BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYSCOPE DS ACCESS & DELIVERY CATHETER

    MDR report key: 7348534 · Received March 19, 2018

    Report

    Report Number
    3005099803-2018-00762
    Event Type
    Malfunction
    Date Received
    March 19, 2018
    Date of Event
    February 2, 2018
    Report Date
    February 22, 2018
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FBN
    UDI-DI
    08714729863236
    PMA / PMN Number
    K142922
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL ASSESSMENT WAS PERFORMED AFTER DISINFECTION. THE WORKING CHANNEL SLEEVE DID NOT PROTRUDE WHEN RECEIVED. HOWEVER, MAXIMUM WORKING CHANNEL SLEEVE PROTRUSION WAS NOTED WHEN THE SMALL KNOB WAS ARTICULATED COUNTERCLOCKWISE AND THE LARGE KNOB WAS ARTICULATED CLOCKWISE. 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 LIVE 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. IT WAS FOUND DURING THE INVESTIGATION OF THE RETURNED SPYSCOPE DS THAT THE WORKING CHANNEL SLEEVE WAS PROTRUDING. BASED ON THE INVESTIGATION AND THE RECEIPT CONDITION/FUNCTIONALITY, THE COMPLAINT CONCLUSION INVESTIGATION CODE SELECTED FOR THE WORKING CHANNEL SLEEVE PROTRUSION ISSUE IS MANUFACTURING PROCESS DESIGN. THERE IS AN INVESTIGATION IN PLACE 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 ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH SPYGLASS PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SPYSCOPE DS IMAGE JUST SUDDENLY WENT BLACK. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE FINE. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING: WORKING CHANNEL SLEEVE PROTRUDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193724 SPYSCOPE DS ACCESS & DELIVERY CATHETER CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN BOSTON SCIENTIFIC - SPENCER M00546600 21518630 08714729863236

    Patients

    Seq Age Sex Outcome Treatment
    1