BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STONETOME STONE RETRIEVAL DEVICE

    MDR report key: 1437693 · Received April 15, 2009

    Report

    Report Number
    3005099803-2009-01778
    Event Type
    Malfunction
    Date Received
    April 15, 2009
    Date of Event
    March 16, 2009
    Report Date
    March 19, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDI
    PMA / PMN Number
    K930022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (WILL NOT BOW). THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURER DATE AND EXPIRATION DATE ARE UNKNOWN. THE DEVICE HAS BEEN RECEIVED BY THIS MANUFACTURER, HOWEVER, THE INVESTIGATION HAS NOT YET BEEN PERFORMED. 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. (B) (4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MARCH 19, 2009, THAT A STONETOME RX SPHINCTEROTOME WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON (B) (6), 2009. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE WOULD NOT BOW INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME STONETOME 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 STONETOME STONE RETRIEVAL DEVICE FDI BOSTON SCIENTIFIC CORPORATION M00535150 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK