BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYSCOPE DS ACCESS & DELIVERY CATHETER

    MDR report key: 6510634 · Received April 21, 2017

    Report

    Report Number
    3005099803-2017-01142
    Event Type
    Malfunction
    Date Received
    April 21, 2017
    Date of Event
    March 6, 2017
    Report Date
    March 28, 2017
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FBN
    PMA / PMN Number
    K142922
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A VISUAL EXAMINATION OF THE SPYSCOPE DS DEVICE FOUND THE WORKING CHANNEL SLEEVE EXTENDED FROM THE DISTAL CAP WHEN RECEIVED. MOREOVER, THE CATHETER WAS KINKED IN MULTIPLE LOCATIONS. WHEN THE DEVICE WAS PLUGGED INTO THE CONTROLLER, THE IMAGE THAT DISPLAYED WAS OF POOR QUALITY AND VISUALIZATION WAS THEN LOST. THE DISTAL TIP WOULD ARTICULATE WITHOUT ISSUE. THE PROXIMAL END OF THE DISTAL CAP WAS ALIGNED TO THE CAP WELD. A SPYBITE DEVICE WAS PASSED THROUGH THE WORKING CHANNEL; RESISTANCE WAS FELT IN THE KINKED SECTION OF THE CATHETER. 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 COMPLAINT WAS CONSISTENT WITH THE REPORTED EVENT OF POOR IMAGE QUALITY. IN ADDITION, THE WORKING CHANNEL SLEEVE EXTENDED FROM THE DISTAL CAP WHEN RECEIVED. MOST LIKELY, THE WORKING CHANNEL SLEEVE PROTRUSION WAS DUE TO SOME OPERATIONAL OR ANATOMICAL 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. A SEARCH OF THE COMPLAINT DATABASE CONFIRMED THAT NO OTHER 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 BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH CHOLANGIOSCOPY PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING 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 END 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293587 SPYSCOPE DS ACCESS & DELIVERY CATHETER CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN BOSTON SCIENTIFIC - SPENCER M00546600 20129956

    Patients

    Seq Age Sex Outcome Treatment
    1