BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCUFLEX PLUS

    MDR report key: 19779685 · Received July 18, 2024

    Report

    Report Number
    2124215-2024-43594
    Event Type
    Injury
    Date Received
    July 18, 2024
    Date of Event
    June 26, 2024
    Report Date
    October 7, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FAD
    UDI-DI
    08714729067757
    PMA / PMN Number
    K924608
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: PROBLEM DEVICE CODE A040501 CAPTURES THE REPORTABLE EVENT OF STENT CALCIFIED. IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL DEVICE REQUIRED.

    Additional Manufacturer Narrative · 0

    BLOCK H6: PROBLEM DEVICE CODE A040501 CAPTURES THE REPORTABLE EVENT OF STENT CALCIFIED. IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL DEVICE REQUIRED.

    Additional Manufacturer Narrative · 0

    BLOCK H6: PROBLEM DEVICE CODE A040501 CAPTURES THE REPORTABLE EVENT OF STENT CALCIFIED. IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL DEVICE REQUIRED. BLOCK H11: CORRECTION TO FIELD BLOCK B5: DESCRIBE EVENT OR PROBLEM. CORRECTION TO FIELD: INITIAL REPORTER PHONE, INITIAL REPORTER ADDRESS 1, AND INITIAL REPORTER ADDRESS 2.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A TRANSURETHRAL LITHOTOMY PROCEDURE, A PERCUFLEX PLUS URETERAL STENT WAS SUCCESSFULLY IMPLANTED ON (B)(6) 2024. ON (B)(6) 2024, IT WAS FOUND THAT THE STENT WAS ENCRUSTED, AND IT WAS REMOVED FROM THE PATIENT. ANOTHER OF THE SAME STENT WAS USED TO REPLACE THE ENCRUSTED STENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A TRANSURETHRAL LITHOTOMY PROCEDURE, A PERCUFLEX PLUS URETERAL STENT WAS SUCCESSFULLY IMPLANTED ON (B)(6) 2024. ON (B)(6) 2024, IT WAS FOUND THAT THE STENT WAS ENCRUSTED, AND IT WAS REMOVED FROM THE PATIENT. ANOTHER OF THE SAME STENT WAS USED TO REPLACE THE ENCRUSTED STENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A TRANSURETHRAL LITHOTOMY PROCEDURE, A PERCUFLEX PLUS URETERAL STENT WAS SUCCESSFULLY IMPLANTED ON (B)(6) 2024. AFTER 28 DAYS, IT WAS DETERMINED THAT THE STENT WAS ENCRUSTED. ON (B)(6) 2024, THE STENT WAS REMOVED FROM THE PATIENT USING A GRASPER. ANOTHER OF THE SAME STENT WAS USED TO REPLACE THE ENCRUSTED STENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1918620 PERCUFLEX PLUS CATHETER, BILIARY, DIAGNOSTIC FAD BOSTON SCIENTIFIC CORPORATION M0061752540 0030270604 08714729067757

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention