BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSSEPTAL NEEDLE

    MDR report key: 21478592 · Received February 27, 2025

    Report

    Report Number
    MW5166915
    Event Type
    Injury
    Date Received
    February 27, 2025
    Date of Event
    February 11, 2025
    Report Date
    February 25, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORP. / BAYLIS MEDICAL CORP.
    Product Code
    DXF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    DURING A VENTRICULAR TACHYCARDIA PROCEDURE, A PERICARDIAL EFFUSION OCCURRED REQUIRING A PERICARDIOCENTESIS. MAPPING WAS PERFORMED IN THE RIGHT VENTRICLE UNDER CONSCIOUS SEDATION. THE CATHETER WAS REMOVED AND TRANSSEPTAL ACCESS WAS GAINED. WHILE ATTEMPTING TO GAIN TRANSSEPTAL ACCESS, THE PATIENT MOVED ABRUPTLY. THE (B)(6) (BAYLIS) TRANSSEPTAL NEEDLE SLID DOWN THE SEPTUM AND WAS REPOSITIONED. THE PATIENT WAS THEN PUT UNDER GENERAL ANESTHESIA. TRANSSEPTAL ACCESS WAS GAINED, AND THE MAPPING CATHETER WAS INTRODUCED INTO THE LEFT VENTRICLE. MAPPING WAS BEING PERFORMED BUT AN EFFUSION WAS OBSERVED ON ICE(INTRACARDIAC ECHOCARDIAGRAPHY) IN THE RIGHT VENTRICLE. THE CATHETERS WERE REMOVED TO OBSERVE THE EFFUSION. THE PATIENT BECAME HYPOTENSIVE AND A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THE PHYSICIAN ALLEGES THE EFFUSION OCCURRED WHEN THE PATIENT JUMPED WHILE TRANSSEPTAL PUNCTURE WAS BEING PERFORMED WITH THE (B)(6) (BAYLIS) NEEDLE. THERE WERE NO PERFORMANCE ISSUES WITH ANY (B)(6) DEVICE. THE MAPPING CATHETER WAS DISCARDED. 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
    617688 TRANSSEPTAL NEEDLE CATHETER, SEPTOSTOMY DXF BOSTON SCIENTIFIC CORP. / BAYLIS MEDICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown