BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYSCOPE DS ACCESS & DELIVERY CATHETER

    MDR report key: 7513850 · Received May 15, 2018

    Report

    Report Number
    3005099803-2018-01399
    Event Type
    Malfunction
    Date Received
    May 15, 2018
    Date of Event
    March 15, 2018
    Report Date
    April 23, 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

    A VISUAL ASSESSMENT WAS PERFORMED AFTER DISINFECTION. AS RECEIVED, THE WORKING CHANNEL SLEEVE PROTRUDED. THE TIPS OF THE PROTRUDING SLEEVE WERE FRAYED. MAXIMUM PROTRUSION WAS OBSERVED WHEN THE LARGE KNOB WAS ARTICULATED IN BOTH DIRECTIONS. A FUNCTIONAL ASSESSMENT WAS PERFORMED. THE COMPLAINT 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 INSERTED THROUGH THE WORKING CHANNEL PORT AND PASSED THROUGH THE WORKING CHANNEL; NO ISSUES WERE IDENTIFIED WITH THE IMAGE. A SPYBITE WAS PASSED THROUGH 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 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 INTRAHEPATIC BILE DUCT DURING AN ENDOSCOPIC BILE DUCT BIOPSY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SPYSCOPE DS IMAGE WAS DISTORTED AS THERE WAS A DOT APPEARED ON THE SCREEN AND THEN EVENTUALLY, THE VISUALIZATION WAS LOST. THE PROCEDURE WAS NOT DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; WORKING CHANNEL SLEEVE PROTRUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357705 SPYSCOPE DS ACCESS & DELIVERY CATHETER CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN BOSTON SCIENTIFIC - SPENCER M00546600 21698122 08714729863236

    Patients

    Seq Age Sex Outcome Treatment
    1