BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYSCOPE DS ACCESS & DELIVERY CATHETER

    MDR report key: 7181449 · Received January 10, 2018

    Report

    Report Number
    3005099803-2017-03965
    Event Type
    Malfunction
    Date Received
    January 10, 2018
    Date of Event
    December 13, 2017
    Report Date
    December 13, 2017
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FBN
    UDI-DI
    08714729863236
    PMA / PMN Number
    K142922
    Removal / Correction Number
    1828132-12/22/2017-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SG
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: A VISUAL ASSESSMENT WAS PERFORMED AFTER DISINFECTION. THE WORKING CHANNEL SLEEVE EXTENDED FROM THE DISTAL CAP WHEN RECEIVED, CONFIRMING THE COMPLAINT. THE TIPS OF THE PROTRUDING SLEEVE WERE FRAYED. 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 EVALUATION WAS PERFORMED. THE DISTAL TIP ARTICULATED WITHOUT ISSUE. A SPYBITE DEVICE WAS PASSED THROUGH THE WORKING CHANNEL WITHOUT ISSUE. 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 TO EXPOSE THE WORKING CHANNEL SLEEVE. THE CATHETER WAS PULLED BACK TO ASSESS THE ADHESION OF THE WORKING CHANNEL SLEEVE TO THE PEBAX; THE PROXIMAL END OF THE WORKING CHANNEL SLEEVE APPEARED TO BE ATTACHED TO THE PEBAX (BONDED LENGTH). THE WORKING CHANNEL SLEEVE DID NOT FALL OUT; THE WORKING CHANNEL SLEEVE WAS PULLED OUT OF THE CATHETER. THERE WAS EVIDENCE OF ADHESION OF THE WORKING CHANNEL SLEEVE TO THE INSIDE OF THE CATHETER, AS SEEN BY THE WHITE AREA ON THE PROXIMAL END OF THE PEBAX AND THE WORKING CHANNEL 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 CONCLUSION INVESTIGATION 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.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF THE TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2017-03964 FOR THE FIRST SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER AND 3005099803-2017-03965 FOR THE SECOND SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER. 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) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN WAS EXAMINING THE COMMON BILE DUCT (CBD) AND IT WAS NOTICED ON THE MONITOR THAT THE WORKING CHANNEL SLEEVE OF THE SPYSCOPE DS WAS PROTRUDING. A SECOND SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER WAS USED AND THE SAME THING HAPPENED. REPORTEDLY, NO PART OF THE DEVICE DETACHED. THE PROCEDURE WAS COMPLETED DUE TO ANOTHER REASON. 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 B "STABLE".

    Description of Event or Problem · 1

    THIS REPORT PERTAINS TO ONE OF THE TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2017-03964 FOR THE FIRST SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER AND 3005099803-2017-03965 FOR THE SECOND SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETERWAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN WAS EXAMINING THE COMMON BILE DUCT (CBD) AND IT WAS NOTICED ON THE MONITOR THAT THE WORKING CHANNEL SLEEVE OF THE SPYSCOPE DS WAS PROTRUDING. A SECOND SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER WAS USED AND THE SAME THING HAPPENED. REPORTEDLY, NO PART OF THE DEVICE DETACHED. THE PROCEDURE WAS COMPLETED DUE TO ANOTHER REASON. 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 B "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24583 SPYSCOPE DS ACCESS & DELIVERY CATHETER CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN BOSTON SCIENTIFIC - SPENCER M00546600 21269880 08714729863236

    Patients

    Seq Age Sex Outcome Treatment
    1