BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPHINCTEROTOME

    MDR report key: 2025400 · Received March 21, 2011

    Report

    Report Number
    3005099803-2011-00776
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Report Date
    March 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FDI
    PMA / PMN Number
    K930022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE IS UNKNOWN, HOWEVER, THE PATIENT IS OVER (B)(6). THE DATE OF EVENT IS UNKNOWN. 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 BENT/KINKED. THERE WAS NO DAMAGE PRESENT ON THE DEVICE'S POUCH. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE DEVICE BENT/KINKED. DURING MANUFACTURING, TOME DEVICES ARE 100% INSPECTED SO BENT/KIE WORKING LENGTH IS LIKELY DUE TO HANDLING DURING PREPARATION. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS HANDLING DAMAGE. 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL SPHINCTEROTOME WAS TO BE USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, A KINK WAS NOTED, WHEN REMOVING THE DEVICE FROM THE PACKAGE. THERE WAS NO DAMAGE TO THE PACKAGING. 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 TO BE USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, A KINK WAS NOTED, WHEN REMOVING THE DEVICE FROM THE PACKAGE. THERE WAS NO DAMAGE TO THE PACKAGING. 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 M00535900 13825879

    Patients

    Seq Age Sex Outcome Treatment
    1