BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPEL NEPHROURETERAL STENT SYSTEM WITH TWIST-LOC HUB

    MDR report key: 11654206 · Received April 12, 2021

    Report

    Report Number
    2134265-2021-04380
    Event Type
    Injury
    Date Received
    April 12, 2021
    Date of Event
    March 23, 2021
    Report Date
    July 29, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FAD
    UDI-DI
    08714729860938
    PMA / PMN Number
    K141344
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED FOR EVALUATION. THE RETURNED DEVICE WAS FOUND WITH THE SHAFT PROXIMAL SECTION DETACHED/SEPARATED. THE HUB SECTION WAS NOT RETURNED WITH THE DEVICE. THE CATHETER SHOWS EVIDENCE OF CUT AT SECTION DETACHED. ADDITIONALLY THE DEVICE SHOWS EVIDENCE CALCIFICATION AT DISTAL SECTION. UNDER MICROSCOPE INSPECTION THE PROXIMAL SECTION DETACHED SHOWS CUT EVIDENCE AND THE DISTAL SECTION IS CALCIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT BECAME SEPTIC. ON (B)(6) 2021, THE 8.3/24 EXPEL NEPHROURETERAL STENT SYSTEM WITH TWIST-LOC HUB WAS PLACED ON THE PATIENT. HOWEVER, THE DRAIN WAS OBSTRUCTED AND PATIENT BECAME SEPTIC AS A RESULT. DURING THE EXCHANGE ON (B)(6) 2021, THE REPLACEMENT DRAIN WOULD NOT FORM A PIGTAIL AT THE PROXIMAL END. THEY HAD TO REMOVE IT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THE PHYSICIAN IS CONCERNED THAT THE ORIGINAL DRAIN BECAME OBSTRUCTED SO SOON, ESPECIALLY IN A NU. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE DRAIN WAS PLACED IN THE LEFT KIDNEY. SEDIMENT CAUSED THE DEVICE TO BE OBSTRUCTED THAT LEAD TO SEPSIS. WHEN THE DRAIN WAS PLACED AND THE DOCTOR ATTEMPTED TO PULL ON THE SUTURE STRING TO FORM THE PIGTAIL THAT WOULD HOLD THE DRAIN IN PLACE INSIDE THE KIDNEY, THE DRAIN WOULD NOT FORM A PIGTAIL. PATIENT IS DOING WELL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT BECAME SEPTIC. ON (B)(6) 2021, THE 8.3/24 EXPEL NEPHROURETERAL STENT SYSTEM WITH TWIST-LOC HUB WAS PLACED ON THE PATIENT. HOWEVER, THE DRAIN WAS OBSTRUCTED AND PATIENT BECAME SEPTIC AS A RESULT. DURING THE EXCHANGE ON (B)(6) 2021, THE REPLACEMENT DRAIN WOULD NOT FORM A PIGTAIL AT THE PROXIMAL END. THEY HAD TO REMOVE IT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THE PHYSICIAN IS CONCERNED THAT THE ORIGINAL DRAIN BECAME OBSTRUCTED SO SOON, ESPECIALLY IN A NU. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE DRAIN WAS PLACED IN THE LEFT KIDNEY. SEDIMENT CAUSED THE DEVICE TO BE OBSTRUCTED THAT LEAD TO SEPSIS. WHEN THE DRAIN WAS PLACED AND THE DOCTOR ATTEMPTED TO PULL ON THE SUTURE STRING TO FORM THE PIGTAIL THAT WOULD HOLD THE DRAIN IN PLACE INSIDE THE KIDNEY, THE DRAIN WOULD NOT FORM A PIGTAIL. PATIENT IS DOING WELL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT BECAME SEPTIC. ON (B)(6) 2021, THE 8.3/24 EXPEL NEPHROURETERAL STENT SYSTEM WITH TWIST-LOC HUB WAS PLACED ON THE PATIENT. HOWEVER, THE DRAIN WAS OBSTRUCTED AND PATIENT BECAME SEPTIC AS A RESULT. DURING THE EXCHANGE ON (B)(6) 2021, THE REPLACEMENT DRAIN WOULD NOT FORM A PIGTAIL AT THE PROXIMAL END. THEY HAD TO REMOVE IT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THE PHYSICIAN IS CONCERNED THAT THE ORIGINAL DRAIN BECAME OBSTRUCTED SO SOON, ESPECIALLY IN A NU. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549780 EXPEL NEPHROURETERAL STENT SYSTEM WITH TWIST-LOC HUB STENT, URETERAL FAD BOSTON SCIENTIFIC CORPORATION 32899 0026353535 08714729860938

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R