED DURING THE PROCEDURE. IN THE PHYSICIAN'S ASSESSMENT, THESE DEVICES DID NOT CONTRIBUTE TO THE PATIENT'S SEPSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II ACCESS & DELIVERY CATHETER WAS USED IN THE BILIARY TREE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED FOR THE DIAGNOSIS OF BILIARY STRICTURE ON (B)(6) 2024. DURING THE PROCEDURE, THE SPYSCOPE DS II WAS USED TOGETHER WITH A SPYBITE BIOPSY FORCEPS AND AN EXTRACTOR PRO TO REMOVE THE STONES. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THE PHYSICIAN REPORTED THAT THE PATIENT DEVELOPED SEPSIS ON (B)(6) 2024, AND WAS UNDER MEDICINE CONTROL. ON (B)(6) 2024, THE PATIENT HAD SEPTIC SHOCK WHICH LED TO DEATH ON THE SAME DAY. REPORTEDLY, IT WAS UNKNOWN IF THE PATIENT HAS ANY CO-MORBIDITIES THAT COULD HAVE CONTRIBUTED TO THE EVENT, HOWEVER, THE RESULT OF THE BIOPSY WAS POSITIVE CHOLANGIOCARCINOMA.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II ACCESS & DELIVERY CATHETER WAS USED IN THE BILIARY TREE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED FOR THE DIAGNOSIS OF BILIARY STRICTURE ON (B)(6) 2024. DURING THE PROCEDURE, THE SPYSCOPE DS II WAS USED TOGETHER WITH A SPYBITE BIOPSY FORCEPS AND AN EXTRACTOR PRO TO REMOVE THE STONES. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THE PHYSICIAN REPORTED THAT THE PATIENT DEVELOPED SEPSIS ON (B)(6) 2024, AND WAS UNDER MEDICINE CONTROL. ON (B)(6) 2024, THE PATIENT HAD SEPTIC SHOCK WHICH LED TO DEATH ON THE SAME DAY. REPORTEDLY, IT WAS UNKNOWN IF THE PATIENT HAS ANY CO-MORBIDITIES THAT COULD HAVE CONTRIBUTED TO THE EVENT, HOWEVER, THE RESULT OF THE BIOPSY WAS POSITIVE CHOLANGIOCARCINOMA. ADDITIONAL INFORMATION WAS RECEIVED ON APRIL 24, 2024: IT WAS REPORTED THAT THERE WAS NO ALLEGED MALFUNCTION OF THE SPYSCOPE DS II, SPYBITE AND EXTRACTOR PRO BALLOON WHEN USED DURING THE PROCEDURE. IN THE PHYSICIAN'S ASSESSMENT, THESE DEVICES DID NOT CONTRIBUTE TO THE PATIENT'S SEPSIS. ADDITIONAL INFORMATION WAS RECEIVED ON MAY 24, 2024: IT WAS REPORTED THAT A SPHINCTEROTOMY WAS PERFORMED ON THE PATIENT FROM A DIFFERENT HEALTH CARE FACILITY PRIOR TO THE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE USING THE SPYSCOPE DS II. THE 7FR ADVANIX STENT THAT WAS IMPLANTED WAS REMOVED TO PROCEED WITH THE SPYGLASS PROCEDURE AND A 10FR/7 ADVANIX RX STENT WAS THEN PLACED AFTER TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381989 SPYSCOPE DS II ACCESS & DELIVERY CATHETER CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN BOSTON SCIENTIFIC CORPORATION M00546610 0032483535 08714729965404

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death