BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYSCOPE DS ACCESS & DELIVERY CATHETER

    MDR report key: 7277803 · Received February 16, 2018

    Report

    Report Number
    3005099803-2018-00356
    Event Type
    Malfunction
    Date Received
    February 16, 2018
    Date of Event
    January 16, 2018
    Report Date
    January 18, 2018
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FBN
    UDI-DI
    08714729863236
    PMA / PMN Number
    K142922
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL ASSESSMENT WAS PERFORMED AFTER DISINFECTION. THE WORKING CHANNEL SLEEVE EXTENDED FROM THE DISTAL CAP WHEN RECEIVED, CONFIRMING THE COMPLAINT. THE PROXIMAL END OF THE DISTAL CAP WAS ALIGNED TO THE CAP WELD. THERE WAS EVIDENCE OF THE PRODUCTION BONDING PROCESS AND THE APPLICATION OF HEAT TO THE OUTSIDE OF THE CATHETER DURING MANUFACTURING ASSEMBLY, AS SEEN IN THE WORKING CHANNEL SLEEVE REFLOW/BOND. A FUNCTIONAL ASSESSMENT WAS PERFORMED. THE DEVICE WAS FULLY ARTICULATED IN ALL DIRECTIONS. A GUIDEWIRE WAS BACK-LOADED THROUGH THE DISTAL END OF THE SCOPE. A SPYBITE WAS PASSED THOUGH THE WORKING CHANNEL. THE DISTAL END OF THE CATHETER WAS REMOVED TO EXAMINE THE WORKING CHANNEL. THE DISTAL CAP WAS REMOVED FROM THE CATHETER FOR EXAMINATION. THE DISTAL END OF THE EXPOSED WORKING CHANNEL SLEEVE WAS TUGGED; IT DID NOT DETACH FROM THE CATHETER. THE CATHETER WAS CUT OPEN USING THE CUTTING FIXTURE TO EXPOSE THE WORKING CHANNEL SLEEVE. THE WORKING CHANNEL SLEEVE FELL OUT OF THE CATHETER. THERE WAS SOME EVIDENCE OF ADHESION OF THE WORKING CHANNEL SLEEVE TO THE INSIDE OF THE CATHETER, AS SEEN BY THE WORKING CHANNEL SLEEVE BRAID IMPRINT THROUGHOUT THE PEBAX REGION. THE COMPLAINT WAS CONSISTENT WITH THE REPORTED EVENT OF WORKING CHANNEL SLEEVE PROTRUDING. BASED ON THE INVESTIGATION AND THE RECEIPT CONDITION/ FUNCTIONALITY, THE COMPLAINT INVESTIGATION CONCLUSION 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 BILE DUCT DURING A SPYGLASS PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE WORKING CHANNEL SLEEVE OF THE SPYSCOPE DS PROTRUDED. REPORTEDLY, NO PART OF THE DEVICE DETACHED. THE PROCEDURE WAS COMPLETED WITH A SECOND SPYSCOPE DIGITAL ACCESS & DELIVERY CATHETER. 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

    PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. 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 BILE DUCT DURING A SPYGLASS PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE WORKING CHANNEL SLEEVE OF THE SPYSCOPE DS PROTRUDED. REPORTEDLY, NO PART OF THE DEVICE DETACHED. THE PROCEDURE WAS COMPLETED WITH A SECOND SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER. 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
    121053 SPYSCOPE DS ACCESS & DELIVERY CATHETER CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN BOSTON SCIENTIFIC - SPENCER M00546600 20804261 08714729863236

    Patients

    Seq Age Sex Outcome Treatment
    1