BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME? RX 44

    MDR report key: 3212663 · Received July 9, 2013

    Report

    Report Number
    3005099803-2013-05844
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 13, 2013
    Report Date
    June 18, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S AGE IS UNKNOWN; HOWEVER THE PATIENT WAS OVER 18 YEARS OF AGE. (B)(4) FOR THE EVENT: CATHETER TORN. VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE WORKING LENGTH AND DISTAL TIP OF THE DEVICE WERE TWISTED AND THE RX CHANNEL WAS EXTENDED AND TORN. THE EXPOSED CUTTING WIRE LENGTH WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATIONS. FUNCTIONAL EVALUATION FOUND THAT WHEN THE DISTAL TIP EMERGED FROM THE SCOPE, THE ORIENTATION OF THE TIP WAS AT 1 O'CLOCK DUE TO THE TWISTED TIP. AFTER THE HANDLE WAS ROTATED TO UNTWIST THE TIP, IT WAS FOUND THAT THE TIP ORIENTATION WAS AT 9 O'CLOCK, WITHIN SPECIFICATIONS. IN ADDITION, THE TIP BOWED PROPERLY. REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT WAS OPERATIONAL CONTEXT, SINCE ANATOMICAL/PROCEDURAL FACTORS LIKELY LIMITED PERFORMANCE OF THE DEVICE. 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, DURING THE PROCEDURE, THE ORIENTATION OF THE TIP OF THE DEVICE WAS INCORRECT WHEN IT EMERGED FROM THE SCOPE ("MORE LIKE OF 8 O'CLOCK WHERE IT WAS SUPPOSED TO BE IN AN 11 O'CLOCK POSITION"). THE DEVICE WAS THEN REMOVED FROM THE PATIENT, AND WHILE PERFORMING THE DEVICE EXCHANGE, THE CATHETER (RX CHANNEL) WAS INADVERTENTLY TORN THROUGH THE TIP OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER HYDRATOME. 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312305 HYDRATOME? RX 44 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00583040 0015766087

    Patients

    Seq Age Sex Outcome Treatment
    1