BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME? RX 49

    MDR report key: 3221024 · Received July 11, 2013

    Report

    Report Number
    3005099803-2013-06034
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    May 2, 2013
    Report Date
    June 23, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ZA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE EVENT: CATHETER TORN. VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE EXPOSED CUTTING WIRE WAS KINKED, THE WORKING LENGTH WAS TWISTED, AND THE RX CHANNEL WAS TORN OPEN WITH IRREGULAR SHAPE AND ROUGH SURFACE FROM THE BROWN PAINT MARKER TO THE TIP. THE EXPOSED CUTTING WIRE LENGTH WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION. THE TORN SECTION OF THE RX CHANNEL WAS MEASURED AND FOUND TO BE 60 MM; THIS INDICATES THAT THE RX CHANNEL CLOSED LENGTH MET SPECIFICATION PRIOR TO BEING TORN. FUNCTIONAL EVALUATION WAS PERFORMED BY INTRODUCING A SAMPLE 0.035 IN GUIDEWIRE BY THE GUIDEWIRE INTRODUCER; IT WAS FOUND THAT THIS GUIDEWIRE COULD BE ADVANCED THROUGH THE C-CHANNEL WITHOUT ISSUES. REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT WAS OPERATIONAL CONTEXT, SINCE PROCEDURAL OR ANATOMICAL FACTORS COULD HAVE CAUSED THE FAILURES FOUND/REPORTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT. THE DEVICE HISTORY RECORD REVIEW FOUND THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, AFTER THE ERCP WAS PERFORMED WITH THIS DEVICE, WHEN THE GUIDEWIRE WAS REMOVED, THE HYDRATOME WAS UNINTENTIONALLY REMOVED AS WELL SINCE THE GUIDEWIRE SEEMED 'STUCK' IN THE TOME. WHEN THE DEVICE WAS INSPECTED AFTER REMOVAL, THE DISTAL TIP OF THE TOME APPEARED 'SPLICED'. THE PROCEDURE WAS COMPLETED USING THIS DEVICE. 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 REPORTABLE BASED ON THE INVESTIGATION FINDING: CATHETER TORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320545 HYDRATOME? RX 49 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00583020 0015563779

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR