BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEGURA HEMISPHERE STONE RETRIEVAL BASKET

    MDR report key: 1910653 · Received November 30, 2010

    Report

    Report Number
    3005099803-2010-04946
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Report Date
    November 10, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    K935725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS NOT KNOWN PER THE COMPLAINANT; THEREFORE, THE DEVICE MANUFACTURE AND EXPIRATION DATES CANNOT BE DETERMINED. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS DISPOSED OF AND IS NOT AVAILABLE FOR EVALUATION. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THIS EVENT. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE FIRST OF THREE DEVICES USED IN THE SAME PROCEDURE. REFER TO THE ASSOCIATED MANUFACTURER REPORT NUMBER 3005099803-2010-04949 FOR A DESCRIPTION OF THE SECOND DEVICE, AND 3005099803-2010-04948 FOR A DESCRIPTION OF THE THIRD DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2010 THAT A SEGURA HEMISPHERE STONE RETRIEVAL BASKET WAS USED IN AN UNKNOWN PROCEDURE (PATIENT ID, AGE, GENDER, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, THE RETRIEVAL BASKET "FAILED" DURING THE PROCEDURE. THE NATURE OF THE MALFUNCTION, PATIENT, AND PROCEDURE SPECIFICS ARE REPORTED TO BE UNAVAILABLE. THE PROCEDURE WAS COMPLETED WITH A GEMINI PAIRED WIRE HELICAL BASKET. 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 SEGURA HEMISPHERE STONE RETRIEVAL BASKET DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC - SPENCER M0063801100

    Patients

    Seq Age Sex Outcome Treatment
    1