BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZERO TIP RETRIEVAL BASKET

    MDR report key: 872391 · Received June 28, 2007

    Report

    Report Number
    6000043-2007-00080
    Event Type
    Injury
    Date Received
    June 28, 2007
    Report Date
    June 6, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FFL
    PMA / PMN Number
    K020765
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE. THREE POSSIBLE LOTS HAVE BEEN IDENTIFIED FOR THE DEVICE: 9136940, 9141778, AND 9146512. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED ON THESE LOTS; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE FOR SIMILAR COMPLAINTS WAS CONDUCTED; NO ADDITIONAL COMPLAINTS HAVE BEEN RECORDED FOR THESE LOTS. THE MAY 2007 15-MONTH ZERO TIP COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; AN UNFAVORABLE TREND WAS NOTED. AN UNFAVORABLE TREND IS DEFINED AS TWO CONSECUTIVE INCREASING DATA POINTS. THE TREND REPORT REVEALS SOME COMPLAINTS REPORTED IN THE MONTH OF MARCH 2007, AND SOME REPORTED IN THE MONTH OF APRIL 2007, AND SOME COMPLAINTS REPORTED IN THE MONTH OF MAY 2007. A CAR HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A THERAPEUTIC STONE RETRIEVAL PROCEDURE RECENTLY OCCURRED (DATE UNKNOWN) USING OUR ZERO TIP RETRIEVAL BASKET. DURING THE PROCEDURE, THE BASKET BECAME STUCK IN THE PATIENT'S URETER, WHEN ATTEMPTING TO WITHDRAW THE DEVICE. THE PHYSICIAN HAD TO CUT THE BASKET WIRES IN ORDER TO FREE THE DEVICE FROM THE PATIENT'S URETER. ONE OF THE BASKET WIRES DETACHED INSIDE THE PATIENT DUE TO THIS EVENT. THE PATIENT WAS KEPT OVERNIGHT FOR OBSERVATION. THE FOLLOWING DAY, THE PHYSICIAN RETRIEVED THE BASKET WIRE WITH GRASPERS. NO PATIENT COMPLICATION SUSTAINED AS A RESULT OF THE DETACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZERO TIP RETRIEVAL BASKET FFL BOSTON SCIENTIFIC M0063901050

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| R