BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFESEPTTM TRANSSEPTAL NEEDLE

    MDR report key: 20409160 · Received October 8, 2024

    Report

    Report Number
    MW5160883
    Event Type
    Injury
    Date Received
    October 8, 2024
    Date of Event
    September 23, 2024
    Report Date
    October 7, 2024
    Manufacturer
    PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC.
    Product Code
    DRC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER INSERTING THE SOUNDSTAR CATHETER INTO THE RIGHT ATRIUM, IT WAS NOTICED THAT THE ICE IMAGE QUALITY WAS POOR, ON THE CARTO 3 AND ULTRASOUND SYSTEM. THE CALLER NOTED THAT THE ICE IMAGE WAS VERY "DARK," AND THEY WERE UNABLE TO DISCERN ANY HEART STRUCTURES. THE CALLER ADJUSTED THE ULTRASOUND SYSTEM AND THE CARTOSOUND INTERFACE SETTINGS, WITHOUT RESOLUTION. THE SOUNDSTAR CATHETER WAS REPLACED AND THE ISSUE RESOLVED. THE PROCEDURE CONTINUED. THE CALLER IS REQUESTING A REPLACEMENT SOUNDSTAR CATHETER. THE CALLER STATED THE SOUNDSTAR CATHETER IS AVAILABLE FOR RETURN. RETURN KIT REQUESTED. THE CALLER NOTED THAT AN NGEN GENERATOR WAS IN USE. THE CALLER CALLED BACK AND REPORTED THAT LATER IN THE PROCEDURE WHEN PERFORMING A TRANS-SEPTAL PUNCTURE THEY PUNCTURED THE AORTIC ROOT WITH A "SAFESEP" TRANSEPTAL NEEDLE (NON BWI PRODUCT). THIS WAS CONFIRMED BY X-RAY. AND WITH THE SOUNDSTAR CATHETER. THERE WAS NO PRESSURE DROP OR SIGNS OF A PERICARDIAL EFFUSION. THE PATIENT WAS THEN TAKEN TO THE OPERATING ROOM FOR SURGICAL REPAIR. "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
    312423 SAFESEPTTM TRANSSEPTAL NEEDLE TROCAR DRC PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown