BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYSCOPE DS ACCESS & DELIVERY CATHETER

    MDR report key: 7466110 · Received April 26, 2018

    Report

    Report Number
    3005099803-2018-01263
    Event Type
    Malfunction
    Date Received
    April 26, 2018
    Date of Event
    April 3, 2018
    Report Date
    April 3, 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 · 0

    A VISUAL ASSESSMENT WAS PERFORMED AFTER DISINFECTION. AS RECEIVED, THE WORKING CHANNEL SLEEVE PROTRUDED, CONFIRMING THE COMPLAINT. A FUNCTIONAL ASSESSMENT WAS PERFORMED. MAXIMUM WORKING CHANNEL SLEEVE PROTRUSION WAS OBSERVED WHEN THE DISTAL TIP WAS ARTICULATED BY TURNING THE LARGE 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 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 · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER WAS USED IN THE BILE DUCT DURING A CHOLANGIOSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THIS DEVICE WAS INSERTED INTO THE BILE DUCT WITH THE AID OF A GUIDEWIRE. THE GUIDEWIRE WAS THEN REMOVED. WHILE OBSERVING THE TUMOR, IT WAS NOTICED THAT THE WORKING CHANNEL SLEEVE OF THE SPYSCOPE DS PROTRUDED. REPORTEDLY, THERE WERE NO ACCESSORY DEVICE INSIDE THE SPYSCOPE DS WHEN THE WORKING CHANNEL SLEEVE PROTRUDED AND NO PART OF THE SPYSCOPE DS DEVICE WAS DETACHED. THE PROCEDURE WAS STILL COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    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.

    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 A CHOLANGIOSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THIS DEVICE WAS INSERTED INTO THE BILE DUCT WITH THE AID OF A GUIDEWIRE. THE GUIDEWIRE WAS THEN REMOVED. WHILE OBSERVING THE TUMOR, IT WAS NOTICED THAT THE WORKING CHANNEL SLEEVE OF THE SPYSCOPE DS PROTRUDED. REPORTEDLY, THERE WERE NO ACCESSORY DEVICE INSIDE THE SPYSCOPE DS WHEN THE WORKING CHANNEL SLEEVE PROTRUDED AND NO PART OF THE SPYSCOPE DS DEVICE WAS DETACHED. THE PROCEDURE WAS STILL COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306576 SPYSCOPE DS ACCESS & DELIVERY CATHETER CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN BOSTON SCIENTIFIC - SPENCER M00546600 21698122 08714729863236

    Patients

    Seq Age Sex Outcome Treatment
    1