BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERCUFLEX PLUS

    MDR report key: 18108083 · Received November 9, 2023

    Report

    Report Number
    2124215-2023-61256
    Event Type
    Death
    Date Received
    November 9, 2023
    Date of Event
    October 1, 2021
    Report Date
    November 9, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FAD
    UDI-DI
    08714729056812
    PMA / PMN Number
    K924608
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B2: DATE OF DEATH WAS AROUND OCTOBER 2021. BLOCK B3: EXACT DATE UNKNOWN. THE PROVIDED EVENT DATE WAS APPROXIMATED BASED ON THE CLINIC VISIT AROUND OCTOBER 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 D6: IMPLANT DATE WAS AROUND OCTOBER 2021. BLOCK G2 (REPORT SOURCE): STUDY: BOSTON SCIENTIFIC UROLOGY CASE REPORT 44 (2022) 102128 BLOCK H6: IMDRF DEVICE CODE A010402 CAPTURES THE REPORTABLE EVENT OF STENT MIGRATION. IMDRF DEVICE CODE A1502 CAPTURES THE REPORTABLE EVENT OF STENT POSITIONING PROBLEM. IMDRF DEVICE CODE A0406 CAPTURES THE REPORTABLE EVENT OF STENT DEFORMED INSIDE THE PATIENT. IMDRF DEVICE CODE A1409 CAPTURES THE REPORTABLE EVENT OF DEVICE OBSTRUCTION OF FLOW. IMDRF PATIENT CODE E233605 CAPTURES THE REPORTABLE EVENT OF SEPTIC SHOCK. IMDRF PATIENT CODE E2402 CAPTURES THE REPORTABLE EVENT OF ABDOMINAL DISTENTION. IMDRF PATIENT CODE E2314 CAPTURES THE REPORTABLE EVENT OF THE FISTULA. IIMDRF PATIENT CODE E1906 CAPTURES THE REPORTABLE EVENT OF INTRA-ABDOMINAL INFECTION. IMDRF PATIENT CODE E1002 CAPTURES THE REPORTABLE EVENT OF ABDOMINAL PAIN. IMDRF PATIENT CODE E2101 CAPTURES THE REPORTABLE EVENT OF INTRAPERITONEAL ADHESION. IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF DEATH.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO A ZEBRA GUIDEWIRES (MFR REPORT # 3005099803-2023-05875 AND PERCUFLEX PLUS (MFR REPORT #2124215-2023-61256) THAT WERE USED IN THE SAME PROCEDURE. BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF THE FOLLOWING EVENT THROUGH THE ARTICLE "A DOUBLE-J STENT MISGUIDED BY ZEBRA GUIDEWIRE INTO ILEUM: A CASE REPORT AND LITERATURE REVIEW", BY LIANGCHENG LIU, GUIHUA CAO, GUIMIN HUANG, JIANPING DU, WEI LI, QIANG LI. ACCORDING TO THE ARTICLE, THE PATIENT HAD A LAPAROSCOPIC LEFT NEPHRO-URETERECTOMY AND CONTRALATERAL END CUTANEOUS URETEROSTOMY, WITH REGULAR DOUBLE-J STENTING EVERY 3 MONTHS FOR THE PATIENT'S STOMAL STENOSIS. THREE MONTHS AFTER THE SURGERY THE PATIENT UNINTENTIONALLY PULLED OUT THEIR DOUBLE-J STENT AND A ZEBRA GUIDEWIRE WAS USED TO REPLACE THE DOUBLE J-STENT AROUND OCTOBER 2011. FOLLOWING THE STENT PLACEMENT, WHILE THE PATIENT WAS UNDER OBSERVATION, IT WAS NOTED THAT THERE WAS NO DRAINAGE FLUID IN THE PATIENT'S OSTOMY BAG FOR 12 HOURS, AND THE DOUBLE-J STENT DISAPPEARED IN THE ABDOMINAL WALL. AN ABDOMINAL PELVIC CT WAS PERFORMED, AND IT WAS FOUND THAT THERE WAS HYDRONEPHROSIS IN THE RIGHT KIDNEY AND THE STENT WAS LOCATED IN THE ILEUM. THE PATIENT WAS GIVEN A GASTROINTESTINAL MOTILITY DRUG AND THEN THE STENT WAS EXCRETED WITH THE FECES AFTER 12 HOURS. THREE DAYS LATER, THE PATIENT'S SCR ROSE TO 432.7 MICRO MOL/L, AND URETEROSCOPY WAS UNSUCCESSFUL BECAUSE THE NORMAL URETERAL LUMEN COULD NOT BE SEEN, A PERCUTANEOUS NEPHROSTOMY HAD TO BE PERFORMED UNDER ULTRASOUND GUIDANCE. THE PATIENT LATER PRESENTED WITH ABDOMINAL PAIN, INTRA-ABDOMINAL INFECTION, AND A POSSIBLE URETERO-ILEAL FISTULA. ANTEGRADE PYELOGRAM SHOWED THE PASSAGE OF CONTRAST MEDIA BEYOND THE URETEROPELVIC TRACT TO THE ILEUM. THERAPEUTIC PROCESSES (ANTI-INFECTION, FASTING, AND NUTRITIONAL SUPPORT) WERE ADOPTED FOR A MONTH, HOWEVER, THE PATIENT DIED DUE TO A SEPTIC SHOCK. THE ARTICLE DISCUSSION STATES, THAT IN OUR PATIENT, THE SURGEON MIGHT HAVE DIFFICULTY PLACING THE ZEBRA GUIDEWIRE DUE TO URETERAL TWISTING AND FRAGILE URETERAL MUCOSA. IN OUR CASE, THE ZEBRA GUIDEWIRE POSSIBLY PENETRATED DIRECTLY OUT OF THE UPPER PART OF THE URETER AND THEN INTO THE ADJACENT ILEUM, EVENTUALLY LEADING TO THE DOUBLE-J STENT MISGUIDED INTO THE ILEUM. A COMPUTED TOMOGRAPHY (CT) SCAN OF THE ABDOMEN AND PELVIS SHOWS THE DOUBLE-J STENT WAS MISGUIDED. A CORONAL REFORMAT SHOWS THE END OF THE DOUBLE-J STENT (WHITE ARROWHEADS) LOCATED IN THE TERMINAL ILEUM. TRANSVERSE REFORMAT SHOWS THAT THE STENT WAS AN APPROXIMATE 4MM, HYPERECHOIC, LINEAR INTRALUMINAL STRUCTURE (WHITE ARROWHEADS). ALSO, 3D-CT SHOWS A CONTINUOUS COMPLETE D-J STENT LOCATED IN THE PELVIS (WHITE ARROWHEADS). ANTEGRADE PYELOGRAM THROUGH THE RIGHT NEPHROSTOMY TUBES SHOWED THE PASSAGE OF CONTRAST MEDIA BEYOND THE URETEROPELVIC TRACT TO THE ILEUM (WHITE ARROWHEADS). CT SCAN OF THE PELVIS SHOWS INTRA-ABDOMINAL STRUCTURE DISORDER AND INDISTINCT (BLACK ARROWHEADS), INCLUDING OBSTRUCTION, DILATION (WHITE ARROWHEADS), AND INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111361 PERCUFLEX PLUS CATHETER, BILIARY, DIAGNOSTIC FAD BOSTON SCIENTIFIC CORPORATION M0061752530 08714729056812

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention