BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVIGATOR

    MDR report key: 19374449 · Received May 22, 2024

    Report

    Report Number
    2124215-2024-31023
    Event Type
    Injury
    Date Received
    May 22, 2024
    Date of Event
    February 1, 2020
    Report Date
    June 18, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE MONTH AND YEAR THE FIRST PROCEDURES WERE PERFORMED. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK G2: ELSAQA, M., HYDER, Z., THAI, K., DOWD, K., MEKRESH, A. E., WAGNER, K., PATEL, B., LOWRY, P., & TAYEB, M. M. E. (2023). COMPARISON OF COMMONLY UTILIZED URETERAL ACCESS SHEATHS: A PROSPECTIVE RANDOMIZED TRIAL. ARCHIVIO ITALIANO DI UROLOGIA ANDROLOGIA. HTTPS://DOI.ORG/10.4081/AIUA.2023.11149. BLOCK H6: IMDRF PATIENT CODE E2114 CAPTURES THE REPORTABLE EVENT OF PERFORATION. IMDRF PATIENT CODE E2330 CAPTURES THE REPORTABLE EVENT OF PAIN. IMDRF PATIENT CODE E1302 CAPTURES THE REPORTABLE EVENT OF HEMATURIA. IMDRF IMPACT CODE F23 CAPTURES THE REPORTABLE EVENT OF UNEXPECTED MEDICAL INTERVENTION. BLOCK H11: CORRECTION FIELD BLOCK H6.

