BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRK

    MDR report key: 17525016 · Received August 12, 2023

    Report

    Report Number
    MW5131958
    Event Type
    Injury
    Date Received
    August 12, 2023
    Date of Event
    March 29, 2018
    Report Date
    April 25, 2018
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    NMK
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN AFIB CASE, A PERICARDIAL EFFUSION WAS NOTICED AS THE PATIENT'S BLOOD PRESSURE DROPPED. THE PERICARDIAL EFFUSION WAS CONFIRMED BY ECHO. CALLER REPORTED THAT THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND 700CC OF FLUID WAS REMOVED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. ADDITIONAL INFORMATION WAS RECEIVED ON 04/03/2018: PHYSICIAN'S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED, AS THE INJURY OCCURRED DURING THE REPEAT TRANSSEPTAL PUNCTURE. TRANSSEPTAL PUNCTURE WAS PERFORMED X2 WITH A(B)(6) BRK TRANSSEPTAL NEEDLE. SHEATH USED WAS (B)(6) SL2 FRENCH. (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
    764152 BRK TROCAR, REPROCESSED NMK ST. JUDE MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown