BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCCLUDER

    MDR report key: 11663759 · Received April 14, 2021

    Report

    Report Number
    3005099803-2021-01736
    Event Type
    Injury
    Date Received
    April 14, 2021
    Date of Event
    March 24, 2021
    Report Date
    April 14, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EYB
    UDI-DI
    08714729161691
    PMA / PMN Number
    K133750
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. THE COMPLAINANT WAS UNABLE TO REPORT THE DEVICE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. (B)(4). ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OCCLUDER BALLOON CATHETER WAS USED IN THE URETER DURING A URETEROSCOPY WITH PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE BALLOON WAS INFLATED AND PLACED IN A TIGHT URETEROPELVIC JUNCTION (UPJ) STRICTURE IN WHICH CAUSED A SMALL TEAR IN THE URETER OF THE PATIENT. REPORTEDLY, A STENT WAS PLACED AND THE PROCEDURE WAS COMPLETED AT THIS TIME. THERE WAS NO ALLEGED MALFUNCTION OR DEFICIENCY OF THE OCCLUDER BALLOON CATHETER. IN THE PHYSICIAN'S ASSESSMENT, THE BALLOON BEING PLACED IN A TIGHT STRICTURE COULD HAVE CAUSED THE STRICTURE TO STRETCHED RESULTING TO A TEAR IN THE URETER OF THE PATIENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562994 OCCLUDER CATHETER, UROLOGICAL EYB BOSTON SCIENTIFIC CORPORATION M0062201100 08714729161691

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention