BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOJET? ZELANTEDVT?

    MDR report key: 25243055 · Received May 21, 2026

    Report

    Report Number
    2124215-2026-27424
    Event Type
    Injury
    Date Received
    May 21, 2026
    Date of Event
    April 23, 2026
    Report Date
    May 21, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DXE
    UDI-DI
    08714729904724
    PMA / PMN Number
    K151313
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B - PRO CODE (PRODUCT CODE): DXE, KRA. DETAILED PRODUCT, EVENT AND PATIENT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION, BUT IT WAS UNABLE TO BE OBTAINED. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) AND OTHER SPECIFIC PRODUCT INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WENT INTO RENAL FAILURE POST-PROCEDURE AND HAD TO BE TAKEN TO THE HOSPITAL. AN ANGIOJET ZELANTEDVT WAS SELECTED FOR USE IN A THROMBECTOMY PROCEDURE. THE DEVICE WAS SUCCESSFULLY USED DURING THE PROCEDURE WITHOUT ANY COMPLICATIONS. POST PROCEDURE, IT WAS NOTED THAT THE PATIENT'S CREATININE LEVEL WHICH WAS HIGHLY ELEVATED AND WENT INTO RENAL FAILURE. THE PATIENT WAS TAKEN TO THE HOSPITAL FOR FURTHER TREATMENT AND EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129197 ANGIOJET? ZELANTEDVT? CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC CORPORATION 114610-001 08714729904724

    Patients

    Seq Age Sex Outcome Treatment
    1