BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYSCOPE DS II ACCESS & DELIVERY CATHETER

    MDR report key: 11633315 · Received April 8, 2021

    Report

    Report Number
    3005099803-2021-01477
    Event Type
    Malfunction
    Date Received
    April 8, 2021
    Date of Event
    March 16, 2021
    Report Date
    April 8, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FBN
    UDI-DI
    08714729965404
    PMA / PMN Number
    K181439
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURNED SPYSCOPE DS II ACCESS & DELIVERY CATHETER WAS ANALYZED, AND A VISUAL EVALUATION NOTED THAT THE DEVICE INDICATED SIGNS OF USE IN THE FORM OF ELEVATOR MARKS. WITNESS MARKS OBSERVED ON THE CONTACTS OF THE UMBILICUS CONNECTOR INDICATE IT WAS CONNECTED TO A CONTROLLER FOR USE. THE LENGTH OF THE CATHETER AND UMBILICUS CABLE WAS VISUALLY INSPECTED; NO PROBLEMS WERE NOTED. X-RAY IMAGING OF THE DISTAL END SHOWED NO PROBLEMS WITH THE REDISTRIBUTION LAYER (RDL), THRU-SILICON VIAS (TSVS), OR CAMERA WIRES. X-RAY IMAGING OF THE HANDLE SHOWED NO DAMAGE TO THE PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) OR CAMERA WIRES. AN IMAGE TEST WAS PERFORMED. THE DEVICE WAS PLUGGED INTO THE CONTROLLER AND A CLEAR, LIVE IMAGE WAS DISPLAYED. THE DEVICE WAS FULLY ARTICULATED AND THE TIP WAS MANUALLY MANIPULATED IN ALL DIRECTIONS; NO DEGRADATION OF THE IMAGE WAS OBSERVED. THE HANDLE WAS OPENED AND THE COMPONENTS WITHIN WERE VISUALLY INSPECTED; NO INTERNAL PROBLEMS WERE DETECTED. IT WAS NOTED THAT PROCEDURAL RESIDUE WAS PRESENT ON THE DEVICE COMPONENTS IN THE BREAKOUT REGION, INDICATING THAT PROCEDURAL FLUIDS HAD FLOWED THROUGH THE OPTICS LUMEN AND INTO THE HANDLE DURING USE. TO TEST FOR THIS, SALINE WAS FLUSHED THROUGH THE IRRIGATION TUBING WITH A SYRINGE, AND THE CATHETER TIP AND WORKING PORT WERE BLOCKED TO INDUCE BACK-FLOW INTO THE OPTICS LUMEN. THIS RESULTED IN A LOSS OF IMAGE. A POOR-QUALITY IMAGE (PQI) WAS RECOVERED AFTER DRAINING THE SALINE WITH THE SYRINGE. NO OTHER PROBLEMS WITH THE DEVICE WERE NOTED. THE REPORTED EVENT WAS CONFIRMED. A DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THAT THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS. A RISK REVIEW CONFIRMED THAT THE EVENT IS ACCOUNTED FOR IN THE RISK DOCUMENTATION. THE OPTICS LUMEN IN THE SHAFT OF THE CATHETER IS THE PORTION OF THE DEVICE WHERE THE CAMERA WIRE IS ROUTED FROM THE TIP TO THE HANDLE. SEVERAL PATHWAYS AT THE TIP OF THE DEVICE WOULD ALLOW FLUID FROM THE PROCEDURE, SUCH AS SALINE, TO BACKFLOW INTO THE OPTICS LUMEN. WITH THE INTRODUCTION OF SALINE TO THE OPTICS LUMEN, A CAPACITANCE IS ADDED TO THE CAMERA SIGNAL THAT AFFECTS THE ELECTRICAL PROPERTIES AND CAN DISRUPT THE IMAGE. DURING PRODUCT ANALYSIS, IT WAS NOTED THAT PROCEDURE RESIDUE REMAINED AT THE TOP OF THE OPTICS LUMEN IN THE BREAKOUT. THE OPTICS LUMEN WAS FILLED WITH SALINE AND THE IMAGE WAS LOST. DRAINING THE OPTICS LUMEN RESULTED IN A PQI. 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. BASED ON ALL GATHERED INFORMATION, THE PROBABLE CAUSE SELECTED FOR THE IMAGE PROBLEM DUE TO FLUID IN THE OPTICS LUMEN IS CAUSE TRACED TO DEVICE DESIGN. AN INVESTIGATION TO ADDRESS THIS PROBLEM IS IN PROGRESS. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE REVEALED THAT NO ANOMALIES OR DEVIATIONS RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A SEARCH OF THE COMPLAINT DATABASE CONFIRMED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. A LABELING REVIEW WAS PERFORMED AND FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II ACCESS & DELIVERY CATHETER AND SPYGLASS DS CONTROLLER WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE SPYSCOPE DS II IMAGE WAS LOST AFTER TAKING ONE BIOPSY. ATTEMPTS MADE TO REGAIN THE IMAGE WERE NOT SUCCESSFUL. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533092 SPYSCOPE DS II ACCESS & DELIVERY CATHETER CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN BOSTON SCIENTIFIC CORPORATION M00546610 0026804006 08714729965404

    Patients

    Seq Age Sex Outcome Treatment
    1