BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPHROMAX

    MDR report key: 10596746 · Received September 28, 2020

    Report

    Report Number
    3005099803-2020-04261
    Event Type
    Malfunction
    Date Received
    September 28, 2020
    Date of Event
    September 2, 2020
    Report Date
    September 28, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LJE
    UDI-DI
    08714729826484
    PMA / PMN Number
    K121614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WEIGHT: (B)(6) KG. (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

    NOTE: THIS REPORT PERTAINS TO THREE NEPHROMAX DILATATION BALLOON CATHETERS THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE NEPHROMAX DILATATION BALLOON CATHETERS WERE USED IN THE RIGHT KIDNEY DURING A RIGHT PERCUTANEOUS NEPHROLITHONOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOONS RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEPHROMAX DILATATION BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1060122 NEPHROMAX CATHETER, NEPHROSTOMY LJE BOSTON SCIENTIFIC CORPORATION M0062101400 0024983478 08714729826484

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR