BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR

    MDR report key: 9136721 · Received September 30, 2019

    Report

    Report Number
    3005099803-2019-04770
    Event Type
    Injury
    Date Received
    September 30, 2019
    Date of Event
    March 31, 2017
    Report Date
    September 30, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZB
    UDI-DI
    08714729302681
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (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 A SENSOR GUIDEWIRE WAS USED IN THE LEFT KIDNEY DURING A LEFT URETEROSCOPY WITH LASER STONE FRAGMENTATION AND INSERTION OF A JJ STENT (MANUFACTURER UNKNOWN) PERFORMED ON OR AROUND (B)(6) 2017. ACCORDING TO THE COMPLAINANT, THE PROCEDURE WAS INDICATED FOR A RENAL PELVIC STONE AND A POORLY FUNCTIONING KIDNEY. DURING THE PROCEDURE, THE SOFT END OF THE SENSOR GUIDEWIRE DETACHED AND REMAINED IN THE PATIENT'S RENAL PELVIS FOLLOWING THE INSERTION OF THE JJ STENT. THE PHYSICIAN PLANNED ON REPEATING THE URETEROSCOPY IN 2-4 WEEKS FOR "REMOVAL OF STENT FRAGMENTS AND RESIDUALS STONES". REPORTEDLY, THE PROXIMAL END OF THE SENSOR GUIDEWIRE WAS SEPARATED FROM THE REST OF THE STENT AND REMAINED IN SITU. ON (B)(6) 2017, THE PATIENT UNDERWENT A SECOND LEFT URETEROSCOPY FOR THE RESIDUAL STONES, WITH THE INTENTION OF LOCATING AND REMOVING THE RETAINED GUIDEWIRE FRAGMENT AT THE SAME TIME. PROCEDURE NOTES REVEALED THAT "4 X 2 MM FRAGMENTS IN THE LEFT URETER" AND THE PREVIOUSLY INSERTED JJ STENT "WAS SUSPECTED TO BE IN THE RENAL PELVIS, BUT THERE WAS NO ACCESS TO THE CALYCES AND THE FRAGMENT OF THE GUIDEWIRE". THE PHYSICIAN WAS UNABLE TO ACCESS OR REMOVE THE GUIDEWIRE FRAGMENT. ON (B)(6) 2017, THE PATIENT HAD UNDERWENT COMPUTERIZED TOMOGRAPHY (CT) SCAN OF HIS URINARY TRACT WHICH SHOWED THE RESIDUAL STONE IN THE LOWER CALYX AND THE DETACHED GUIDEWIRE FRAGMENT IN THE UPPER PART OF THE COLLECTING SYSTEM. THE CT SCAN PROCEDURE REPORT REVEALED "A PRESENT MODERATE LEFT HYDRONEPHROSIS LIKELY SECONDARY TO A STRICTURE AT THE PELVIS/PUJ. THIS REGION APPEARS THICKENED AROUND THE CALCULUS. THE PROXIMAL END OF THE URETERIC STENT APPEARS TO BE LYING AT OR SLIGHTLY INFERIOR TO THIS THICKENING/STRICTURE IN THE RENAL PELVIS. THE FRAGMENTED GUIDEWIRE HAS EMBEDDED IN THE THICKENED RENAL PELVIS CLOSE TO THE STENT AND THE OTHER END INSEPARABLE FROM THE RENAL PARENCHYMA IN THE ANTERIOR LOWER CALYX". ON (B)(6) 2018, THE PATIENT HAD UNDERWENT A LAPAROSCOPIC NEPHRECTOMY OF HIS LEFT KIDNEY DUE TO A NON-FUNCTIONING KIDNEY. PROCEDURE NOTES CONFIRMED THAT A GUIDEWIRE WAS PRESENT IN THE TISSUE OF THE LOWER POLE OF THE KIDNEY. ADDITIONAL INFORMATION REGARDING THE DETAILS OF THE THIS EVENT IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929416 SENSOR STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC CORPORATION M0066703081 0020096301 08714729302681

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R| S