BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME? RX 44

    MDR report key: 3132821 · Received May 29, 2013

    Report

    Report Number
    3005099803-2013-04018
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    March 12, 2013
    Report Date
    May 8, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S AGE IS UNKNOWN; HOWEVER, THE PATIENT WAS OVER 18 YEARS OF AGE. INVESTIGATION FINDING: CATHETER TORN. VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE CUTTING WIRE WAS BROKEN, THE DISTAL SECTION OF THE CATHETER WAS TORN, AND THERE WAS A TWIST IN THE WORKING LENGTH. THE CUTTING WIRE LENGTH WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATIONS. EXAMINATION OF THE BROKEN CUTTING WIRE REVEALED THAT BENDING, TENSION, AND MELTING CONTRIBUTED TO THE BREAK. REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT WAS OPERATIONAL CONTEXT, SINCE PROCEDURAL OR ANATOMICAL FACTORS ENCOUNTERED DURING THE PROCEDURE COULD HAVE AFFECTED DEVICE INTEGRITY AND PERFORMANCE. 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, WHEN SPHINCTEROTOMY WAS BEING PERFORMED WITH THE DEVICE, THE CUT WIRE BROKE. HOWEVER, BY THE TIME THE CUT WIRE OF THIS DEVICE BROKE, THE SPHINCTEROTOMY WAS COMPLETE; THE PROCEDURE WAS COMPLETED WITH 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 FINE. THE CUT WIRE BREAK WAS REPORTED BY ALTERNATIVE SUMMARY REPORTING (ASR) ON (B)(6) 2013. THIS EVENT HAS BEEN DEEMED 30-DAY REPORTABLE BASED ON THE INVESTIGATION FINDING: CATHETER TORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237368 HYDRATOME? RX 44 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - SPENCER M00583050 0015679073

    Patients

    Seq Age Sex Outcome Treatment
    1