BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPHINCTEROTOME

    MDR report key: 2072827 · Received April 29, 2011

    Report

    Report Number
    3005099803-2011-01469
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 15, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FDI
    PMA / PMN Number
    K930022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    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 SLIGHTLY BENT AND BROKEN. THE BROKEN ENDS OF THE CUTTING WIRE APPEARED BLACKENED/DISCOLORED. THE OUTER DIAMETER (OD) OF THE CUTTING WIRE WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION. BASED ON THE MEASURED LENGTHS OF THE EXPOSED SECTIONS OF THE BROKEN CUTTING WIRE STILL ATTACHED TO THE DEVICE, IT APPEARS THAT THE ENTIRE SECTION OF THE BROKEN CUTTING WIRE REMAINED ATTACHED TO THE DEVICE. IT CANNOT BE CONFIRMED WHETHER A FRAGMENT OF THE CUTTING WIRE DETACHED FROM THE DEVICE AND WAS RETRIEVED, AS REPORTED BY THE COMPLAINANT. THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE CUTTING WIRE BROKE; HOWEVER, IT WAS UNABLE TO BE CONFIRMED WHETHER A FRAGMENT OF THE CUTTING WIRE DETACHED FROM THE DEVICE. DURING MANUFACTURING, THE SPHINCTEROTOME DEVICES ARE 100% INSPECTED AND THE BROKEN CUTTING WIRE 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.

    Additional Manufacturer Narrative · 1

    INTERVENTION REQUIRED TO REMOVE WIRE FRAGMENT. 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL SPHINCTEROTOME WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE WHEN CURRENT WAS DELIVERED TO THE DEVICE TO PERFORM THE SPHINCTEROTOMY, THE CUTTING WIRE BROKE. A SECTION OF THE CUTTING WIRE DETACHED FROM THE DEVICE. THE WIRE FRAGMENT WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER ULTRATOME XL 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL SPHINCTEROTOME WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE WHEN CURRENT WAS DELIVERED TO THE DEVICE TO PERFORM THE SPHINCTEROTOMY, THE CUTTING WIRE BROKE. A SECTION OF THE CUTTING WIRE DETACHED FROM THE DEVICE. THE WIRE FRAGMENT WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER ULTRATOME XL 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 SPHINCTEROTOME SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - SPENCER M00535920 13654826

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention