BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYSCOPE DS II ACCESS & DELIVERY CATHETER

    MDR report key: 16104645 · Received January 5, 2023

    Report

    Report Number
    3005099803-2022-07990
    Event Type
    Malfunction
    Date Received
    January 5, 2023
    Date of Event
    December 7, 2022
    Report Date
    April 21, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FBN
    UDI-DI
    08714729965404
    PMA / PMN Number
    K183636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. IMDRF IMPACT CODE F1001 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF ABORTED/CANCELLED PROCEDURE.

    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 IMPACT CODE F1001 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF ABORTED/CANCELLED PROCEDURE. BLOCK H10: THE RETURNED SPYSCOPE DS II WAS ANALYZED, AND A VISUAL EVALUATION WAS PERFORMED. ELEVATOR MARKS WERE NOTED ON THE SHAFT OF THE CATHETER. ELEVATOR MARKS WERE MEASURED APPROXIMATELY 36MM AND 44MM FROM THE TIP. NO DAMAGE WAS NOTED. WITNESS MARKS WERE OBSERVED ON THE CONTACTS OF THE UMBILICUS CONNECTOR, INDICATING IT WAS CONNECTED TO A CONTROLLER. AN IMAGE ASSESSMENT FOR VISUALIZATION WAS PERFORMED. THE DEVICE WAS PLUGGED INTO THE CONTROLLER. A LIVE, CLEAR IMAGE WAS DISPLAYED. NO PROBLEMS WERE OBSERVED WITH PHYSICAL CONNECTIVITY OF THE DEVICE. THE UMBILICUS CONNECTOR WAS VISUALLY INSPECTED, AND NO DAMAGE OR DEFECTS WERE NOTED. THE DEVICE WAS FULLY ARTICULATED IN ALL DIRECTIONS; NO PROBLEMS WERE IDENTIFIED WITH THE IMAGE. X-RAY IMAGING OF THE DISTAL TIP SHOWED NO PROBLEMS WITH THE REDISTRIBUTION LAYER (RDL) OR THRU-SILICON VIAS (TSVS). IT WAS NOTED THE CAMERA WIRE WAS DAMAGED AT THE STEERING RING. X-RAY IMAGING OF THE HANDLE SHOWED NO PROBLEM WITH THE PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) OR CAMERA WIRES. THE HANDLE WAS OPENED AND THE COMPONENTS WITHIN WERE VISUALLY INSPECTED. IT WAS NOTED THAT THERE WAS PROCEDURAL RESIDUE ON THE PLASTIC OPTIC FIBERS (POFS) AND CAMERA WIRE IN THE BREAKOUT REGION, INDICATED PROCEDURAL FLUIDS HAD FLOWED BACK UP THE OPTICS LUMEN INTO THE HANDLE DURING USE. THE TIP WAS BLOCKED, AND SALINE WAS FLUSHED THROUGH THE IRRIGATION TUBING TO INDUCE BACKFLOW OF SALINE INTO THE OPTICS LUMEN. THIS CAUSED THE IMAGE TO BE DISRUPTED, WITH BLUE/ORANGE LINES ACROSS THE SCREEN AND A PURPLE HUE, LEADING TO A FULL LOSS OF IMAGE. THE SALINE WAS DRAINED FROM THE OPTICS LUMEN AND THE IMAGE WAS RESTORED. THE REPORTED COMPLAINT WAS CONFIRMED. DURING PRODUCT ANALYSIS, IT WAS NOTED THAT PROCEDURAL RESIDUE REMAINED AT THE TOP OF THE OPTICS LUMEN IN THE BREAKOUT. THE OPTICS LUMEN WAS FILLED WITH SALINE, AND THE IMAGE WAS DISRUPTED. DRAINING THE OPTICS LUMEN RESULTED IN THE RESTORATION OF THE IMAGE. THE IMAGE SIGNAL DOES NOT WITHSTAND THE CHANGE IN CAPACITANCE CREATED BY THE INTRODUCTION OF SALINE INTO THE OPTICS LUMEN, AND PROCEDURAL FACTORS CAN CAUSE THIS FLUID TO ENTER THE OPTICS LUMEN DURING USE. AN INVESTIGATION TO ADDRESS THIS PROBLEM IS IN PROGRESS. BASED ON ALL GATHERED INFORMATION, THE PROBABLE CAUSE FOR THE IMAGE PROBLEM IS DUE TO FLUID IN THE OPTICS LUMEN IS TRACED TO DEVICE DESIGN, WHICH INDICATES THAT THE PROBLEMS ARE TRACED TO THE DESIGN SPECIFICATIONS. