BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOTOME RX SPHINCTEROTOME

    MDR report key: 2071049 · Received April 27, 2011

    Report

    Report Number
    3005099803-2011-01374
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 7, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    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 CUTTING WIRE WAS BENT AND BROKEN. IN ADDITION, THE EXTRUSION WAS RIPPED OPEN ALONG THE LENGTH OF THE DISTAL TIP, SPLITTING THE TIP. THE CUTTING WIRE WAS DISCOLORED FROM USE AND THE BROKEN ENDS APPEARED BURNT/BLACKENED. THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE CUTTING WIRE BROKE. DURING MANUFACTURING, THE SPHINCTEROTOME DEVICES ARE 100% INSPECTED AND THE BROKEN CUTTING WIRE AND SPLIT EXTRUSION ARE 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.

    Additional Manufacturer Narrative · 1

    (B)(4) RELATES TO (B)(4) FOR THE REPORTED EVENT OF WIRE BROKE. 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.

    Description of Event or Problem · 1

    NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT # 3005099803-2011-01372). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO AUTOTOME RX SPHINCTEROTOMES WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CUTTING WIRE BROKE ON THE FIRST DEVICE DURING USE. NO PORTION OF THE CUTTING WIRE DETACHED FROM THE DEVICE INSIDE OF THE PATIENT. THE DEVICE WAS EXCHANGED FOR A SECOND AUTOTOME RX SPHINCTEROTOME. HOWEVER, THE CUTTING WIRE BROKE ON THE SECOND DEVICE. NO PORTION OF THE CUTTING WIRE DETACHED FROM THE DEVICE INSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED USING 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 STABLE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT # 3005099803-2011-01372 AND MFR. REPORT # 3005099803-2011-01374). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO AUTOTOME RX SPHINCTEROTOMES WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CUTTING WIRE BROKE ON THE FIRST DEVICE DURING USE. NO PORTION OF THE CUTTING WIRE DETACHED FROM THE DEVICE INSIDE OF THE PATIENT. THE DEVICE WAS EXCHANGED FOR A SECOND AUTOTOME RX SPHINCTEROTOME. HOWEVER, THE CUTTING WIRE BROKE ON THE SECOND DEVICE. NO PORTION OF THE CUTTING WIRE DETACHED FROM THE DEVICE INSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED USING 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 STABLE.

    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 M00545150 13761404

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR