BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR SUREDRIVE

    MDR report key: 18508992 · Received January 12, 2024

    Report

    Report Number
    2124215-2023-75803
    Event Type
    Injury
    Date Received
    January 12, 2024
    Date of Event
    December 1, 2023
    Report Date
    May 30, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE, 12/01/2023, WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT, 12/20/2023. BLOCKS 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 (REPORT SOURCE): STUDY: BOSTON SCIENTIFIC UROLOGY CASE REPORT PAK ARMED FORCES MED J 2021; 71 (1): 45-50 BLOCK E1: INITIAL REPORTER FACILITY NAME: ARMED FORCES INSTITUTE OF UROLOGY/NATIONAL UNIVERSITY OF MEDICAL SCIENCES (NUMS) RAWALPINDI PAKISTAN. BLOCK H6: THE FOLLOWING IMDRF PATIENT CODES CAPTURE THE REPORTABLE EVENT OF: E1302 - HEMATURIA. E1605 - CRAMPS/MUSCLE SPASMS. E2330 - PAIN. E1310 - URINARY TRACT INFECTION. BLOCK H11: CORRECTION TO FIELD BLOCK E1: INITIAL REPORTER ADDRESS, INITIAL REPORTER ADDRESS 2. INITIAL REPORTER ADDRESS CITY. INITIAL REPORTER ADDRESS COUNTRY.

    Additional Manufacturer Narrative · 0

    BLOCK B3:THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE, 12/01/2023, WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT, 12/20/2023.BLOCKS 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 (REPORT SOURCE): STUDY: BOSTON SCIENTIFIC UROLOGY CASE REPORT PAK ARMED FORCES MED J 2021; 71 (1): 45-50BLOCK E1:INITIAL REPORTER FACILITY NAME: (B)(6).BLOCK H6:THE FOLLOWING IMDRF PATIENT CODES CAPTURE THE REPORTABLE EVENT OF:E1302 - HEMATURIAE1605 - CRAMPS/MUSCLE SPASMSE2330 - PAINE1310 - URINARY TRACT INFECTION.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF THE EVENT THROUGH THE ARTICLE, '"COMPARISON OF SOLIFENACIN VERSUS COMBINATION OF SOLIFENACIN AND TMASULOSIN IN IMPROVING UNILATERAL DOUBLE-J STENT RELATED LOWER URINARY TRACT SYMPTOMS'" MUHAMMAD TANVEER SAJID, SAMI UR REHMAN, MUHAMMAD AKMAL, HUSSAIN AHMAD, ZAHOOR IQBAL MIRZA, ARSHAD MAHMOOD ARMED FORCES INSTITUTE OF UROLOGY/NATIONAL UNIVERSITY OF MEDICAL SCIENCES. PER THE ARTICLE, A TOTAL OF TWO HUNDRED (N=200) PATIENTS WHO UNDERWENT UNILATERAL DJ STENTING FOR DIFFERENT ENDOUROLOGICAL PROCEDURES, WERE ENROLLED AFTER SATISFYING INCLUSION/EXCLUSION CRITERIA AND THEN RANDOMLY ALLOCATED TO 2 GROUPS. THE PATIENTS WERE CARRIED OUT UNDER GENERAL OR REGIONAL ANESTHESIA. A SOFT PERCUFLEX STENT WITH HYDRO PLUS (CONTOUR URETERAL STENT WAS USED, ADJUSTING THE LENGTH AND CALIBER FOR EACH PATIENT. THE PATIENTS IN THE STENT GROUP A RECEIVED SOLIFENACIN (5MG) AND PLACEBO FOR TWO WEEKS. THE PATIENTS IN STENT GROUP B RECEIVED SOLIFENACIN (5MG) TAMSULOSIN (0.4 MG) OD FOR 2 WEEKS. A PLAIN RADIOGRAPH OF THE KIDNEYS, URETERS, AND BLADDERS CONFIRMED THE POSITION OF THE STENTS IN THE PATIENTS, PRIOR TO DISCHARGE. THE STUDY INDICATED COMPLICATIONS IDENTIFIED AS RELATED TO URINARY MORBIDITIES ENCOUNTERED ARE VOIDING / STORAGE SYMPTOMS (LUTS), FLANK OR SUPRAPUBIC PAIN, HEMATURIA AND URINARY TRACT INFECTION (UTI) OBVIOUSLY AFFECTING GENERAL HEALTH AND WORK PERFORMANCE IN AS MANY AS 80% CASES. ALSO, SPASM OF URETERAL SMOOTH MUSCLE SECONDARY TO FOREIGN BODY IN SITU, IRRITATION OF TRIGONE BY INTRAVESICAL LOWER COIL LEADING TO BLADDER SPASM AND INCREASE RETROGRADE PRESSURE TRANS-MISSION DURING VOIDING ARE FEW SUCH PROPOSED MECHANISMS AUGMENTED BY NATURE OF MATERIAL AND SIZE OF THE STENT. GROUP A AND GROUP B WERE GIVEN MEDICATIONS TO DETERMINE THE BETTER TREATMENT FOR LUTS IN PATIENTS WITH INDWELLING URETERAL STENTS. THE CURRENT STUDY REVEALED SIGNIFICANT ADVANTAGE OF COMBINATION THERAPY (SOLIFENACIN +- TAMSULOSIN) COMPARED WITH SOLIFENACIN MONOTHERAPY IN LOWERING LUTS (LOWER URINARY TRACT SYMPTOMS) BASED ON IPSS (INTERNATIONAL PROSTATE SYMPTOM SCORE) IN PATIENTS HAVING UNILATERAL DJ STENT. ADDITIONAL INFORMATION IS UNAVAILABLE DESPITE GOOD FAITH EFFORTS.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF THE EVENT THROUGH THE ARTICLE, '"COMPARISON OF SOLIFENACIN VERSUS COMBINATION OF SOLIFENACIN AND TMASULOSIN IN IMPROVING UNILATERAL DOUBLE-J STENT RELATED LOWER URINARY TRACT SYMPTOMS'" MUHAMMAD TANVEER SAJID, SAMI UR REHMAN, MUHAMMAD AKMAL, HUSSAIN AHMAD, ZAHOOR IQBAL MIRZA, ARSHAD MAHMOOD ARMED FORCES INSTITUTE OF UROLOGY/NATIONAL UNIVERSITY OF MEDICAL SCIENCES.PER THE ARTICLE, A TOTAL OF TWO HUNDRED (N=200) PATIENTS WHO UNDERWENT UNILATERAL DJ STENTING FOR DIFFERENT ENDOUROLOGICAL PROCEDURES, WERE ENROLLED AFTER SATISFYING INCLUSION/EXCLUSION CRITERIA AND THEN RANDOMLY ALLOCATED TO 2 GROUPS. THE PATIENTS WERE CARRIED OUT UNDER GENERAL OR REGIONAL ANESTHESIA. A SOFT PERCUFLEX STENT WITH HYDRO PLUS (CONTOUR URETERAL STENT WAS USED, ADJUSTING THE LENGTH AND CALIBER FOR EACH PATIENT. THE PATIENTS IN THE STENT GROUP A RECEIVED SOLIFENACIN (5MG) AND PLACEBO FOR TWO WEEKS. THE PATIENTS IN STENT GROUP B RECEIVED SOLIFENACIN (5MG) TAMSULOSIN (0.4 MG) OD FOR 2 WEEKS. A PLAIN RADIOGRAPH OF THE KIDNEYS, URETERS, AND BLADDERS CONFIRMED THE POSITION OF THE STENTS IN THE PATIENTS, PRIOR TO DISCHARGE. THE STUDY INDICATED COMPLICATIONS IDENTIFIED AS RELATED TO URINARY MORBIDITIES ENCOUNTERED ARE VOIDING / STORAGE SYMPTOMS (LUTS), FLANK OR SUPRAPUBIC PAIN, HEMATURIA AND URINARY TRACT INFECTION (UTI) OBVIOUSLY AFFECTING GENERAL HEALTH AND WORK PERFORMANCE IN AS MANY AS 80% CASES. ALSO, SPASM OF URETERAL SMOOTH MUSCLE SECONDARY TO FOREIGN BODY IN SITU, IRRITATION OF TRIGONE BY INTRAVESICAL LOWER COIL LEADING TO BLADDER SPASM AND INCREASE RETROGRADE PRESSURE TRANS-MISSION DURING VOIDING ARE FEW SUCH PROPOSED MECHANISMS AUGMENTED BY NATURE OF MATERIAL AND SIZE OF THE STENT. GROUP A AND GROUP B WERE GIVEN MEDICATIONS TO DETERMINE THE BETTER TREATMENT FOR LUTS IN PATIENTS WITH INDWELLING URETERAL STENTS. THE CURRENT STUDY REVEALED SIGNIFICANT ADVANTAGE OF COMBINATION THERAPY (SOLIFENACIN +- TAMSULOSIN) COMPARED WITH SOLIFENACIN MONOTHERAPY IN LOWERING LUTS (LOWER URINARY TRACT SYMPTOMS) BASED ON IPSS (INTERNATIONAL PROSTATE SYMPTOM SCORE) IN PATIENTS HAVING UNILATERAL DJ STENT.ADDITIONAL INFORMATION IS UNAVAILABLE DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1701964 CONTOUR SUREDRIVE STENT, URETERAL FAD BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention