BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYSCOPE DS

    MDR report key: 8035065 · Received November 2, 2018

    Report

    Report Number
    3005099803-2018-61103
    Event Type
    Malfunction
    Date Received
    November 2, 2018
    Date of Event
    October 10, 2018
    Report Date
    January 10, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FBN
    UDI-DI
    08714729863236
    PMA / PMN Number
    K142922
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6 (DEVICE CODES): THE PROBLEM CODE 2979 CAPTURES THE REPORTABLE EVENT OF WORKING CHANNEL SLEEVE PROTRUSION. BLOCK H10: VISUAL ASSESSMENT WAS PERFORMED. AS RECEIVED, THE WORKING CHANNEL SLEEVE PROTRUDED, CONFIRMING THE COMPLAINT. MAXIMUM PROTRUSION REMAINED CONSISTENT WHEN THE DISTAL TIP WAS ARTICULATED BY TURNING THE KNOBS IN ALL DIRECTIONS. THE DISTAL TIP WAS CUT. THE DISTAL CAP WAS REMOVED. THE CATHETER WAS CUT OPEN USING THE CUTTING FIXTURE, HOWEVER THE WORKING CHANNEL SLEEVE STRETCHED AS THE CUTTING FIXTURE WAS BEING USED. 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 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 DID NOT IDENTIFY EVIDENCE OF DEVIATIONS OR NON-CONFORMANCES IN THE MANUFACTURING PROCESSES THAT COULD CONTRIBUTE TO THE COMPLAINT. THE DHR REVIEW CONFIRMS THAT THE ACCEPTED DEVICE MET ALL MANUFACTURING SPECIFICATIONS.

    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 COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHILE THE SPYBITE BIOPSY FORCEPS WAS PASSED DOWN THROUGH THE SCOPE, THE WORKING CHANNEL SLEEVE OF THE SPYSCOPE PROTRUDED. REPORTEDLY, NO PART OF THE SPYSCOPE DS DEVICE DETACHED AND THERE WERE NO REPORTED ISSUES WITH THE ACCESSORY DEVICE. ANOTHER SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER WAS INSERTED INTO THE PATIENT. THE PHYSICIAN HAD THE DEVICE IN A VERY TORTUOUS POSITION WHICH CAUSED THE SPYSCOPE DS TO KINK, BUT THEY WERE ABLE TO COMPLETE THE PROCEDURE WITH THE SECOND SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER. THERE WERE NO USER INJURIES NOR PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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 COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHILE THE SPYBITE BIOPSY FORCEPS WAS PASSED DOWN THROUGH THE SCOPE, THE WORKING CHANNEL SLEEVE OF THE SPYSCOPE PROTRUDED. REPORTEDLY, NO PART OF THE SPYSCOPE DS DEVICE DETACHED AND THERE WERE NO REPORTED ISSUES WITH THE ACCESSORY DEVICE. ANOTHER SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER WAS INSERTED INTO THE PATIENT. THE PHYSICIAN HAD THE DEVICE IN A VERY TORTUOUS POSITION WHICH CAUSED THE SPYSCOPE DS TO KINK, BUT THEY WERE ABLE TO COMPLETE THE PROCEDURE WITH THE SECOND SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER. THERE WERE NO USER INJURIES NOR 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
    874330 SPYSCOPE DS CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN BOSTON SCIENTIFIC CORPORATION M00546600 0022395359 08714729863236

    Patients

    Seq Age Sex Outcome Treatment
    1