BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYSCOPE DS ACCESS & DELIVERY CATHETER

    MDR report key: 7635414 · Received June 25, 2018

    Report

    Report Number
    3005099803-2018-02069
    Event Type
    Malfunction
    Date Received
    June 25, 2018
    Date of Event
    May 31, 2018
    Report Date
    May 31, 2018
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FBN
    UDI-DI
    08714729863236
    PMA / PMN Number
    K142922
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL ASSESSMENT WAS PERFORMED AFTER DISINFECTION. THE CATHETER WAS KINKED IN SEVERAL LOCATIONS NEAR THE DISTAL END. AS RECEIVED, THE WORKING CHANNEL SLEEVE PROTRUDED CONFIRMING THE COMPLAINT. A FUNCTIONAL ASSESSMENT WAS PERFORMED AND MAXIMUM WORKING CHANNEL SLEEVE PROTRUSION WAS OBSERVED WHEN THE DISTAL TIP WAS ARTICULATED BY TURNING THE SMALL KNOB IN THE COUNTERCLOCKWISE DIRECTION. 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 COMPLAINT INCIDENT 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

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT #: 3005099803-2018-02069 FOR THE FIRST SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER, AND 3005099803-2018-02070 FOR THE SECOND SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THROUGH THE IMAGE ON THE MONITOR THAT THE WORKING CHANNEL SLEEVE OF THE SPYSCOPE DS PROTRUDED. A SECOND SPYSCOPE DS WAS USED AND THE WORKING CHANNEL SLEEVE PROTRUDED. A SPYBITE BIOPSY FORCEPS WAS INSIDE THE SPYSCOPE DS WHEN THE WORKING CHANNEL SLEEVE PROTRUDED. NO PART OF THE SPYSCOPE DS DEVICES DETACHED AND THERE WERE NO REPORTED ISSUES WITH THE SPYBITE. 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 AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478502 SPYSCOPE DS ACCESS & DELIVERY CATHETER CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN BOSTON SCIENTIFIC - SPENCER M00546600 21637019 08714729863236

    Patients

    Seq Age Sex Outcome Treatment
    1