BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYSCOPE DS ACCESS & DELIVERY CATHETER

    MDR report key: 6572454 · Received May 17, 2017

    Report

    Report Number
    3005099803-2017-01501
    Event Type
    Malfunction
    Date Received
    May 17, 2017
    Date of Event
    March 22, 2017
    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 Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT OF TIP DETACHED. A VISUAL EXAMINATION FOUND THAT THE CATHETER WAS KINKED IN MULTIPLE LOCATIONS. A FRAGMENT OF THE DISTAL CAP WAS DETACHED FROM THE DEVICE AND PROCEDURAL FLUIDS WERE SEEN PROTRUDING FROM THE WORKING CHANNEL. A FUNCTIONAL INSPECTION WAS PERFORMED. THE SPYSCOPE DS WAS PLUGGED INTO THE CONTROLLER; THERE WERE NO ISSUES WITH THE LIVE IMAGE AND NO LIGHT LEAKAGE WAS NOTED ALONG THE DEVICE CATHETER. THE DEVICE WAS LAID OUT STRAIGHT AND FULLY ARTICULATED IN MANY DIRECTIONS. NO ISSUES WERE IDENTIFIED WITH THE IMAGE. A SPYBITE WAS PASSED THROUGH THE WORKING CHANNEL, AND NO ISSUES WERE IDENTIFIED WITH THE IMAGE. THE DISTAL END OF THE CATHETER WAS SUBMERGED IN WATER WHILE THE SPYBITE WAS PASSED AND THE TIP WAS ARTICULATED, NO ISSUES WITH THE IMAGE WERE FOUND. USING A SYRINGE, WATER WAS PULLED INTO THE WORKING CHANNEL AND THE DISTAL TIP WAS LEFT SUBMERGED INTO THE WATER. NO ISSUES WERE IDENTIFIED WITH THE IMAGE. THE HANDLE WAS DISASSEMBLED FOR EXAMINATION AND NO ISSUES WERE IDENTIFIED . THE IMAGE ISSUE WAS NOT ABLE TO BE RECREATED DURING THE ANALYSIS OF THE DEVICE. THE COMPLAINT WAS NOT CONSISTENT WITH THE REPORTED EVENT OF POOR IMAGE QUALITY AND LOSS OF VISUALIZATION, HOWEVER, A FRAGMENT OF THE DISTAL TIP WAS DETACHED. THE INVESTIGATION CONCLUDED THAT IT IS LIKELY THAT THE PHYSICIAN APPLIED EXCESSIVE FORCE WITH AN ACCESSORY/TECHNIQUE THAT CAUSED THE FRAGMENT OF THE DISTAL CAP TO DETACH. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THE DETACHED TIP IS OPERATIONAL CONTEXT. A DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED AND THERE WERE NO NON-CONFORMING EVENTS OR DEVIATIONS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE LIGHT WAS LEAKING IN SOME PARTS OF THE SPYSCOPE DS. ADDITIONALLY, THE SPYSCOPE DS IMAGE GOT DISTORTED AND LOST. REPORTEDLY, THERE WAS NO OTHER VISIBLE DAMAGE NOTED ON THE SPYSCOPE DS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; A FRAGMENT OF THE DISTAL TIP DETACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353681 SPYSCOPE DS ACCESS & DELIVERY CATHETER CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN BOSTON SCIENTIFIC - SPENCER M00546600 19981136 08714729863236

    Patients

    Seq Age Sex Outcome Treatment
    1