BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER

    MDR report key: 21502022 · Received March 3, 2025

    Report

    Report Number
    2029046-2025-00635
    Event Type
    Injury
    Date Received
    March 3, 2025
    Date of Event
    February 4, 2025
    Report Date
    March 3, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OBJ
    UDI-DI
    10846835008845
    PMA / PMN Number
    K112050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. MANUFACTURER RECORD EVALUATION CANNOT BE CONDUCTED BECAUSE THE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER, INC. OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH A SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER AND THE PATIENT EXPERIENCED PSEUDOANEURYSM THAT REQUIRED SURGICAL INTERVENTION. AFTER AN ATRIAL FIBRILLATION CASE, A PSEUDOANEURYSM WAS NOTICED. THE SCRUB TECH NOTICED THE PATIENT WAS BLEEDING FROM THE ACCESS POINT. THE PHYSICIAN INSPECTED THE ACCESS POINT AND DETERMINED THE INJURY WAS A PSEUDOANEURYSM. THE PATIENT WAS BEING SENT TO SURGERY FOR MEDICAL INTERVENTION. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE MEDICAL TEAM BELIEVED THE INJURY WAS A RESULT OF GETTING INTRACARDIAC ECHO (ICE) CATHETER ACCESS IN THE VEIN. THE PHYSICIAN BELIEVES THEY HIT AN ARTERY INSTEAD OF A VEIN WHILE ATTEMPTING TO GAIN VENOUS ACCESS. PHYSICIAN THINKS IT WAS PATIENT ANATOMY AND NOTHING TO DO WITH BWI PRODUCTS. OTHER RELEVANT MEDICAL HISTORY INCLUDES PREVIOUS GRAFT PLACED THAT MAY HAVE BEEN RUPTURED DURING ACCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634454 SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BIOSENSE WEBSTER INC 10846835008845

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R PFA FARAPULSE SYSTEM.