BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSACROSS SHEATH

    MDR report key: 23726841 · Received December 4, 2025

    Report

    Report Number
    MW5179960
    Event Type
    Injury
    Date Received
    December 4, 2025
    Date of Event
    October 27, 2025
    Report Date
    December 2, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FKO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CALLER THAT AN ADVERSE EVENT OCCURRED. THE CALLER NOTED THAT THE STERILMED ULTRASOUND CATHETER WAS INSERTED INTO THE PATIENT. THE CALLER NOTED THAT THE VERACROSS SHEATH WAS THEN INSERTED INTO THE PATIENT. THE CALLER STATED THAT THE PHYSICIAN THEN ATTEMPTED TO GO TRANSSEPTAL. IT WAS THEN THAT THE PATIENT'S BLOOD PRESSURE BEGAN TO DROP. THE PHYSICIAN UTILIZED THE ULTRASOUND CATHETER TO VIEW THE PERICARDIAL SPACE. THE CALLER NOTED THAT A PERICARDIAL EFFUSION WAS NOTICED. THE PHYSICIAN PERFORMED A PERICARDIOCENTESIS. THE CALLER STATED THAT THE PATIENT WAS IN STABLE CONDITION. THE CALLER WAS UNABLE TO PROVIDE ADDITIONAL EVENT DETAILS. THE CALLER WAS UNABLE TO PROVIDE THE ULTRASOUND CATHETER CATALOG/REFERENCE OR LOT NUMBERS. THE CALLER NOTED THAT THE STERILMED CATHETER AND THE VERACROSS SHEATH WERE THE ONLY DEVICES IN THE PATIENT AT THE TIME OF THE EVENT. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2454661 VERSACROSS SHEATH CATHETER, PERITONEAL DIALYSIS, SINGLE USE FKO BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown