BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYSCOPE DS ACCESS & DELIVERY CATHETER

    MDR report key: 6561981 · Received May 11, 2017

    Report

    Report Number
    3005099803-2017-01309
    Event Type
    Malfunction
    Date Received
    May 11, 2017
    Date of Event
    November 18, 2016
    Report Date
    April 20, 2017
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FBN
    UDI-DI
    08714729863236
    PMA / PMN Number
    K142922
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE SPYSCOPE DS DEVICE FOUND THE WORKING CHANNEL SLEEVE EXTENDED FROM THE DISTAL CAP WHEN RECEIVED. MOREOVER, THE CATHETER WAS FOUND KINKED. 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 COMPLAINT WAS NOT CONSISTENT WITH THE REPORTED EVENT OF LOSS OF VISUALIZATION. IN ADDITION, THE WORKING CHANNEL SLEEVE EXTENDED FROM THE DISTAL CAP WHEN RECEIVED. BASED ON THE INVESTIGATION AND THE RECEIPT CONDITION/FUNCTIONALITY, THE MOST PROBABLE ROOT CAUSE IS "MANUFACTURING". AN INVESTIGATION ADDRESSING THIS ISSUE HAS BEEN COMPLETED. 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 DS ACCESS & DELIVERY CATHETER WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, AT THE END OF THE PROCEDURE, THE SPYSCOPE DS IMAGE WAS LOST INTERMITTENTLY. REPORTEDLY, THERE WERE NO VISIBLE DAMAGE WITH THE DEVICE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE 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 STABLE. 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
    343230 SPYSCOPE DS ACCESS & DELIVERY CATHETER CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN BOSTON SCIENTIFIC - SPENCER M00546600 19213092 08714729863236

    Patients

    Seq Age Sex Outcome Treatment
    1