BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYSCOPE DS

    MDR report key: 8038506 · Received November 5, 2018

    Report

    Report Number
    3005099803-2018-61138
    Event Type
    Malfunction
    Date Received
    November 5, 2018
    Date of Event
    October 11, 2018
    Report Date
    December 5, 2018
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FBN
    UDI-DI
    08714729863236
    PMA / PMN Number
    K142922
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). VISUAL ASSESSMENT WAS PERFORMED. AS RECEIVED, THE WORKING CHANNEL SLEEVE (WCS) PROTRUDED. MAXIMUM WCS PROTRUSION WAS OBSERVED WHEN THE DISTAL TIP WAS ARTICULATED BY TURNING THE LARGE KNOB IN BOTH DIRECTIONS. 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 AND CLEAR 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 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]. WORKING CHANNEL SLEEVE PROTRUSION IN DEVICES MANUFACTURED POST 01MAR2018 CHANGES HAS BEEN DETERMINED TO BE A DESIGN ISSUE, THEREFORE, THE COMPLAINT INVESTIGATION CONCLUSION CODE SELECTED FOR THE WORKING CHANNEL SLEEVE PROTRUSION ISSUE IS DESIGN INADEQUATE FOR PURPOSE, WHICH INDICATES THAT PROBLEMS WERE TRACED TO DESIGN/DESIGN FEATURES OF THE DEVICE THAT DO NOT SUPPORT OR DO INTERFERE WITH THE INTENDED PURPOSE OF THE DEVICE. AN INVESTIGATION IS UNDERWAY TO ADDRESS THIS ISSUE. A DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND. IT WAS CONFIRMED THAT THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO ONE OF THE TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MFR REPORT# 3005099803-2018-61138 FOR THE SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER AND MFR REPORT# 3005099803-2018-61137 FOR THE HURRICANE RX. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER AND A HURRICANE RX WERE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN USED THE SPYSCOPE DS TO VISUALIZE A LARGE PANCREATIC STONE FOR EHL. DURING DEVICE EXCHANGE, HE NOTICED THAT THE WORKING CHANNEL SLEEVE OF THE SPYSCOPE DS WAS PROTRUDING. A GUIDEWIRE WAS INSIDE THE SPYSCOPE DS WHEN THE WORKING CHANNEL SLEEVE PROTRUDED AND THERE REPORTED ISSUES WITH THE GUIDEWIRE. WHEN THE HURRICANE RX WAS ALSO USED WHILE DILATING THE PANCREATIC DUCT STRICTURE, THE BALLOON BURST. REPORTEDLY, NO PART OF THE DEVICES DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SECOND SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER AND A SECOND HURRICANE RX. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    NOTE: THIS REPORT PERTAINS TO ONE OF THE TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MFR REPORT# 3005099803-2018-61138 FOR THE SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER AND MFR REPORT# 3005099803-2018-61137 FOR THE HURRICANE RX. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER AND A HURRICANE RX WERE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN USED THE SPYSCOPE DS TO VISUALIZE A LARGE PANCREATIC STONE FOR EHL. DURING DEVICE EXCHANGE, HE NOTICED THAT THE WORKING CHANNEL SLEEVE OF THE SPYSCOPE DS WAS PROTRUDING. A GUIDEWIRE WAS INSIDE THE SPYSCOPE DS WHEN THE WORKING CHANNEL SLEEVE PROTRUDED AND THERE REPORTED ISSUES WITH THE GUIDEWIRE. WHEN THE HURRICANE RX WAS ALSO USED WHILE DILATING THE PANCREATIC DUCT STRICTURE, THE BALLOON BURST. REPORTEDLY, NO PART OF THE DEVICES DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SECOND SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER AND A SECOND HURRICANE RX. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877120 SPYSCOPE DS CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN BOSTON SCIENTIFIC CORPORATION M00546600 0022386825 08714729863236

    Patients

    Seq Age Sex Outcome Treatment
    1