BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST. JUDE MEDICAL SL0-TRANSSEPTAL NEEDLE

    MDR report key: 17526727 · Received August 12, 2023

    Report

    Report Number
    MW5133665
    Event Type
    Injury
    Date Received
    August 12, 2023
    Date of Event
    November 12, 2019
    Report Date
    December 4, 2019
    Manufacturer
    ST. JUDE
    Product Code
    DRC
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) PROCEDURE IT WAS NOTED THAT THE PATIENT SUFFERED A PERICARDIAL EFFUSION. THERE WAS NO ISSUE WITH THE BIOSENSE WEBSTER, INC. CARTO 3 SYSTEM AND THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED ON 11/29/2019, AND IT WAS REPORTED THE COMPLAINT WAS REPORTED TO BIOSENSE WEBSTER, INC. FOR THE PERICARDIAI EFFUSION. HOWEVER, THE PERICARDIAI EFFUSION WAS NOT CAUSED BY ANY BIOSENSE WEBSTER, INC. DEVICES. IT WAS NOTED THAT THE TRANSSEPTAL PUNCTURE IS WHAT LED TO THE PERICARDIAI EFFUSION. THE TRANSSEPTAL NEEDLE THAT WAS USED WAS A ST. JUDE MEDICAL SL0 TRANSSEPTAL NEEDLE. (B)(4). 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
    2234373 ST. JUDE MEDICAL SL0-TRANSSEPTAL NEEDLE TROCAR DRC ST. JUDE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown