BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYSCOPE DS II ACCESS & DELIVERY CATHETER

    MDR report key: 10606798 · Received September 30, 2020

    Report

    Report Number
    3005099803-2020-04300
    Event Type
    Malfunction
    Date Received
    September 30, 2020
    Date of Event
    September 4, 2020
    Report Date
    November 9, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FBN
    UDI-DI
    08714729965404
    PMA / PMN Number
    K181439
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION - BLOCK D4 (CATALOG NUMBER): CORRECTED FROM 1759-02 TO 4661 CORRECTION - BLOCK G5 (PREMARKET / 510(K) #): CORRECTED FROM K142922 TO K181439 BLOCK H6 (DEVICE CODES): PROBLEM CODE 3191 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. THE CATHETER DEMONSTRATED SIGNS OF USE IN THE FORM OF ELEVATOR MARKS ALONG THE SHAFT. NO ADDITIONAL DAMAGE WAS NOTED. WITNESS MARKS WERE OBSERVED ON THE CONTACTS OF THE UMBILICUS CONNECTOR, INDICATING IT WAS CONNECTED TO A CONTROLLER. AN IMAGE ASSESSMENT WAS PERFORMED. UPON PLUGGING THE DEVICE INTO THE CONTROLLER, IT DISPLAYED A LIVE, CLEAR IMAGE. NO PROBLEMS WERE IDENTIFIED WITH THE IMAGE. NO PROBLEMS WERE OBSERVED WITH PHYSICAL CONNECTIVITY OF THE DEVICE. THE DEVICE WAS FULLY ARTICULATED IN ALL DIRECTIONS; NO PROBLEMS WERE IDENTIFIED WITH THE IMAGE. REAL-TIME X-RAY WAS USED TO IMAGE THE DISTAL TIP, INCLUDING THE THROUGH-SILICON VIAS (TSVS) , REDISTRIBUTION LAYER (RDL), AND CAMERA WIRES. NO DAMAGE WAS OBSERVED TO THE CAMERA WIRES AT OR INSIDE OF THE CAMERA HOUSING/CAP. IN THE HANDLE, NO DAMAGE WAS OBSERVED TO THE PRINTED CIRCUIT BOARD (PCB) OR CAMERA WIRES. THE HANDLE WAS OPENED AND THE CONNECTION OF THE CAMERA WIRES TO THE PCBA WAS INSPECTED. IT WAS NOTED THAT THE GLUE FEATURE DID NOT FULLY INSULATE THE CAMERA WIRES, THERE WAS DISCOLORATION INDICATIVE OF CORROSION OF THE WIRES. SINCE THE WIRES WERE NOT INSULATED AND THERE WAS EVIDENCE OF CORROSION ON THE WIRES, IT IS POSSIBLE THAT IF FLUID WAS PRESENT IN THE HANDLE IT COULD SHORT THE CONNECTION BETWEEN POWER AND GROUND, RESULTING IN THE REPORTED LOSS OF IMAGE. TWEEZERS WERE APPLIED TO BOTH WIRES SIMULTANEOUSLY AND THE IMAGE COULD BE TOGGLED OFF AND ON. THE REPORTED EVENT WAS CONFIRMED. THE PROBLEM OF THE UNIT CAN BE TRACED TO THE INSULATION OF THE CAMERA WIRES AND THE PRESENCE OF FLUID INSIDE THE HANDLE. IT IS LIKELY THAT FLUID CREATED A PATH FOR A SHORT CIRCUIT BETWEEN POWER AND GROUND, RESULTING IN THE REPORTED LOSS OF IMAGE. BASED ON ALL GATHERED INFORMATION, THE MOST PROBABLE ROOT CAUSE OF THIS COMPLAINT IS CAUSE TRACED TO COMPONENT FAILURE. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE REVEALED THAT NO ANOMALIES OR DEVIATIONS RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. 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 · 0

    NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO SPYSCOPE DS II DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE BILIARY SYSTEM ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE IMAGE OF THE SPYSCOPE DS II WAS LOST APPROXIMATELY 10 TO 15 MINUTES INTO THE PROCEDURE. A SECOND SPYSCOPE DS II WAS USED; HOWEVER, THE IMAGE WAS ALSO LOST AFTER A FEW MINUTES OF USE. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS; HOWEVER, THE ANALYSIS HAS NOT YET BEEN COMPLETED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO SPYSCOPE DS II DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE BILIARY SYSTEM ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE IMAGE OF THE SPYSCOPE DS II WAS LOST APPROXIMATELY 10 TO 15 MINUTES INTO THE PROCEDURE. A SECOND SPYSCOPE DS II WAS USED; HOWEVER, THE IMAGE WAS ALSO LOST AFTER A FEW MINUTES OF USE. 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
    1070826 SPYSCOPE DS II ACCESS & DELIVERY CATHETER CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN BOSTON SCIENTIFIC CORPORATION M00546610 0025573758 08714729965404

    Patients

    Seq Age Sex Outcome Treatment
    1