BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SPHINCTEROTOME

    MDR report key: 1852999 · Received October 5, 2010

    Report

    Report Number
    3005099803-2010-04146
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Report Date
    September 16, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED AND THE ROOT CAUSE COULD NOT BE DETERMINED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX SPHINCTEROTOME WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). ACCORDING TO THE COMPLAINANT, DURING INSPECTION OF THE DEVICE WHILE PREPARING FOR THE PROCEDURE, IT WAS OBSERVED THAT THE STYLET ON THE END OF THE HYDRATOME RX HAD PIERCED THE CATHETER. THERE WAS NO VISIBLE DAMAGE TO THE PACKAGING. A SECOND HYDRATOME RX SPHINCTEROTOME WAS USED TO COMPLETE THE PROCEDURE WITHOUT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRATOME RX SPHINCTEROTOME UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - SPENCER M00583040 13507860

    Patients

    Seq Age Sex Outcome Treatment
    1