BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESCAPE

    MDR report key: 11800982 · Received May 10, 2021

    Report

    Report Number
    3005099803-2021-02059
    Event Type
    Injury
    Date Received
    May 10, 2021
    Date of Event
    April 1, 2021
    Report Date
    May 10, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FFL
    UDI-DI
    08714729121299
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT. THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ESCAPE BASKET WAS USED IN THE URETER DURING A URETEROSCOPY AND STONE EXTRACTION PROCEDURE PERFORMED ON UNKNOWN DATE. DURING THE PROCEDURE, A STONE WAS CAUGHT IN THE ESCAPE BASKET. THE SCOPE WAS PULLED BACK WITH THE BASKET AND STONE, BUT THE BASKET PERFORATED THE DISTAL URETER. THE BASKET WAS REMOVED FROM THE PATIENT BY CUTTING THE WIRES ABOVE THE HANDLE. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698432 ESCAPE DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC CORPORATION M0063902010 08714729121299

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention