BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESCAPE NITINOL STONE RETRIEVAL BASKET

    MDR report key: 807330 · Received January 19, 2007

    Report

    Report Number
    6000043-2007-00009
    Event Type
    Injury
    Date Received
    January 19, 2007
    Date of Event
    January 1, 2007
    Report Date
    January 4, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FFL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. SHOULD FURTHER RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED UNDER THE APPROPRIATE SEQUENCE NUMBER.

    Description of Event or Problem · 1

    THE COMPLAINANT HAS REPORTED THAT A FEMALE PATIENT (AGE UNKNOWN) UNDERWENT A THERAPEUTIC PROCEDURE FOR URETERAL STONE RETRIEVAL IN 2007. DURING THE ATTEMPT TO REMOVE A STONE THAT WAS INBEDDED IN THE URETER, THE ESCAPE BASKET BROKE. THE CLINICIAN REPORTED THAT "ALL FOUR PRONGS OF THE BASKET APPEARED TO HAVE DETACHED/BROKEN OFF". AT LEAST ONE OF THE PRONGS WAS RETRIEVED WITH A FORCEP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE IN CONJUNCTION WITH USE OF A LASER. UPON REMOVAL OF THE STONE, SOME BLEEDING WAS NOTED, WHICH WAS ATTRIBUTED TO LOCATION AND IMBEDDED STATE OF THE STONE. PATIENT CONDITION IS REPORTED AS "OK" UPON DISCHARGE. THE PATIENT WILL FOLLOW UP WITH THE PHYSICIAN "IN A FEW WEEKS" TO HAVE ENDOSCOPIC EVALUATION OF THE BLADDER AND URETER TO DETERMINE THE STATUS OF ANY FRAGMENTS OF THE BASKET THAT MAY BE RETAINED. PLEASE NOTE ASSOCIATED MEDWATCH REPORT 6000043-2007-00007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESCAPE NITINOL STONE RETRIEVAL BASKET FFL FFL BOSTON SCIENTIFIC M0063902010 9154320

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| R