BEUDAMED
    FDA Adverse Event Other Summary report: N

    SWARTZ SL0

    MDR report key: 18028700 · Received October 27, 2023

    Report

    Report Number
    MW5147372
    Event Type
    Other
    Date Received
    October 27, 2023
    Report Date
    October 16, 2023
    Manufacturer
    ST. JUDE MEDICAL, ATRIAL FIBRILLATION DIVISION, INC.
    Product Code
    DYB
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    TRANSSEPTAL PUNCTURE WAS PERFORMED USING THE SWARTZ SL0 AND RF NEEDLE. AFTER THE SWARTZ WAS PLACED IN THE LEFT ATRIUM AND WHILE LEFT ATRIAL IMAGING WAS CONDUCTED, THE ENTIRE LEFT ATRIUM WAS ¿RE-EXPLANTED¿ BY PULLING THE SWARTZ FORWARD. CONTRAST IMAGING REVEALED THAT THE CONTRAST AGENT LEAKED OUT INTO THE ATRIAL SEPTUM. THE PHYSICIAN THINKS THAT THE TIP OF THE SWARTZ WAS ABLE TO BE DRAWN TO THE SEPTUM, AND THAT THE CONTRAST IMAGING PERFORMED THERE MIGHT HAVE CAUSED A DEVIATION DUE TO THE PRESSURE. NO CHANGES WERE OBSERVED IN THE VITALS, BUT THE PROCEDURE WAS DISCONTINUED AT THE PHYSICIAN¿S DISCRETION. THE PATIENT WAS NOT UNDER GENERAL ANESTHESIA. REFERENCE REPORT: MW5147373. 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
    2092194 SWARTZ SL0 INTRODUCER, CATHETER DYB ST. JUDE MEDICAL, ATRIAL FIBRILLATION DIVISION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown RF NEEDLE.