BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPYSCOPE DS ACCESS & DELIVERY CATHETER

    MDR report key: 6884781 · Received September 21, 2017

    Report

    Report Number
    3005099803-2017-02807
    Event Type
    Death
    Date Received
    September 21, 2017
    Date of Event
    August 25, 2017
    Report Date
    August 25, 2017
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FBN
    PMA / PMN Number
    K142922
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. 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.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2017-02848 PERTAINS TO THE SPYGLASS IRRIGATION PUMP. MANUFACTURER REPORT # 3005099803-2017-02807 PERTAINS TO THE SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER AND A SPYGLASS IRRIGATION PUMP WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH SPYGLASS DS PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PATIENT RECEIVED CONSCIOUS SEDATION, MIDAZOLAM AND FENTANOL. IT WAS REPORTED THAT THE PATIENT HAD A PLASTIC STENT IN SITU REMOVED PRIOR TO SPYSCOPE DS INSERTION. REPORTEDLY, ALTHOUGH THE TUBING INSIDE THE NORMAL SALINE BOTTLE WAS CURLED UPWARDS, THE SALINE IRRIGATION APPEARED TO FLOW THROUGHOUT THE PROCEDURE. THE PATIENT EXPERIENCED A CARDIAC ARREST APPROXIMATELY 10 MINUTES INTO THE PROCEDURE. THE PATIENT¿S O2 SATURATION LEVELS DROPPED AND THE PATIENT THEN SHOWED ¿ PHYSICAL SIGNS OF CEREBRAL- VASCULAR ACCIDENT¿. ACCORDING TO THE PHYSICIAN, THE AIR EMBOLISM WAS CAUSED BY SALINE IRRIGATED THROUGH THE SPYSCOPE DS ONTO TRAPPED AIR IN THE LEFT HEPATIC LOBE WHICH WAS A RESULT OF A PLASTIC STENT IN SITU THAT WAS REMOVED PRIOR TO SPYSCOPE DS INSERTION. THIS CAUSED AIR ABSORPTION INTO THE VENOUS SYSTEM. REPORTEDLY, THE PATIENT ALSO HAD AN ARTERIAL SHUNT (EXACT LOCATION UNKNOWN) WHICH CAUSED THE AIR EMBOLISM TO BECOME ARTERIAL, SUBSEQUENTLY, TRAVELING UP TO THE BRAIN CAUSING THE CARDIAC ARREST AND CEREBRAL EVENT RESULTING IN THE PATIENT¿S DEATH. THE RESULTS OF THE CORONER¿S INQUEST WILL TAKE UP TO 18 MONTHS TO BE RELEASED. ADDITIONALLY, PER THE PHYSICIAN THE IRRIGATION TUBE SET, THE IRRIGATION PUMP AND SPYDS SCOPE DID NOT CONTRIBUTE TO THE CARDIAC ARREST. IN ADDITION, THE MANUFACTURER OF THE PLASTIC STENT IS UNKNOWN. REPORTEDLY, THE CUSTOMER TYPICALLY USES COOK PLASTIC STENTS. ATTEMPTS WERE MADE TO GET MORE DEFINITIVE INFORMATION REGARDING THIS EVENT, HOWEVER NO ADDITIONAL INFORMATION IS AVAILABLE AND WILL ONLY BE AVAILABLE UNLESS THE POST MORTEM REPORT IS PROVIDED TO BOSTON SCIENTIFIC.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2017-02848 PERTAINS TO THE SPYGLASS IRRIGATION PUMP. MANUFACTURER REPORT # 3005099803-2017-02807 PERTAINS TO THE SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER AND A SPYGLASS IRRIGATION PUMP WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH SPYGLASS DS PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE PATIENT RECEIVED CONSCIOUS SEDATION, MIDAZOLAM AND FENTANOL. IT WAS REPORTED THAT THE PATIENT HAD A PLASTIC STENT IN SITU REMOVED PRIOR TO SPYSCOPE DS INSERTION. REPORTEDLY, ALTHOUGH THE TUBING INSIDE THE NORMAL SALINE BOTTLE WAS CURLED UPWARDS, THE SALINE IRRIGATION APPEARED TO FLOW THROUGHOUT THE PROCEDURE. THE PATIENT EXPERIENCED A CARDIAC ARREST APPROXIMATELY 10 MINUTES INTO THE PROCEDURE. THE PATIENT¿S O2 SATURATION LEVELS DROPPED AND THE PATIENT THEN SHOWED ¿ PHYSICAL SIGNS OF CEREBRAL- VASCULAR ACCIDENT¿. ACCORDING TO THE PHYSICIAN, THE AIR EMBOLISM WAS CAUSED BY SALINE IRRIGATED THROUGH THE SPYSCOPE DS ONTO TRAPPED AIR IN THE LEFT HEPATIC LOBE WHICH WAS A RESULT OF A PLASTIC STENT IN SITU THAT WAS REMOVED PRIOR TO SPYSCOPE DS INSERTION. THIS CAUSED AIR ABSORPTION INTO THE VENOUS SYSTEM. REPORTEDLY, THE PATIENT ALSO HAD AN ARTERIAL SHUNT (EXACT LOCATION UNKNOWN) WHICH CAUSED THE AIR EMBOLISM TO BECOME ARTERIAL, SUBSEQUENTLY, TRAVELING UP TO THE BRAIN CAUSING THE CARDIAC ARREST AND CEREBRAL EVENT RESULTING IN THE PATIENT¿S DEATH. THE RESULTS OF THE CORONER¿S INQUEST WILL TAKE UP TO 18 MONTHS TO BE RELEASED. ADDITIONALLY, PER THE PHYSICIAN THE IRRIGATION TUBE SET, THE IRRIGATION PUMP AND SPYDS SCOPE DID NOT CONTRIBUTE TO THE CARDIAC ARREST. IN ADDITION, THE MANUFACTURER OF THE PLASTIC STENT IS UNKNOWN. REPORTEDLY, THE CUSTOMER TYPICALLY USES COOK PLASTIC STENTS. ATTEMPTS WERE MADE TO GET MORE DEFINITIVE INFORMATION REGARDING THIS EVENT, HOWEVER NO ADDITIONAL INFORMATION IS AVAILABLE AND WILL ONLY BE AVAILABLE UNLESS THE POST MORTEM REPORT IS PROVIDED TO BOSTON SCIENTIFIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664400 SPYSCOPE DS ACCESS & DELIVERY CATHETER CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN BOSTON SCIENTIFIC - MARLBOROUGH M00546600

    Patients

    Seq Age Sex Outcome Treatment
    1 Death