BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAYLIS TRANSSEPTAL NEEDLE

    MDR report key: 21953116 · Received May 2, 2025

    Report

    Report Number
    MW5169895
    Event Type
    Injury
    Date Received
    May 2, 2025
    Date of Event
    April 7, 2025
    Report Date
    April 30, 2025
    Manufacturer
    BAYLIS MEDICAL CORP.
    Product Code
    DXF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CLINICAL ACCOUNT SPECIALIST THAT DURING AN LAAO CASE, A TRANSSEPTAL PUNCTURE OF THE AORTA OCCURRED. THE CALLER STATED THE INJURY OCCURRED WHILE GOING TRANSEPTAL FOR A LEFT ATRIAL APPENDAGE CLOSER. THE CALLER STATED THE LOCATION OF THE TRANSEPTAL WIRE LED TO THE DISCOVERY OF THIS EVENT. THE CALLER STATED THE INJURY WAS CONFIRMED WITH TEE, ICE AND THE PRESSURE WAVE FORM. THE CALLER STATED THEY REVERSED THE HEPARIN AND PULLED THE TRANSEPTAL WIRE FROM THE BODY. THE CALLER STATED THE ONLY (B)(6) PRODUCT THAT WAS IN THE BODY DURING THE PROCEDURE WAS A SOUNDSTAR ICE CATHETER. THE CALLER STATED THE CATHETER USED DURING THE PROCEDURE WAS DISPOSED OF AND IS NOT AVAILABLE FOR RETURN. THE CALLER STATED THE PATIENT HAD NO COMPLICATIONS AND LEFT THE LAB IN STABLE CONDITION. THE CALLER STATED THERE WAS NO GENERATOR USED DURING THE PROCEDURE. THE CALLER STATED IT WAS UNKNOWN WHAT HAD CAUSED THE INJURY. THE CALLER STATED THE THAT AN S70 GE ULTRASOUND MACHINE WAS USED DURING THE PROCEDURE. THE CALLER STATED THE CARTO 3 SYSTEM WAS NOT USED DURING THE PROCEDURE. THE CALLER STATED THE CATHETER USED DURING THE PROCEDURE WAS HOOKED UP TO THE CARTO 3 SYSTEM JUST FOR THE IMAGE. 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
    2102336 BAYLIS TRANSSEPTAL NEEDLE CATHETER, SEPTOSTOMY DXF BAYLIS MEDICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown