BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIMA CATHETER

    MDR report key: 18771675 · Received February 23, 2024

    Report

    Report Number
    2124215-2024-09544
    Event Type
    Injury
    Date Received
    February 23, 2024
    Date of Event
    July 1, 2021
    Report Date
    February 23, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FFA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: DATE OF EVENT: APPROXIMATED TO JULY 01, 2021, BASED ON THE DATE THE ARTICLE WAS RECEIVED ON JULY 03, 2021. 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 E1: INITIAL REPORTER FACILITY NAME: (B)(6). BLOCK G2 (REPORT SOURCE): JOURNAL ARTICLE: DEVRIM AKINCI., ET AL, 'MANAGEMENT OF SINGLE DOUBLE-J STENT FAILURE IN MALIGNANT URETERAL OBSTRUCTION: TANDEM URETERAL STENTING WITH LESS FREQUENT STENT EXCHANGE' DIAGN INTERV RADIOL 2023; DOI: 10.5152/DIR.2022.21638. BLOCK H6: IMDRF DEVICE CODE A1409 CAPTURES THE REPORTABLE EVENT OF STENT OBSTRUCTED. IMDRF PATIENT CODES CAPTURE THE FOLLOWING REPORTABLE PATIENTS' ADVERSE OF EVENTS: E1311: UNSPECIFIED KIDNEY OR URINARY PROBLEM. E1302: HEMATURIA. E1310: URINARY TRACT INFECTION. E1906 CAPTURES THE REPORTABLE EVENT OF PYONEPHROSIS.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF THE EVENT THROUGH THE ARTICLE 'MANAGEMENT OF SINGLE DOUBLE-J STENT FAILURE IN MALIGNANT URETERAL OBSTRUCTION: TANDEM URETERAL STENTING WITH LESS FREQUENT STENT EXCHANGE'. DEVRIM AKINCI, EMRE UNAL, TURKMEN TURAN CIFTCI, ORHAN SEREF OZKAN, OKAN AKHAN. PER THE ARTICLE, A TOTAL OF 11 (10 FEMALE) PATIENTS WITH AN AGE RANGE OF 27 TO 64, MEDIAN OF 49 YEARS, UNDERWENT TANDEM URETERAL STENTS (TUS) PLACEMENT DUE TO SINGLE DJS FAILURE OCCURRING IN LESS THAN 3 MONTHS. AN EXCHANGE OF TUS WAS ALSO PERFORMED IN 7 PATIENTS. TUS EXCHANGES WERE PERFORMED INITIALLY AT 6-MONTH INTERVALS, AND SUBSEQUENT EXCHANGE INTERVALS WERE EXTENDED TO 9 AND 12 MONTHS AFTER OBSERVING THE PATENCY OF TUS. ULTRASOUND EXAMINATIONS WERE ROUTINELY PERFORMED ON FOLLOW UP EVERY 3 MONTHS AFTER TUS PLACEMENT. AFTER THE INITIAL PLACEMENT OF TANDEM URETERAL STENTS (TUS) IN 14 URETERS, 41 EXCHANGE PROCEDURES WERE PERFORMED IN 10 URETERS OF 7 PATIENTS ON 28 OCCASIONS WITH A TECHNICAL SUCCESS RATE OF 100 PERCENT. TANDEM URETERAL STENTS (TUS) EXCHANGE PROCEDURES WERE PERFORMED 22 TIMES IN ONE PATIENT FOR BOTH URETERS (11 TIMES EACH), 8 TIMES IN ONE PATIENT, 5 TIMES IN ONE PATIENT, ONCE IN TWO PATIENTS, AND ONCE IN TWO PATIENTS FOR BOTH URETERS (TOTAL OF FOUR PROCEDURES IN TWO PATIENTS). THE MEDIAN DURATION OF URINARY PATENCY WAS SIGNIFICANTLY HIGHER WITH TUS 300 DAYS (RANGE, 60 TO 440 DAYS) COMPARED WITH SINGLE DJSS (45 DAYS (RANGE 35 TO 60 DAYS). IN 9 OUT OF 55 URETERS WITH TUS, PATIENTS PRESENTED WITH HYDRONEPHROSIS DUE TO STENT OCCLUSION AT AN OCCLUSION AT A MEDIAN FOLLOW-UP OF 315 DAYS (RANGE, 210 TO 365 DAYS). IN THREE URETERS OF TWO PATIENTS WITH TUS OCCLUSION, TEMPORARY NEPHROSTOMY WAS PERFORMED DUE TO PYONEPHROSIS. AFTER 1 MONTH WITH TEMPORARY NEPHROSTOMY AND SUBSEQUENT TUS EXCHANGE, THESE TWO PATIENTS WERE CATHETER FREE WITH NORMAL RENAL FUNCTION ON FOLLOW-UP. HOWEVER, ONE OF THESE TWO PATIENTS UNDERWENT PERMANENT NEPHROSTOMY 1535 DAYS AFTER TEMPORARY NEPHROSTOMY AND FIVE TUS EXCHANGE PROCEDURES BECAUSE OF BORDERLINE RENAL FUNCTION. ALSO, PYONEPHROSIS WAS DETECTED IN 5 OUT OF 55 URETERS WITH TUS (9%) IN TWO PATIENTS AS A GRADE 3 LATE COMPLICATION AFTER 210, 335, 365 DAYS OF PATENCY, THIS WAS MANAGED WITH PERCUTANEOUS NEPHROSTOMY AND TUS EXCHANGE PROCEDURES. URINARY TRACT INFECTION (N EQUALS 4, 36.36 PERCENT), LOWER URINARY TRACT SYMPTOMS (N EQUALS 3, 27.27PERCENT), AND HEMATURIA (N EQUALS 3, 27.27 PERCENT) WERE THE GRADE 2 LATE COMPLICATIONS. HEMATURIA WAS MANAGED CONSERVATIVELY AND RESOLVED OVER TIME. URINARY TRACT INFECTION WAS MANAGED WITH OUTPATIENT ORAL ANTIBIOTIC THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125964 FLEXIMA CATHETER TUBE, DRAINAGE, SUPRAPUBIC FFA BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention