BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELON?

    MDR report key: 3790336 · Received May 5, 2014

    Report

    Report Number
    3005099803-2014-01827
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Report Date
    April 13, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    EOQ
    PMA / PMN Number
    K040018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: NEEDLE PUNCTURED THROUGH THE SHEATH. VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THE NEEDLE HAD PENETRATED THROUGH THE OUTER EXTRUSION AT THE PROXIMAL END OF THE DISTAL STOP. WHILE THE NEEDLE WAS PROTRUDING THROUGH THE SHEATH, THE HANDLE WAS ACTUATED AND THE NEEDLE WOULD EXTEND AND RETRACT WITHOUT ISSUE. WHEN THE NEEDLE WAS RETRACTED, THE TIP OF THE NEEDLE WAS STILL EXTENDING OUT OF THE OUTER SHEATH. THE INVESTIGATION CONCLUDED THAT THIS COMPLAINT IS ASSOCIATED WITH A PRODUCT THAT MEETS DESIGN AND MANUFACTURE SPECIFICATIONS BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE OF THE DEVICE WAS LIMITED. THE DEVICE WAS LIKELY BENT AT THE PROXIMAL END OF THE DISTAL STOP WHILE IT WAS BEING MANEUVERED DURING THE PROCEDURE. SUBSEQUENTLY, WHEN NEEDLE WAS EXTENDED WITH THE SHEATH BENT, THE NEEDLE PUNCTURED THE OUTER SHEATH. THEREFORE, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION FOR THE ENCOUNTERED FAILURE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXCELON TBAN NEEDLE WAS USED. ACCORDING TO THE COMPLAINANT, THE DEVICE WOULD NOT ADVANCE OUT OF THE SHEATH. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION RESULTS: NEEDLE PUNCTURED THROUGH THE SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266957 EXCELON? BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BOSTON SCIENTIFIC - SPENCER M00564111 16287642

    Patients

    Seq Age Sex Outcome Treatment
    1