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU) / PRODUCT LABEL.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO TWO SPYSCOPE DS II ACCESS & DELIVERY CATHETER THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II WAS USED DURING A LITHOTRIPSY PROCEDURE PERFORMED (B)(6) 2022. DURING THE PROCEDURE, WHILE IN THE PATIENT'S BILIARY TRACT USING THE AUTOLITH PROBE TO BREAK UP THE STONES, THERE WAS INTERFERENCE WITH THE IMAGE ON THE MONITOR. AFTER A FEW MOMENTS THE INTERFERENCE SUBSIDED AND AN ATTEMPT WAS MADE TO INSERT THE SPYGLASS RETRIEVAL BASKET, BUT IT DID NOT PASS THROUGH THE WORKING CHANNEL. IT WAS ABANDONED AFTER SEVERAL ATTEMPTS. THE AUTOLITH PROBE ALSO BEGAN TO PRESENT RESISTANCE WHEN PASSING THROUGH THE WORKING CHANNEL. AROUND THE THIRTIETH HOUR OF THE PROCEDURE, THE TRANSMISSION WAS INTERRUPTED ON THE SCREEN MONITOR AND ONLY THE THREE GRAY DOTS INDICATING TIMEOUT WERE VISIBLE. FROM THAT MOMENT ON, THE IMAGE WAS COMPLETELY LOST. A SECOND SPYSCOPE WAS CONNECTED BUT DID NOT TRANSMIT ANY IMAGE. AFTER A FEW TROUBLESHOOTING, ALTERNATING THE SPYSCOPES THE IMAGES WERE NOT RESTORED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT AFTER THIS EVENT.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO TWO SPYSCOPE DS II ACCESS & DELIVERY CATHETER THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II WAS USED DURING A LITIASIS PROCEDURE PERFORMED (B)(6) 2022. DURING THE PROCEDURE, WHILE IN THE PATIENT'S BILIARY TRACT USING THE AUTOLITH PROBE TO BREAK UP THE STONES, THERE WAS INTERFERENCE WITH THE IMAGE ON THE MONITOR. AFTER A FEW MOMENTS THE INTERFERENCE SUBSIDED AND AN ATTEMPT WAS MADE TO INSERT THE SPYGLASS RETRIEVAL BASKET, BUT IT DID NOT PASS THROUGH THE WORKING CHANNEL. IT WAS ABANDONED AFTER SEVERAL ATTEMPTS. THE AUTOLITH PROBE ALSO BEGAN TO PRESENT RESISTANCE WHEN PASSING THROUGH THE WORKING CHANNEL. AROUND THE THIRTIETH HOUR OF THE PROCEDURE, THE TRANSMISSION WAS INTERRUPTED ON THE SCREEN MONITOR AND ONLY THE THREE GRAY DOTS INDICATING TIMEOUT WERE VISIBLE. FROM THAT MOMENT ON, THE IMAGE WAS COMPLETELY LOST. A SECOND SPYSCOPE WAS CONNECTED BUT DID NOT TRANSMIT ANY IMAGE. AFTER A FEW TROUBLESHOOTING, ALTERNATING THE SPYSCOPES THE IMAGES WERE NOT RESTORED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT AFTER THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1723834 SPYSCOPE DS II ACCESS & DELIVERY CATHETER CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN BOSTON SCIENTIFIC CORPORATION M00546610 0029860457 08714729965404

    Patients

    Seq Age Sex Outcome Treatment
    1 Male