BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMTOME RX SPHINCTEROTOME

    MDR report key: 1852307 · Received October 4, 2010

    Report

    Report Number
    3005099803-2010-04124
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 13, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, AND / OR IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION REVEALED THAT THE WORKING LENGTH WAS TWISTED AND THE EXPOSED CUT WIRE WAS BENT AND BROKEN. THE BROKEN SECTION OF THE EXPOSED CUTTING WIRE HAD RETRACTED INSIDE THE LUMEN OF THE EXTRUSION THROUGH THE PROXIMAL PIERCE HOLE AND THE OTHER BROKEN SECTION OF THE EXPOSED CUT WIRE REMAINED ATTACHED TO THE DEVICE AT THE DISTAL PIERCE HOLE. DURING ANALYSIS, THE RETRACTED CUTTING WIRE WAS PUSHED OUT OF THE EXTRUSION THROUGH THE PROXIMAL PIERCE HOLE. THE BROKEN CUTTING WIRE APPEARED BURNT/BLACKENED. THE OD OF THE EXPOSED CUT WIRE WAS MEASURED AND MEETS THE OD SPECIFICATION. THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE CUT WIRE BROKE/SNAPPED. DURING MANUFACTURING, TOME DEVICES ARE 100% INSPECTED FOR CUT WIRE INTEGRITY AND BOWING/ HANDLE FUNCTIONALITY SO THE WIRE BREAK LIKELY OCCURRED DUE TO PROCEDURAL FACTORS. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMS THAT THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. THE TWO DEVICES HAVE BEEN REPORTED IN MFR. REPORT # 3005099803-2010-04124, AND # 3005099803-2010-04125. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX SPHINCTEROTOME WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE SPHINCTEROTOMY, THE CUTTING WIRE SNAPPED WITHIN THE COMMON BILE DUCT. THE WIRE BROKE IN HALF BUT REMAINED AFFIXED TO THE CATHETER AT BOTH ENDS. NO PART OF THE CUTTING WIRE FELL INTO THE PATIENT. THIS SAME ISSUE WAS ENCOUNTERED WITH A TOTAL OF TWO DREAMTOME RX SPHINCTEROTOMES DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A THIRD DREAMTOME 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.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. THE TWO DEVICES HAVE BEEN REPORTED IN MFR. REPORT # 3005099803-2010-04124, AND # 3005099803-2010-04125. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX SPHINCTEROTOME WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE SPHINCTEROTOMY, THE CUTTING WIRE SNAPPED WITHIN THE COMMON BILE DUCT. THE WIRE BROKE IN HALF BUT REMAINED AFFIXED TO THE CATHETER AT BOTH ENDS. NO PART OF THE CUTTING WIRE FELL INTO THE PATIENT. THIS SAME ISSUE WAS ENCOUNTERED WITH A TOTAL OF TWO DREAMTOME RX SPHINCTEROTOMES DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A THIRD DREAMTOME 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DREAMTOME RX SPHINCTEROTOME UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - SPENCER M00584040 0013594152

    Patients

    Seq Age Sex Outcome Treatment
    1