BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYSCOPE DS ACCESS & DELIVERY CATHETER

    MDR report key: 7344558 · Received March 16, 2018

    Report

    Report Number
    3005099803-2018-00804
    Event Type
    Malfunction
    Date Received
    March 16, 2018
    Date of Event
    February 21, 2018
    Report Date
    February 21, 2018
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FBN
    UDI-DI
    08714729863236
    PMA / PMN Number
    K142922
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL ASSESSMENT WAS PERFORMED AFTER DISINFECTION. THE CATHETER WAS KINKED IN SEVERAL LOCATIONS, BEGINNING NEAR THE DISTAL TIP. AS RECEIVED, THE WORKING CHANNEL SLEEVE PROTRUDED, CONFIRMING THE REPORTED COMPLAINT INCIDENT OF WORKING CHANNEL SLEEVE PROTRUSION. MAXIMUM WORKING CHANNEL SLEEVE PROTRUSION WAS NOTED WHEN THE SMALL KNOB WAS ARTICULATED COUNTERCLOCKWISE. A FUNCTIONAL ASSESSMENT WAS PERFORMED. THE REPORTED COMPLAINT INCIDENT OF ¿LOSS OF VISUALIZATION¿ WAS NOT CONFIRMED BECAUSE, UPON PLUGGING THE DEVICE INTO THE CONTROLLER, IT DISPLAYED A LIVE, CLEAR IMAGE. NO ISSUES WERE IDENTIFIED WITH THE IMAGE. THE DEVICE WAS FULLY ARTICULATED IN ALL DIRECTIONS; NO ISSUES WERE IDENTIFIED WITH THE IMAGE. A GUIDEWIRE WAS BACK-LOADED THROUGH THE DISTAL END OF THE SCOPE; NO ISSUES WERE IDENTIFIED WITH THE IMAGE. A SPYBITE WAS PASSED THOUGH THE WORKING CHANNEL; NO ISSUES WERE IDENTIFIED WITH THE IMAGE. THE HANDLE WAS OPENED AND IT WAS FOUND WITHIN SPECIFICATION. THE DISTAL TIP WAS CUT. THE DISTAL CAP WAS REMOVED. THE CATHETER WAS CUT OPEN USING THE CUTTING FIXTURE. THE WORKING CHANNEL SLEEVE WAS REMOVED. WITNESS MARKS WERE NOTED ON THE PEBAX. THE WHITE AREAS ALONG BOND A APPEAR TO SHOW EVIDENCE OF ADHESION. THE COMPLAINT WAS CONSISTENT WITH THE REPORTED EVENT OF WORKING CHANNEL SLEEVE PROTRUDING. BASED ON THE INVESTIGATION RESULTS, THE UNDERLYING CAUSE OF WORKING CHANNEL SLEEVE PROTRUSION IS AN INSUFFICIENT BOND, PARTICULARLY THE SECOND HEAT CYCLE OF THE WORKING CHANNEL SLEEVE BONDING PROCESS [BOND B]. THEREFORE, THE COMPLAINT INVESTIGATION CONCLUSION CODE SELECTED FOR THE WORKING CHANNEL SLEEVE PROTRUSION ISSUE IS MANUFACTURING PROCESS DESIGN. AN INVESTIGATION IS UNDERWAY TO ADDRESS THIS ISSUE. A DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER WAS USED IN THE BILE DUCT DURING AN ORAL CHOLANGIOSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE WORKING CHANNEL SLEEVE OF THE SPYSCOPE DS PROTRUDED. DURING MANIPULATION, THE SPYSCOPE DS IMAGE DISAPPEARED. THE SYSTEM WAS RESTARTED 4 TIMES, AND THE IMAGE WAS RESTORED. REPORTEDLY, NO PART OF THE SPYSCOPE DS DETACHED AND THERE WERE NO REPORTED ISSUES WITH THE ACCESSORY DEVICE. THE PROCEDURE WAS STILL COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER WAS USED IN THE BILE DUCT DURING AN ORAL CHOLANGIOSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE WORKING CHANNEL SLEEVE OF THE SPYSCOPE DS PROTRUDED. DURING MANIPULATION, THE SPYSCOPE DS IMAGE DISAPPEARED. THE SYSTEM WAS RESTARTED 4 TIMES, AND THE IMAGE WAS RESTORED. REPORTEDLY, NO PART OF THE SPYSCOPE DS DETACHED AND THERE WERE NO REPORTED ISSUES WITH THE ACCESSORY DEVICE. THE PROCEDURE WAS STILL COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. CORRECTION AS OF APRIL 24, 2018. THERE WERE NO ACCESSORY DEVICES USED DURING THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187738 SPYSCOPE DS ACCESS & DELIVERY CATHETER CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN BOSTON SCIENTIFIC - SPENCER M00546600 21643389 08714729863236

    Patients

    Seq Age Sex Outcome Treatment
    1