BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPYBITE

    MDR report key: 19342686 · Received May 17, 2024

    Report

    Report Number
    3005099803-2024-02270
    Event Type
    Death
    Date Received
    May 17, 2024
    Date of Event
    April 17, 2024
    Report Date
    June 17, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCL
    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

    BLOCK A2: PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. BLOCK H2: ADDITIONAL INFORMATION: UPDATED CONTENT IN B5 (EVENT DESCRIPTION) AND H6 (IMPACT CODES) BASED ON ADDITIONAL INFORMATION RECEIVED ON MAY 24, 2024. 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.

    Additional Manufacturer Narrative · 0

    BLOCK A2: PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYBITE BIOPSY FORCEPS 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. THERE WAS NO ALLEGED MALFUNCTION NOTED ON THE SPYSCOPE DS II, SPYBITE AND EXTRACTOR PRO BALLOON DURING USE. THE PROCEDURE WAS COMPLETED WITH THESE DEVICES. 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. IN THE PHYSICIAN'S ASSESSMENT, THE SPYSCOPE DS II, SPYBITE BIOPSY FORCEPS, AND THE EXTRACTOR PRO DID NOT CONTRIBUTE TO THE PATIENT'S SEPSIS. ADDITIONAL INFORMATION 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.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYBITE BIOPSY FORCEPS 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. THERE WAS NO ALLEGED MALFUNCTION NOTED ON THE SPYSCOPE DS II, SPYBITE AND EXTRACTOR PRO BALLOON DURING USE. THE PROCEDURE WAS COMPLETED WITH THESE DEVICES. 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. IN THE PHYSICIAN'S ASSESSMENT, THE SPYSCOPE DS II, SPYBITE BIOPSY FORCEPS, AND THE EXTRACTOR PRO DID NOT CONTRIBUTE TO THE PATIENT'S SEPSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744376 SPYBITE FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death