BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SPHINCTEROTOME

    MDR report key: 2141674 · Received June 27, 2011

    Report

    Report Number
    3005099803-2011-02041
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    April 19, 2011
    Report Date
    June 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE EXACT PATIENT AGE IS UNKNOWN, THE PATIENT WAS REPORTED TO BE OVER 18 YEARS OF AGE. A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE WORKING LENGTH WAS TWISTED AND THE EXPOSED CUTTING WIRE WAS DISCOLORED AND APPEARED TO HAVE MELTED/SPLIT THE EXTRUSION AT THE DISTAL PIERCE HOLE. THE TEAR IN THE EXTRUSION CAUSED THE CUTTING WIRE ANCHOR TO SLIDE PROXIMALLY, THEREBY ALTERING THE EXPOSED CUTTING WIRE LENGTH TO BECOME SHORTER. A FUNCTIONAL EVALUATION FOUND THAT THE DEVICE DID NOT MEET THE MINIMUM BOWING SPECIFICATION DUE TO THE ALTERED EXPOSED CUTTING WIRE LENGTH. THE CONDITION OF THE RETURNED DEVICE IS CONSISTENT WITH THE COMPLAINT THAT THE DEVICE FAILED TO BOW. DURING MANUFACTURING, THE SPHINCTEROTOME DEVICES ARE 100% INSPECTED AND THE MELTED/SPLIT EXTRUSION IS LIKELY DUE TO PROCEDURAL/ANATOMICAL FACTORS. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED BATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX SPHINCTEROTOME WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE FOR THE TREATMENT OF GALLSTONES ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE FAILED TO BOW WHEN ATTEMPTING TO PERFORM THE SPHINCTEROTOMY. THE DEVICE WAS WITHDRAWN FROM THE PATIENT. OUTSIDE OF THE PATIENT, THE DEVICE AGAIN FAILED TO BOW. THE PROCEDURE WAS COMPLETED WITH ANOTHER HYDRATOME RX SPHINCTEROTOME. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. BASED UPON THE INVESTIGATION RESULTS, WHICH INDICATE THAT THE CUTTING WIRE APPEARS TO HAVE MELTED THE EXTRUSION OF THE CATHETER AT THE DISTAL PIERCE HOLE, THIS IS NOW CONSIDERED A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRATOME RX SPHINCTEROTOME UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - SPENCER M00583050 14106438

    Patients

    Seq Age Sex Outcome Treatment
    1