BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYSCOPE DS

    MDR report key: 8240714 · Received January 11, 2019

    Report

    Report Number
    3005099803-2018-62418
    Event Type
    Malfunction
    Date Received
    January 11, 2019
    Date of Event
    December 19, 2018
    Report Date
    February 21, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FBN
    UDI-DI
    08714729863236
    PMA / PMN Number
    K142922
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H6 (DEVICE CODES): PROBLEM CODE 2979 CAPTURES THE REPORTABLE EVENT OF WORKING CHANNEL SLEEVE PROTRUSION. H10: VISUAL ASSESSMENT WAS PERFORMED AFTER DISINFECTION. AS RECEIVED, THE WORKING CHANNEL SLEEVE (WCS) PROTRUDED. MAXIMUM WCS PROTRUSION WAS OBSERVED 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. THE WCS WAS REMOVED. WITNESS MARKS WERE NOTED ON THE PEBAX. THE WHITE AND CLEAR AREAS ALONG BOND A, APPEARED 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 DEFICIENCY. 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 (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH SPYGLASS AND CHOLANGIOSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE WORKING CHANNEL SLEEVE OF THE SPYSCOPE DS PROTRUDED. THE SPYSCOPE DS DEVICE WAS REMOVED AND THE PROCEDURE WAS CONTINUED WITH A SECOND SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER. HOWEVER, THE WORKING CHANNEL SLEEVE ALSO PROTRUDED. AN EHL PROBE WAS INSIDE THE TWO SPYSCOPE DS WHEN THE WORKING CHANNEL SLEEVE PROTRUDED. REPORTEDLY, NO PART OF THE SPYSCOPE DS DEVICES DETACHED AND THERE WERE NO REPORTED ISSUES WITH THE EHL PROBE. THE PROCEDURE WAS COMPLETED WITH A THIRD SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER. 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH SPYGLASS AND CHOLANGIOSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE WORKING CHANNEL SLEEVE OF THE SPYSCOPE DS PROTRUDED. THE SPYSCOPE DS DEVICE WAS REMOVED AND THE PROCEDURE WAS CONTINUED WITH A SECOND SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER. HOWEVER, THE WORKING CHANNEL SLEEVE ALSO PROTRUDED. AN EHL PROBE WAS INSIDE THE TWO SPYSCOPE DS WHEN THE WORKING CHANNEL SLEEVE PROTRUDED. REPORTEDLY, NO PART OF THE SPYSCOPE DS DEVICES DETACHED AND THERE WERE NO REPORTED ISSUES WITH THE EHL PROBE. THE PROCEDURE WAS COMPLETED WITH A THIRD SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33757 SPYSCOPE DS CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN BOSTON SCIENTIFIC CORPORATION M00546600 0021552356 08714729863236

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR