BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SPHINCTEROTOME

    MDR report key: 1933414 · Received December 20, 2010

    Report

    Report Number
    3005099803-2010-05087
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    October 15, 2010
    Report Date
    November 30, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE WORKING LENGTH WAS TWISTED AND THE EXPOSED CUT WIRE WAS BENT/MISALIGNED. FUNCTIONAL TESTING FOUND WHEN THE DEVICE WAS ADVANCED DOWN THE SCOPE, THE DEVICE'S INITIAL TIP ORIENTATION WAS NOT WITHIN SPECIFICATION DUE TO THE BENT/MISALIGNED CUT WIRE AND TWISTED WORKING LENGTH. FURTHERMORE, THE TOME TIP MET THE MINIMUM BOWING SPECIFICATION, HOWEVER DUE TO THE BENT CUT WIRE THE DEVICE FAILED TO BOW IN PLANE. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT THAT THE CUT WIRE WAS TWISTED. HOWEVER, THE EVALUATION FOUND THAT THE WORKING LENGTH WAS TWISTED AND THE EXPOSED CUT WIRE WAS BENT/MISALIGNED. DURING MANUFACTURING, TOME DEVICE'S ARE 100% INSPECTED FOR WORKING LENGTH/CUT WIRE INTEGRITY SO THE DAMAGE LIKELY OCCURRED DUE TO PROCEDURAL FACTORS. THEREFORE, THE MOST PROBABLE ROOT IS OPERATIONAL CONTEXT. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR 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 RX SPHINCTEROTOME WAS USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE HYDRATOME RX SPHINCTEROTOME WAS ADVANCED DOWN THE OLYMPUS THERAPEUTIC DUODENOSCOPE. THE PHYSICIAN CANNULATED THE PAPILLA WITH THE SPHINCTEROTOME. THE PHYSICIAN ATTEMPTED TO POSITION THE DEVICE TO PERFORM THE SPHINCTEROTOMY, HOWEVER, IT WAS NOTED THAT THE CUTTING WIRE WAS TWISTED AROUND THE CATHETER. THE PHYSICIAN ATTEMPTED TO ROTATE THE DEVICE TO STRAIGHTEN THE WIRE BUT WAS UNSUCCESSFUL. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER HYDRATOME RX SPHINCTEROTOME. 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; CUT WIRE BENT/MISALIGNED AND NOT BOWING IN PLANE.

    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 M00583040 13701354

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR