BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYSCOPE DS ACCESS & DELIVERY CATHETER

    MDR report key: 6533344 · Received May 1, 2017

    Report

    Report Number
    3005099803-2017-01199
    Event Type
    Malfunction
    Date Received
    May 1, 2017
    Date of Event
    March 13, 2017
    Report Date
    April 3, 2017
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FBN
    UDI-DI
    08714729863236
    PMA / PMN Number
    K142922
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE SPYSCOPE DS DEVICE FOUND THAT THE CATHETER WAS KINKED IN MULTIPLE LOCATIONS. THE WORKING CHANNEL SLEEVE EXTENDED FROM THE DISTAL CAP WHEN RECEIVED. THE SPYSCOPE DS WAS PLUGGED INTO THE CONTROLLER; IT DID INITIALIZE AND DISPLAY A LIVE IMAGE WITHOUT ISSUE. THE DISTAL TIP WOULD ARTICULATE WITHOUT ISSUE AND WAS NOT LOOSE. THE PROXIMAL END OF THE DISTAL CAP WAS ALIGNED TO THE CAP WELD. A SPYBITE DEVICE WAS PASSED THROUGH THE WORKING CHANNEL WITHOUT ISSUE. THE DISTAL END OF THE EXPOSED WORKING CHANNEL SLEEVE WAS TUGGED; IT WAS NOT DETACHED FROM THE CATHETER. THERE WAS EVIDENCE THAT HEAT WAS APPLIED ON THE OUTSIDE OF THE CATHETER DURING MANUFACTURING ASSEMBLY. PART OF THE DISTAL END OF THE CATHETER WAS REMOVED TO EXAMINE THE WORKING CHANNEL. FURTHER EVALUATION FOUND THAT THERE IS EVIDENCE OF ADHESION OF THE WORKING CHANNEL SLEEVE TO THE INSIDE OF THE CATHETER. THE WORKING CHANNEL SLEEVE PROTRUSION COULD HAVE BEEN GENERATED BY SOME OPERATIONAL ASPECT OF THE PROCEDURE. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THE COMPLAINT IS OPERATIONAL CONTEXT. A DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND.

    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 BILIARY DUCT DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH SPYGLASS PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SPYSCOPE DS IMAGE WAS LOST. REPORTEDLY, THERE WERE NO VISIBLE DAMAGE WITH THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A SECOND SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER AND THE SAME SPYGLASS DS CONTROLLER. 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 "FINE". THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; WORKING CHANNEL SLEEVE PROTRUSION. PLEASE SEE BLOCK FOR FULL INVESTIGATION DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316568 SPYSCOPE DS ACCESS & DELIVERY CATHETER CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN BOSTON SCIENTIFIC - SPENCER M00546600 20128089 08714729863236

    Patients

    Seq Age Sex Outcome Treatment
    1