BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZERO TIP NITINOL STONE RETRIEVAL BASKET

    MDR report key: 2142476 · Received June 28, 2011

    Report

    Report Number
    3005099803-2011-02106
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT WAS DISPOSED; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO TIP NITINOL RETRIEVAL BASKET WAS USED IN A URETEROSCOPY PROCEDURE (PATIENT WEIGHT UNKNOWN). ACCORDING TO THE COMPLAINANT, THE BASKET BECAME ENTRAPPED ON A LARGE STONE AND WAS UNABLE TO BE REMOVED. THE PHYSICIAN COULD NOT SEE TO USE A LASER OR LITHOTRIPSY TO REMOVE THE BASKET. SINCE THIS FACILITY IS NOT EQUIPPED WITH EQUIPMENT TO REACH THE STONE, THE PHYSICIAN LEFT THE BASKET IN PLACE AND CUT THE HANDLE. THE PATIENT RETURNED TO THE HOSPITAL ON AN UNKNOWN DATE (WEEK OF (B)(6), 2011) FOR AN OPEN SURGICAL PROCEDURE. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE BASKET FRAGMENT. NO ADDITIONAL PROCEDURES ARE PLANNED FOR THIS PATIENT. THE PATIENT WAS REPORTED TO BE DOING "FINE" AT THE CONCLUSION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZERO TIP NITINOL STONE RETRIEVAL BASKET DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC - SPENCER M0063901030 14214279

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention