BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOTOME RX SPHINCTEROTOME

    MDR report key: 2040207 · Received April 5, 2011

    Report

    Report Number
    3005099803-2011-01088
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 16, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE WORKING LENGTH WAS TWISTED AND BEN. THE EXPOSED CUT WIRE WAS BENT, BROKEN AND THE BROKEN ENDS OF THE CUTTING WIRE APPEARED BURNT/BLACKENED. 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 WAS ATTACHED TO THE ANCHOR AT THE DISTAL PIERCE HOLE. THE OUTER DIAMETER (OD) OF THE EXPOSED CUT WIRE WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION. DURING MANUFACTURING, TOME DEVICES ARE 100% INSPECTED SO THE BROKEN CUT WIRE IS LIKELY DUE TO PROCEDURAL FACTORS. THEREFORE, THE MOST PROBABLE ROOT CAUSE 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

    NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT # 3005099803-2011-01087 AND MFR. REPORT # 3005099803-2011-01088). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO AUTOTOME RX SPHINCTEROTOMES WERE USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE'S CUT WIRE BROKE. A SECOND AUTOTOME RX SPHINCTEROTOME WAS THEN OBTAINED AND THE DEVICE'S CUT WIRE BROKE. NO PART OF THE CUT WIRE FROM EITHER DEVICE FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A THIRD AUTOTOME 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 IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT # 3005099803-2011-01087 AND MFR. REPORT # 3005099803-2011-01088). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO AUTOTOME RX SPHINCTEROTOMES WERE USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE'S CUT WIRE BROKE. A SECOND AUTOTOME RX SPHINCTEROTOME WAS THEN OBTAINED AND THE DEVICE'S CUT WIRE BROKE. NO PART OF THE CUT WIRE FROM EITHER DEVICE FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A THIRD AUTOTOME 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 AUTOTOME RX SPHINCTEROTOME UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - SPENCER M00545170 13993284

    Patients

    Seq Age Sex Outcome Treatment
    1