BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYSCOPE DS ACCESS & DELIVERY CATHETER

    MDR report key: 7208983 · Received January 22, 2018

    Report

    Report Number
    3005099803-2018-00005
    Event Type
    Malfunction
    Date Received
    January 22, 2018
    Date of Event
    December 22, 2017
    Report Date
    December 26, 2017
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FBN
    UDI-DI
    08714729863236
    PMA / PMN Number
    K142922
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL ASSESSMENT WAS PERFORMED AFTER DISINFECTION. 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. AS RECEIVED, THE WORKING CHANNEL SLEEVE PROTRUDED FROM THE DISTAL CAP, CONFIRMING THE COMPLAINT. THE TIPS OF THE PROTRUDING WORKING CHANNEL SLEEVE WERE FRAYED. THE WORKING CHANNEL SLEEVE PROTRUDED WITH THE SMALL AND LARGE KNOBS ARTICULATED IN BOTH DIRECTIONS. THE DISTAL TIP WAS CUT. THE DISTAL CAP WAS REMOVED. THE WORKING CHANNEL SLEEVE PROTRUDED FROM THE PEBAX. THE CATHETER WAS CUT OPEN USING THE CUTTING FIXTURE. THE CATHETER WAS PEELED OPEN TO REVEAL THE ENTIRE WORKING CHANNEL SLEEVE. THE PROXIMAL END OF THE WORKING CHANNEL SLEEVE DID NOT APPEAR TO BE BONDED. THE WORKING CHANNEL SLEEVE FELL OUT WHILE EXAMINING ITS PROXIMAL END. WITNESS MARKS WERE NOTED ON THE PEBAX. THERE DOES APPEAR TO BE EVIDENCE OF ADHESION AT BOND A. A RIPPLE IN THE PEBAX WALL WAS NOTED AT THE PROXIMAL END OF BOND A. A KINK/ELEVATOR MARK ON THE CATHETER WAS NOTED. THE COMPLAINT WAS CONSISTENT WITH THE REPORTED EVENT OF WORKING CHANNEL SLEEVE 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. A SEARCH OF THE COMPLAINT DATABASE CONFIRMED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DIGITAL ACCESS & DELIVERY CATHETER WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER USING THE SPYBITE IT WAS NOTICED THAT THE WORKING CHANNEL SLEEVE OF THE SPYSCOPE DS PROTRUDED. ADDITIONALLY, THE SPYSCOPE DS IMAGE WAS LOST TOWARDS THE END OF THE PROCEDURE. REPORTEDLY, NO PART OF THE DEVICE DETACHED. 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 STABLE.

    Additional Manufacturer Narrative · 1

    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 & DELIVERY CATHETER WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER USING THE SPYBITE IT WAS NOTICED THAT THE WORKING CHANNEL SLEEVE OF THE SPYSCOPE DS PROTRUDED. ADDITIONALLY, THE SPYSCOPE DS IMAGE WAS LOST TOWARDS THE END OF THE PROCEDURE. REPORTEDLY, NO PART OF THE DEVICE DETACHED. 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 STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53137 SPYSCOPE DS ACCESS & DELIVERY CATHETER CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN BOSTON SCIENTIFIC - SPENCER M00546600 21482712 08714729863236

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR