BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRK NEEDLE

    MDR report key: 17524950 · Received August 12, 2023

    Report

    Report Number
    MW5131892
    Event Type
    Injury
    Date Received
    August 12, 2023
    Date of Event
    September 24, 2015
    Report Date
    October 8, 2015
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DRC
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT SUFFERED CARDIAC PERFORATION AS THE ABLATION CATHETER WAS ADVANCED AND, UNINTENTIONALLY, ENTERED THE PERICARDIA SPACE. AFTER ATTEMPTING A DIFFICULT TRANSSEPTAL ACCESS THE PHYSICIAN WITHDREW THE NEEDLE, BELIEVING IT CREATED A CHANNEL. THE PHYSICIAN WAS UNABLE TO ADVANCE THE SMARTTOUCH CATHETER VERY FAR OUT OF THE TRANSSEPTAL SHEATH. THEY WITHDREW THE CATHETER, INJECTED CONTRAST AND VISUALIZED THE CONTRAST INSIDE PERICARDIAI SPACE UNDER FLOURO. THEY PERFORMED A TRANSTHORACIC ECHO WHICH SHOWED PERICARDIAL EFFUSION. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. NO ABLATION HAD YET BEEN PERFORMED, THOUGH A MAP WAS MADE WITH A PENTARAY NAV CATHETER. BWI EQUIPMENT IN USE: C3 SYSTEM 14284 SMARTTOUCH CATHETER: D132705, LOT# 17281043M PL1-W6NTM9. 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
    2177122 BRK NEEDLE TROCAR DRC ST. JUDE MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown