BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMTOME RX SPHINCTEROTOME

    MDR report key: 2093309 · Received May 18, 2011

    Report

    Report Number
    3005099803-2011-01666
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 27, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT 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 A DREAMTOME RX SPHINCTEROTOME WAS TO BE USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE DEVICE'S PACKAGE WAS OPENED AND THE NURSE NOTED THAT THE END OF THE TOME WAS FRAYED, AND THE COATING/BLUE PAINT WAS PEELING FROM THE TIP. THE DEVICE WAS ADVANCED INTO THE ERCP SCOPE BUT IT WAS NOT ADVANCED INTO THE PATIENT'S COMMON BILE DUCT; NO PAINT DETACHED INSIDE THE PATIENT. THE PHYSICIAN REQUESTED THE NURSE TO REMOVE THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DREAMTOME 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 DREAMTOME RX SPHINCTEROTOME UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - SPENCER M00584050 0013839746

    Patients

    Seq Age Sex Outcome Treatment
    1