BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYSCOPE DS II ACCESS & DELIVERY CATHETER

    MDR report key: 16104535 · Received January 5, 2023

    Report

    Report Number
    3005099803-2022-07989
    Event Type
    Malfunction
    Date Received
    January 5, 2023
    Date of Event
    December 7, 2022
    Report Date
    May 5, 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 PERFORMED: ELEVATOR MARKS AT APPROXIMATELY 37, 53, AND 64MM WERE NOTED ON THE SHAFT OF THE CATHETER. AN IMAGE ASSESSMENT FOR VISUALIZATION WAS PERFORMED. A LIVE IMAGE WAS SEEN UPON INITIAL INSERTION OF THE DEVICE. INTERACTION WITH THE DISTAL END OF THE CATHETER CAUSED IMAGE TO BE DISRUPTED AND THE INITIALIZATION SCREEN TO APPEAR. X-RAY IMAGING OF THE DISTAL TIP SHOWED NO PROBLEMS WITH THE REDISTRIBUTION LAYER (RDL). NO CAMERA WIRE DAMAGE WAS OBSERVED NEAR THE DISTAL END OR IN THE PEBAX REGION OF THE CATHETER. X-RAY IMAGING OF THE HANDLE SHOWED NO PROBLEM WITH THE BREAKOUT REGION OR CAMERA WIRES AROUND THE STRAIN RELIEF. X-RAY IMAGING SHOWS NO DAMAGE TO THE CAMERA WIRES AT THE PRINTED CIRCUIT BOARD ASSEMBLY (PCBA). THE HANDLE WAS OPENED AND THE ELECTRICAL COMPONENTS INSIDE WERE INSPECTED VISUALLY. THERE WAS PROCEDURAL RESIDUE LEFT OVER OBSERVED IN THE PLASTIC OPTIC FIBERS (POF). VISUAL INSPECTION OF THE CAMERA WIRES AT THE GLUE FEATURE SHOWED NO PROBLEMS. THE BOND OF THE GLUE FEATURE TO THE PCBA WAS INSPECTED; TWEEZERS WERE USED TO WIGGLE THE GLUE FEATURE. THE CONNECTION OF THE CAMERA WIRES TO THE PCBA WAS ALSO INSPECTED BY SLIGHTLY LIFTING THE BOTTOM OF THE GLUE FEATURE FOR EACH OF THE FOUR CAMERA WIRES USING THE TIP OF THE TWEEZERS. NO IMPACT TO IMAGE WAS SEEN AFTER THESE INTERACTIONS. THE CAMERA CABLE OF THE DEVICE WAS CURVE TRACED AND IDENTIFIED ELECTRICAL PROBLEMS WITH THE CAMERA WIRES. THE NOTABLE PROBLEMS WERE A SHORT CIRCUIT BETWEEN THE DATA + AND GROUND CAMERA WIRES AND A HIGHLY RESISTIVE/OPEN CIRCUIT BETWEEN THE GROUND AND POWER CAMERA WIRES. VISUAL ASSESSMENT OF THE CAMERA WIRES DID NOT IDENTIFY ANY DAMAGE. A GUIDEWIRE WAS PASSED THROUGH THE WORKING CHANNEL PORT AT THE HANDLE AND THE TIP OF THE GUIDEWIRE WAS SEEN EXITING THE DISTAL END OF THE CATHETER. NO PROBLEM WAS NOTED WITH DIFFICULTY TO ADVANCE ACCESSORIES. THE REPORTED COMPLAINT REGARDING VISUALIZATION WAS CONFIRMED. THE REPORTED COMPLAINT REGARDING DIFFICULTY TO ADVANCE ACCESSORIES WAS NOT CONFIRMED. DURING PRODUCT ANALYSIS, A LIVE IMAGE WAS SEEN UPON INITIAL INSERTION; HOWEVER, INTERACTING WITH THE DISTAL END OF THE CATHETER CAUSED IMAGE TO BE DISRUPTED AND THE INITIALIZATION SCREEN APPEARED. VISUAL INSPECTION OF THE DEVICE ALONG WITH X-RAY ASSESSMENT DID NOT IDENTIFY ANY PROBLEM THEREFORE THE CAMERA WIRES OF THE DEVICE WERE CURVE TRACED. THE CURVE TRACE RESULTS SHOWED A SHORT CIRCUIT BETWEEN THE DATA + AND GROUND CAMERA WIRES AND A HIGHLY RESISTIVE/OPEN CIRCUIT BETWEEN THE GROUND AND POWER CAMERA WIRES. THE RESULTS OF THE CURVE TRACE INDICATE A RANDOM FAILURE OF THE CAMERA ASSEMBLY DURING THE PROCEDURE AS THERE WERE NO MANUFACTURING DEVIATIONS NOTED DURING THE INVESTIGATION. BASED ON ALL GATHERED INFORMATION, THE PROBABLE CAUSE FOR THE IMAGE PROBLEM DUE TO CAMERA ASSEMBLY DEFECT IS CAUSE TRACED TO COMPONENT FAILURE, WHICH INDICATES THAT A RANDOM PROBLEM WITH A DEVICE COMPONENT CONTRIBUTED TO THE EVENT. 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 LITHIASIS 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
    192214 SPYSCOPE DS II ACCESS & DELIVERY CATHETER CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN BOSTON SCIENTIFIC CORPORATION M00546610 0029904487 08714729965404

    Patients

    Seq Age Sex Outcome Treatment
    1 Male