BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYSCOPE DS ACCESS & DELIVERY CATHETER

    MDR report key: 7411572 · Received April 10, 2018

    Report

    Report Number
    3005099803-2018-01108
    Event Type
    Malfunction
    Date Received
    April 10, 2018
    Date of Event
    March 16, 2018
    Report Date
    March 16, 2018
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FBN
    UDI-DI
    08714729863236
    PMA / PMN Number
    K142922
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 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.

    Additional Manufacturer Narrative · 1

    A VISUAL ASSESSMENT WAS PERFORMED AFTER DISINFECTION. THE CATHETER WAS KINKED IN SEVERAL LOCATIONS, BEGINNING NEAR THE DISTAL TIP. AS RECEIVED, THE WORKING CHANNEL SLEEVE PROTRUDED, CONFIRMING THE COMPLAINT. MAXIMUM PROTRUSION WAS NOTED WHEN THE LARGE KNOB WAS ARTICULATED CLOCKWISE. 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 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. A SEARCH OF THE COMPLAINT DATABASE CONFIRMED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED BATCH.

    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) WITH CHOLANGIOSCOPY AND LITHIASIS WITH LASER PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AS SOON AS THE LASER FIBER WAS INTRODUCED INTO THE SPYSCOPE DS, IT WAS NOTICED THAT THE WORKING CHANNEL SLEEVE PROTRUDED PREVENTING PROPER VISUALIZATION OF THE LUMEN. THE PHYSICIAN DECIDED TO REMOVE THE SPYSCOPE DS AND CONTINUED WITH A PARTIAL DRAINAGE OF THE BILIARY TRACT USING A NON BSC LITHOTRIPTER. REPORTEDLY, NO PART OF THE SPYSCOPE DS DETACHED AND THERE WERE NO REPORTED ISSUES WITH THE ACCESSORY DEVICES. THE PROCEDURE WAS COMPLETED BY PLACING A NON BSC STENT INTO THE BILE DUCT. 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 VERY GOOD.

    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) WITH CHOLANGIOSCOPY AND LITHIASIS WITH LASER PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AS SOON AS THE LASER FIBER WAS INTRODUCED INTO THE SPYSCOPE DS, IT WAS NOTICED THAT THE WORKING CHANNEL SLEEVE PROTRUDED PREVENTING PROPER VISUALIZATION OF THE LUMEN. THE PHYSICIAN DECIDED TO REMOVE THE SPYSCOPE DS AND CONTINUED WITH A PARTIAL DRAINAGE OF THE BILIARY TRACT USING A NON BSC LITHOTRIPTER. REPORTEDLY, NO PART OF THE SPYSCOPE DS DETACHED AND THERE WERE NO REPORTED ISSUES WITH THE ACCESSORY DEVICES. THE PROCEDURE WAS COMPLETED BY PLACING A NON BSC STENT INTO THE BILE DUCT. 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 VERY GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259086 SPYSCOPE DS ACCESS & DELIVERY CATHETER CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN BOSTON SCIENTIFIC - SPENCER M00546600 21709835 08714729863236

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR