BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPHINCTEROTOME

    MDR report key: 2083580 · Received May 10, 2011

    Report

    Report Number
    3005099803-2011-01609
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FDI
    PMA / PMN Number
    K930022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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 EXPOSED CUTTING WIRE WAS BENT AND BROKEN. THE DISTAL END OF THE BROKEN CUTTING WIRE WAS SECURELY ATTACHED TO THE ANCHOR AND WAS NOTED TO BE BENT AND MISSHAPEN. THE BROKEN ENDS OF THE CUTTING WIRE APPEARED BLACKENED/DISCOLORED INDICATING ELECTRICAL ACTIVATION OF THE DEVICE. THE OUTER DIAMETER (OD) OF THE EXPOSED CUTTING WIRE WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION. 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 ANY DEFECT IS SCRAPPED AND DOCUMENTED IN THE DEVICE HISTORY RECORD (DHR). A REVIEW OF THE DHR CONFIRMED THAT THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS. THEREFORE, THE BENT AND BROKEN CUTTING WIRE IS LIKELY DUE TO PROCEDURAL/ANATOMICAL FACTORS AND THE MOST PROBABLE ROOT CAUSE IS "OPERATIONAL CONTEXT." A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED BATCH.

    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, THE DEVICE WAS ADVANCED DOWN THE ENDOSCOPE AND POSITIONED WITHIN THE DUODENUM. HOWEVER, WHEN THE DEVICE WAS BOWED, THE CUTTING WIRE BROKE AT THE DISTAL END. NO PORTION OF THE CUTTING WIRE DETACHED FROM THE DEVICE INSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH 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 FINE.

    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, THE DEVICE WAS ADVANCED DOWN THE ENDOSCOPE AND POSITIONED WITHIN THE DUODENUM. HOWEVER, WHEN THE DEVICE WAS BOWED, THE CUTTING WIRE BROKE AT THE DISTAL END. NO PORTION OF THE CUTTING WIRE DETACHED FROM THE DEVICE INSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPHINCTEROTOME SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - SPENCER M00535920 13981175

    Patients

    Seq Age Sex Outcome Treatment
    1