BEUDAMED
    FDA Adverse Event Other Summary report: N

    STONETOME DISPOSABLE SPHINCTEROTOME

    MDR report key: 446878 · Received March 7, 2003

    Report

    Report Number
    6000048-2003-00007
    Event Type
    Other
    Date Received
    March 7, 2003
    Date of Event
    February 2, 2003
    Report Date
    February 11, 2003
    Manufacturer
    MICROVASIVE ENDOSCOPY, A DIVISION OF BOSTON SCIENTIFIC CORP.
    Product Code
    FDR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING AN ERCP PROCEDURE FOR TREATMENT, THE STONETOME DEVICE PERFORATED THE PATIENT'S AMPULLA. THE PROCEDURE WITH THIS DEVICE HAD ALREADY BEEN COMPLETED WHEN THE PERFORATION WAS NOTICED. THIS WAS ORIGINALLY AN OUT-PATIENT PROCEDURE, BUT AS A RESULT OF THE PERFORATION, THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE PATIENT WAS MONITORED FOR THE PERFORATION AND THE RESULTING FREE AIR UNDER THE SKIN. THE PERFORATION WAS REPORTED AS HEALING AND THE FREE AIR CORRECTED ITSELF BY ABSORBING INTO THE BODY. IT WAS REPORTED THAT THE HOSPITAL STAY WAS A COUPLE OF DAYS, THEN THE PATIENT WAS RELEASED FROM THE HOSPITAL TO GO HOME. THE EXACT DATE OF RELEASE COULD NOT BE CONFIRMED BY THE HOSPITAL. UPON EVALUATION OF THE DEVICE BY THIS MANUFACTURER, IT WAS DETERMINED THAT REPEATED ROTATIONS OF THE HANDLE DURING USE MAY HAVE CAUSED THE TWISTS IN THE WORKING LENGTH AND THUS TWISTS IN THE CUTTING WIRE ORIENTATION. THE FUNCTIONAL ANALYSIS FOUND THAT REALIGNMENT OF THE DEVICE ALLOWED IT TO ORIENT PROPERLY WHEN ACTIVATED, INDICATING THAT THE DEVICE WAS PROPERLY ORIENTED DURING ASSEMBLY. USER TECHNIQUE AND/OR PATIENT ANATOMY MAY HAVE CONTRIBUTED TO THIS EVENT. HOWEVER, THE CO IS UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STONETOME DISPOSABLE SPHINCTEROTOME DISPOS. SPHINCTEROTOME FDR MICROVASIVE ENDOSCOPY, A DIVISION OF BOSTON SCIENTIFIC CORP. NA 5092258

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Hospitalization