BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCUFLEX URETERAL STENT

    MDR report key: 18708299 · Received February 14, 2024

    Report

    Report Number
    2124215-2024-08380
    Event Type
    Injury
    Date Received
    February 14, 2024
    Date of Event
    February 1, 2008
    Report Date
    March 19, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 E1: INITIAL REPORTER FACILITY NAME: (B)(6). BLOCK G2 (REPORT SOURCE): JOURNAL ARTICLE: SU HO KIM., ET AL 'UPPER TRACT HEPARIN INSTILLATION FOR MAINTENANCE OF URETERAL STENT PATENCY'. INTERNATIONAL UROLOGY NEPHROLOGY (2023) 55:1893-1897. BLOCK H6: IMDRF DEVICE CODE A1409 CAPTURES THE REPORTABLE EVENT OF DEVICE OCCLUSION. IMDRF PATIENT CODE E0505 CAPTURES THE REPORTABLE EVENT OF HEMATOMA. IMDRF IMPACT CODE F12 CAPTURES THE REPORTABLE EVENT OF SERIOUS INJURY BLOCK H11: CORRECTION TO G1: MFR SITE ADDRESS. CORRECTION TO FIELD G2: REPORT SOURCE. CORRECTION TO FIELD H6: IMPACT CODE.

    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 E1: (B)(6). BLOCK G2 (REPORT SOURCE): JOURNAL ARTICLE: SU HO KIM, ET AL 'UPPER TRACT HEPARIN INSTILLATION FOR MAINTENANCE OF URETERAL STENT PATENCY'. INTERNATIONAL UROLOGY NEPHROLOGY (2023) 55:1893-1897. BLOCK H6: IMDRF DEVICE CODE A1409 CAPTURES THE REPORTABLE EVENT OF DEVICE OCCLUSION. IMDRF PATIENT CODE E0505 CAPTURES THE REPORTABLE EVENT OF HEMATOMA.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF THE EVENT THROUGH THE ARTICLE, 'UPPER TRACT HEPARIN INSTILLATION FOR MAINTENANCE OF URETERAL STENT PATENCY' SU HO KIM, BYUNG GIL CHOI, JUNG SUK OH, HO JONG CHUN. PER THE ARTICLE, THE STUDY AIMED TO EVALUATE THE EFFICACY OF HEPARIN PACKING AFTER ANTEGRADE URETERAL STENT PLACEMENT IN THE RENAL PELVIS TO PROTECT AGAINST EARLY DYSFUNCTION. FROM DECEMBER 2019 TO SEPTEMBER 2021, 44 DOUBLE J (DJ) STENT PLACEMENTS WERE PERFORMED WITH HEPARIN PACKING (HEPARIN PACKING GROUP). BETWEEN FEBRUARY 2008 AND MARCH 2014, 250 DJ STENT PLACEMENTS WITHOUT HEPARIN PACKING WERE PERFORMED (CONTROL GROUP). ONE-WEEK PATENCY AND 3-MONTH PATENCY OF THE TWO GROUPS WERE COMPARED. THE PATENCY OF THE DJ STENT ACCORDING TO THE BLOOD RETENTION GRADE IN THE URINARY SYSTEM WAS ALSO COMPARED BY SUBGROUP ANALYSIS. A DJ STENT PERCUFLEX; 7F, 23 OR 26 CM IN LENGTH WAS THEN INSERTED OVER A WIRE. AN ANTEGRADE PYELOGRAM WAS PERFORMED THROUGH A SAFETY CATHETER TO CONFIRM THE PATENCY OF THE DJ STENT AND THE GRADE OF BLOOD CLOTS IN THE URINARY SYSTEM. AFTERWARDS, 1000 IU OF HEPARIN AND 8 CC OF SALINE WERE INJECTED THROUGH THE SAFETY CATHETER AND THE CATHETER WAS CLOSED. BLOOD CLOT GRADE 2 WAS OBSERVED IN THE RENAL PELVIS ON PYELOGRAPHY AFTER INSERTION OF THE DJ STENT WITH HEPARIN PACKING. ON PYELOGRAPHY PERFORMED TWO DAYS LATER, THE BLOOD CLOT HAD DISAPPEARED, THE PATENCY OF THE URETERAL STENT WAS CONFIRMED, AND THE SAFETY CATHETER WAS REMOVED. BLOOD CLOTS IN THE URINARY SYSTEM WERE CONFIRMED THROUGH AN ANTEGRADE PYELOGRAM PERFORMED IMMEDIATELY AFTER DJ STENT PLACEMENT AND CLASSIFIED ON A TWO-POINT SCALE. GRADE 1, NO BLOOD CLOT OR MINIMAL BLOOD CLOT IN THE CALYCES OR INFUNDIBULUM; GRADE 2, BLOOD CLOT IN THE PELVIS OR URETER 1-WEEK PATENCY WAS DEFINED AS THE ABSENCE OF DYSFUNCTION OF THE URETERAL STENT IN THE ANTEGRADE PYELOGRAM THROUGH A SAFETY CATHETER WITHIN 1 WEEK AFTER THE PROCEDURE. THREE-MONTH (TIME POINT FOR A FIRST DJ STENT CHANGE) PATENCY WAS DEFINED AS A CASE IN WHICH NO SIGNS OR SYMPTOMS DUE TO DJ STENT DYSFUNCTION SUCH AS DECREASED URINE OUTPUT, INCREASED CREATININE, OR AGGRAVATED HYDRONEPHROSIS OCCURRED FOR 3 MONTHS AFTER THE PROCEDURE. ADDITIONALLY, THE STENT PATENCY OF PATIENTS WITH BENIGN AND MALIGNANT CONDITIONS IN EACH GROUP WAS COMPARED. AS A RESULT, THE 1-WEEK PATENCY RATE IN THE HEPARIN PACKING GROUP WAS SIGNIFICANTLY HIGHER COMPARED TO THE CONTROL GROUP (88.6% AND 65.2%, RESPECTIVELY, P= 0.002). THERE WAS NO SIGNIFICANT DIFFERENCE IN THE 3-MONTH PATENCY RATE BETWEEN THE TWO GROUPS (72.7% AND 60.9%, RESPECTIVELY; P= 0.187). IN THE SUBGROUP ANALYSIS, AMONG THE PATIENTS WITH HIGH BLOOD RETENTION GRADES, THE 1-WEEK PATENCY RATES OF THE HEPARIN PACKING GROUP WERE SIGNIFICANTLY HIGHER THAN THAT OF THE CONTROL GROUP (100% AND 60.9%, RESPECTIVELY; P< 0.001). THERE WERE NO MAJOR COMPLICATIONS SUCH AS PERSISTENT ARTERIAL BLEEDING WHICH REQUIRE EMBOLIZATION IN THE HEPARIN PACKING GROUP. SEVEN CASES IN THE CONTROL GROUP EXHIBITED MASSIVE BLEEDING. AFTER EMBOLIZATION, ALL THE PATIENTS IMPROVED. IN CONCLUSION, HEPARIN PACKING THROUGH THE CATHETER AFTER DJ STENT INSTALLATION AIDS IN DJ STENT PATENCY.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF THE EVENT THROUGH THE ARTICLE, 'UPPER TRACT HEPARIN INSTILLATION FOR MAINTENANCE OF URETERAL STENT PATENCY'. SU HO KIM, BYUNG GIL CHOI, JUNG SUK OH, HO JONG CHUN. PER THE ARTICLE, THE STUDY AIMED TO EVALUATE THE EFFICACY OF HEPARIN PACKING AFTER ANTEGRADE URETERAL STENT PLACEMENT IN THE RENAL PELVIS TO PROTECT AGAINST EARLY DYSFUNCTION. FROM DECEMBER 2019 TO SEPTEMBER 2021, 44 DOUBLE J (DJ) STENT PLACEMENTS WERE PERFORMED WITH HEPARIN PACKING (HEPARIN PACKING GROUP). BETWEEN FEBRUARY 2008 AND MARCH 2014, 250 DJ STENT PLACEMENTS WITHOUT HEPARIN PACKING WERE PERFORMED (CONTROL GROUP). ONE-WEEK PATENCY AND 3-MONTH PATENCY OF THE TWO GROUPS WERE COMPARED. THE PATENCY OF THE DJ STENT ACCORDING TO THE BLOOD RETENTION GRADE IN THE URINARY SYSTEM WAS ALSO COMPARED BY SUBGROUP ANALYSIS. A DJ STENT PERCUFLEX; 7F, 23 OR 26 CM IN LENGTH WAS THEN INSERTED OVER A WIRE. AN ANTEGRADE PYELOGRAM WAS PERFORMED THROUGH A SAFETY CATHETER TO CONFIRM THE PATENCY OF THE DJ STENT AND THE GRADE OF BLOOD CLOTS IN THE URINARY SYSTEM. AFTERWARDS, 1000 IU OF HEPARIN AND 8 CC OF SALINE WERE INJECTED THROUGH THE SAFETY CATHETER AND THE CATHETER WAS CLOSED. BLOOD CLOT GRADE 2 WAS OBSERVED IN THE RENAL PELVIS ON PYELOGRAPHY AFTER INSERTION OF THE DJ STENT WITH HEPARIN PACKING. ON PYELOGRAPHY PERFORMED TWO DAYS LATER, THE BLOOD CLOT HAD DISAPPEARED, THE PATENCY OF THE URETERAL STENT WAS CONFIRMED, AND THE SAFETY CATHETER WAS REMOVED. BLOOD CLOTS IN THE URINARY SYSTEM WERE CONFIRMED THROUGH AN ANTEGRADE PYELOGRAM PERFORMED IMMEDIATELY AFTER DJ STENT PLACEMENT AND CLASSIFIED ON A TWO-POINT SCALE. GRADE 1, NO BLOOD CLOT OR MINIMAL BLOOD CLOT IN THE CALYCES OR INFUNDIBULUM; GRADE 2, BLOOD CLOT IN THE PELVIS OR URETER 1-WEEK PATENCY WAS DEFINED AS THE ABSENCE OF DYSFUNCTION OF THE URETERAL STENT IN THE ANTEGRADE PYELOGRAM THROUGH A SAFETY CATHETER WITHIN 1 WEEK AFTER THE PROCEDURE. THREE-MONTH (TIME POINT FOR A FIRST DJ STENT CHANGE) PATENCY WAS DEFINED AS A CASE IN WHICH NO SIGNS OR SYMPTOMS DUE TO DJ STENT DYSFUNCTION SUCH AS DECREASED URINE OUTPUT, INCREASED CREATININE, OR AGGRAVATED HYDRONEPHROSIS OCCURRED FOR 3 MONTHS AFTER THE PROCEDURE. ADDITIONALLY, THE STENT PATENCY OF PATIENTS WITH BENIGN AND MALIGNANT CONDITIONS IN EACH GROUP WAS COMPARED. AS A RESULT, THE 1-WEEK PATENCY RATE IN THE HEPARIN PACKING GROUP WAS SIGNIFICANTLY HIGHER COMPARED TO THE CONTROL GROUP (88.6% AND 65.2%, RESPECTIVELY, P= 0.002). THERE WAS NO SIGNIFICANT DIFFERENCE IN THE 3-MONTH PATENCY RATE BETWEEN THE TWO GROUPS (72.7% AND 60.9%, RESPECTIVELY; P= 0.187). IN THE SUBGROUP ANALYSIS, AMONG THE PATIENTS WITH HIGH BLOOD RETENTION GRADES, THE 1-WEEK PATENCY RATES OF THE HEPARIN PACKING GROUP WERE SIGNIFICANTLY HIGHER THAN THAT OF THE CONTROL GROUP (100% AND 60.9%, RESPECTIVELY; P< 0.001). THERE WERE NO MAJOR COMPLICATIONS SUCH AS PERSISTENT ARTERIAL BLEEDING WHICH REQUIRE EMBOLIZATION IN THE HEPARIN PACKING GROUP. SEVEN CASES IN THE CONTROL GROUP EXHIBITED MASSIVE BLEEDING. AFTER EMBOLIZATION, ALL THE PATIENTS IMPROVED. IN CONCLUSION, HEPARIN PACKING THROUGH THE CATHETER AFTER DJ STENT INSTALLATION AIDS IN DJ STENT PATENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781238 PERCUFLEX URETERAL STENT CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Unknown Required Intervention