BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESCAPE

    MDR report key: 14753304 · Received June 21, 2022

    Report

    Report Number
    3005099803-2022-03399
    Event Type
    Malfunction
    Date Received
    June 21, 2022
    Date of Event
    May 25, 2022
    Report Date
    June 21, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FFL
    UDI-DI
    08714729121299
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ESCAPE BASKET WAS USED IN THE KIDNEY DURING A LASER LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHEN THE ESCAPE BASKET WAS TO BE INSERTED BACK IN THE SCOPE, THE DISTAL END OF THE SHEATH WAS TORN. A ZERO TIP BASKET WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201478 ESCAPE DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC CORPORATION M0063902010 0026822883 08714729121299

    Patients

    Seq Age Sex Outcome Treatment
    1 Female