BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYSCOPE DS ACCESS & DELIVERY CATHETER

    MDR report key: 7557209 · Received May 31, 2018

    Report

    Report Number
    3005099803-2018-01713
    Event Type
    Malfunction
    Date Received
    May 31, 2018
    Date of Event
    April 17, 2018
    Report Date
    May 15, 2018
    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

    ALTHOUGH THE PATIENT'S AGE IS UNKNOWN, IT WAS REPORTED THAT THE PATIENT IS OVER THE AGE OF 18. A VISUAL EXAMINATION WAS PERFORMED AFTER DISINFECTION AND FOUND THAT THE WORKING CHANNEL SLEEVE (WCS) DID NOT PROTRUDE; HOWEVER, THE MAXIMUM WCS PROTRUSION WAS NOTED WHEN THE TIP WAS ARTICULATED BY TURNING THE LARGE KNOB IN THE CLOCKWISE DIRECTION. A FUNCTIONAL EVALUATION WAS PERFORMED. THE DEVICE WAS PLUGGED INTO THE CONTROLLER. NO IMAGE WAS DISPLAYED, CONFIRMING LOST IMAGE. THE DISTAL TIP WAS CUT AND THE DISTAL CAP WAS REMOVED. THE CATHETER WAS CUT OPEN USING THE CUTTING FIXTURE. WITNESS MARKS WERE NOTED ON THE PEBAX. THE WHITE AND CLEAR AREAS ALONG BOND A, AS WELL AS THE PROXIMAL SECTION OF THE WCS BRAID REMAINING ATTACHED TO THE PEBAX, APPEAR TO SHOW EVIDENCE OF ADHESION. THE RETURNED DEVICE WAS ANALYZED AS "WORKING CHANNEL SLEEVE PROTRUDING.". BASED ON THE INVESTIGATION RESULTS, THE UNDERLYING CAUSE OF WORKING CHANNEL SLEEVE PROTRUSION IS AN INSUFFICIENT BOND, PARTICULARLY THE SECOND HEAT CYCLE OF THE WORKING CHANNEL SLEEVE BONDING PROCESS [BOND B]. THEREFORE, THE COMPLAINT INVESTIGATION CONCLUSION CODE SELECTED FOR THE WORKING CHANNEL SLEEVE PROTRUSION ISSUE IS MANUFACTURING PROCESS DESIGN. AN INVESTIGATION IS UNDERWAY TO ADDRESS THIS ISSUE. A DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND NO DEVIATION WAS FOUND. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS ACCESS & DELIVERY CATHETER WAS USED DURING A PER-ORAL CHOLANGIOSCOPY (POCS) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SPYSCOPE DS WORKED UPON INSERTION INTO THE BILE DUCT; HOWEVER, WHEN THE DEVICE WAS REMOVED AND INSERTED INTO THE BILE DUCT FOR A SECOND TIME, THE SCREEN BECAME DISTORTED AND GREY DOTS APPEARED ON THE SCREEN BEFORE THE IMAGE WAS LOST COMPLETELY. THE PROCEDURE WAS COMPLETED WITH ANOTHER 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; WORKING CHANNEL SLEEVE PROTRUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398961 SPYSCOPE DS ACCESS & DELIVERY CATHETER CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN BOSTON SCIENTIFIC - SPENCER M00546600 21895426 08714729863236

    Patients

    Seq Age Sex Outcome Treatment
    1