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE MONTH AND YEAR THE FIRST PROCEDURES WERE PERFORMED. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK G2: ELSAQA, M., HYDER, Z., THAI, K., DOWD, K., MEKRESH, A. E., WAGNER, K., PATEL, B., LOWRY, P., & TAYEB, M. M. E. (2023). COMPARISON OF COMMONLY UTILIZED URETERAL ACCESS SHEATHS: A PROSPECTIVE RANDOMIZED TRIAL. ARCHIVIO ITALIANO DI UROLOGIA ANDROLOGIA. HTTPS://DOI.ORG/10.4081/AIUA.2023.11149 BLOCK H6: IMDRF PATIENT CODE E2114 CAPTURES THE REPORTABLE EVENT OF PERFORATION IMDRF IMPACT CODE F23 CAPTURES THE REPORTABLE EVENT OF UNEXPECTED MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING NAVIGATOR HD THROUGH THE ARTICLE, COMPARISON OF COMMONLY UTILIZED URETERAL ACCESS SHEATHS: A PROSPECTIVE RANDOMIZED TRIAL, BY MOHAMED ELSAQA ET AL. PER THE ARTICLE, THE STUDY'S AIM WAS TO EVALUATE AND COMPARE THE FUNCTIONAL CHARACTERISTICS AND SAFETY PROFILE AND EFFECTIVENESS OF TWO COMMONLY USED URETERAL ACCESS SHEATHS (UAS) DURING FLEXIBLE URETEROSCOPY. THE PATIENTS WITH PROXIMAL URETERAL OR KIDNEY STONES REQUIRING FLEXIBLE URETEROSCOPY AND UAS WERE PROSPECTIVELY RANDOMIZED TO THE USE OF BOSTON SCIENTIFIC NAVIGATOR HD (GROUP I) OR A NON-BOSTON SCIENTIFIC UAS (GROUP II). THERE WERE PATIENTS ENROLLED IN THE STUDY, 44 IN EACH GROUP. SHEATH SIZE 12/14 FR WAS USED IN BOTH COHORTS. MEDIAN STONE SIZE WAS 10 MM (7-13.5) AND 10.5 MM (7.37-14) IN GROUPS I AND II RESPECTIVELY (P EQUALS 0.915). IN GROUPS, I AND II, 19 AND 20 PATIENTS WERE PRESENTED. THE TRAXER GRADE 1 URETERAL INJURY WAS NOTED IN 5 AND 6 PATIENTS IN GROUPS I AND II RESPECTIVELY WHILE GRADE 3 INJURY WAS SEEN IN 1 PATIENT FOR BOTH COHORTS (P EQUAL 0.338). THERE WAS LESS RESISTANCE FOR UAS PLACEMENT IN PRESENTED PATIENTS (P = 0.0202) BUT WITHOUT A SIGNIFICANT DIFFERENCE IN URETERIC INJURY INCIDENCE (P = 0.175). EMERGENCY DEPARTMENT VISITS WERE ENCOUNTERED IN 7 (GROUP I) AND 5 PATIENTS (GROUP II) (P = 0.534); HOWEVER, THESE VISITS WERE REPORTED TO BE UNRELATED TO SHEATH COMPLICATION. THE STUDY FOUND THAT UASS WERE COMPARABLE REGARDING SAFETY AND EFFICACY IN THE CURRENT STUDY FOR UTILIZATION DURING FLEXIBLE URETEROSCOPY AND RETROGRADE INTRARENAL SURGERY. MOREOVER, THE PRESENTED AND DILATED URETERS HAVE LESS RESISTANCE TO INSERTION; HOWEVER, THIS DOES NOT RESULT IN A LOWER INCIDENCE OF ASSOCIATED URETERIC INJURY. FURTHERMORE, ALL URETERAL INJURIES WERE TREATED WITH STENT PLACEMENT FOR 2 TO 4 WEEKS.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING NAVIGATOR HD THROUGH THE ARTICLE, COMPARISON OF COMMONLY UTILIZED URETERAL ACCESS SHEATHS: A PROSPECTIVE RANDOMIZED TRIAL, BY MOHAMED ELSAQA ET AL. PER THE ARTICLE, THE STUDY'S AIM WAS TO EVALUATE AND COMPARE THE FUNCTIONAL CHARACTERISTICS AND SAFETY PROFILE AND EFFECTIVENESS OF TWO COMMONLY USED URETERAL ACCESS SHEATHS (UAS) DURING FLEXIBLE URETEROSCOPY. THE PATIENTS WITH PROXIMAL URETERAL OR KIDNEY STONES REQUIRING FLEXIBLE URETEROSCOPY AND UAS WERE PROSPECTIVELY RANDOMIZED TO THE USE OF BOSTON SCIENTIFIC NAVIGATOR HD (GROUP I) OR A NON-BOSTON SCIENTIFIC UAS (GROUP II). THERE WERE PATIENTS ENROLLED IN THE STUDY, 44 IN EACH GROUP. SHEATH SIZE 12/14 FR WAS USED IN BOTH COHORTS. MEDIAN STONE SIZE WAS 10 MM (7-13.5) AND 10.5 MM (7.37-14) IN GROUPS I AND II RESPECTIVELY (P EQUALS 0.915). IN GROUPS, I AND II, 19 AND 20 PATIENTS WERE PRESENTED. THE TRAXER GRADE 1 URETERAL INJURY WAS NOTED IN 5 AND 6 PATIENTS IN GROUPS I AND II RESPECTIVELY WHILE GRADE 3 INJURY WAS SEEN IN 1 PATIENT FOR BOTH COHORTS (P = 0.338). THERE WAS LESS RESISTANCE FOR UAS PLACEMENT IN PRESENTED PATIENTS (P = 0.0202) BUT WITHOUT A SIGNIFICANT DIFFERENCE IN URETERIC INJURY INCIDENCE (P = 0.175). EMERGENCY DEPARTMENT VISITS WERE ENCOUNTERED IN 7 (GROUP I) AND 5 PATIENTS (GROUP II) (P = 0.534); HOWEVER, THESE VISITS WERE REPORTED TO BE UNRELATED TO SHEATH COMPLICATION. THE STUDY FOUND THAT UASS WERE COMPARABLE REGARDING SAFETY AND EFFICACY IN THE CURRENT STUDY FOR UTILIZATION DURING FLEXIBLE URETEROSCOPY AND RETROGRADE INTRARENAL SURGERY. MOREOVER, THE PRESENTED AND DILATED URETERS HAVE LESS RESISTANCE TO INSERTION; HOWEVER, THIS DOES NOT RESULT IN A LOWER INCIDENCE OF ASSOCIATED URETERIC INJURY. FURTHERMORE, ALL URETERAL INJURIES WERE TREATED WITH STENT PLACEMENT FOR 2 TO 4 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1787934 NAVIGATOR ENDOSCOPE AND/OR ACCESSORIES KOD BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention