BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMTOME¿ RX 44

    MDR report key: 2931395 · Received January 28, 2013

    Report

    Report Number
    3005099803-2013-00155
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    November 29, 2012
    Report Date
    January 8, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE WORKING LENGTH/DISTAL TIP OF THE DEVICE WAS TWISTED, AND THE GUIDEWIRE LUMEN WAS RIPPED FROM THE WIDE BROWN PAINT BAND TO THE DISTAL TIP, TEARING THE DISTAL TIP. THE EXPOSED CUTTING WIRE WAS DISCOLORED AND APPEARED TO HAVE MELTED/SPLIT THE EXTRUSION AT THE DISTAL PIERCE HOLE. THE MELT/SPLIT ELONGATED THE DISTAL PIERCE HOLE TO APPROXIMATELY 7MM. THIS TEAR CAUSED THE CUT WIRE ANCHOR TO SLIDE PROXIMALLY FROM THE DISTAL PIERCE HOLE, SHORTENING THE LENGTH OF THE EXPOSED CUT WIRE, WHICH NO LONGER MEETS SPECIFICATION. A FUNCTIONAL EVALUATION FOUND THAT THE DEVICE WOULD NOT BOW SUFFICIENTLY TO MEET SPECIFICATION DUE TO THE MELTED EXTRUSION AND ALTERED EXPOSED CUTTING WIRE LENGTH. REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT WAS OPERATIONAL CONTEXT, LIKELY DUE TO PROCEDURAL FACTORS/GENERATOR SETTINGS. 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 DREAMTOME WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TOME WOULD NOT BOW. THE PROCEDURE WAS COMPLETED WITH ANOTHER DREAMTOME. 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 "OK". THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING: CATHETER TORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37597 DREAMTOME¿ RX 44 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00584040 15522159

    Patients

    Seq Age Sex Outcome Treatment
    1