BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NBRK TRANSSEPTAL NEEDLE, BRK-1 XS

    MDR report key: 2960824 · Received February 11, 2013

    Report

    Report Number
    3005188751-2013-00023
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC. (AF-MINNETONKA)
    Product Code
    DRC
    PMA / PMN Number
    K072278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. THE ROOT CAUSE CLASSIFICATION OF THE REPORTED CARDIAC TAMPONADE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE IFU.

    Description of Event or Problem · 1

    A CARDIAC TAMPONADE OCCURRED DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE USING ENSITE VELOCITY WITH NAVX PATCHES FOR MAPPING AND A HENSEN ARTISAN CONTROL CATHETER. A NON-SJM BIDIRECTIONAL OCTAPOLAR CATHETER WAS PLACED IN THE CORONARY SINUS. ONE TRANSSEPTAL PUNCTURE WAS PERFORMED USING AN AGILIS INTRODUCER AND A BRK-1 XS TRANSSEPTAL NEEDLE. THE NEEDLE AND INTRODUCER WITH THE DILATOR WERE ADVANCED TO THE RIGHT ATRIUM AND POSITIONED AT THE FORAMEN OVALE. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE AGILIS ACROSS THE SEPTUM OVER THE DILATOR; HOWEVER, HE COULD NOT GET THE INTRODUCER ACROSS DUE TO PATIENT ANATOMY. THE PHYSICIAN USED CAUTERY WITH THE BRK NEEDLE TO ADVANCE THE AGILIS ACROSS THE SEPTUM. AN AFOCUS II DIAGNOSTIC CATHETER WAS ADVANCED THROUGH THE AGILIS AND USED TO CREATE LEFT ATRIAL GEOMETRY. AFTER GEOMETRY COLLECTION, THE AGILIS WAS PULLED BACK INTO THE RIGHT ATRIUM AND THE HANSEN ARTISAN CONTROL CATHETER WAS USED TO ADVANCE A NON-SJM CATHETER ACROSS THE SEPTUM. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE AGILIS BACK ACROSS THE SEPTUM. AT THIS TIME, A CARDIAC TAMPONADE WAS FOUND. THIS WAS DIAGNOSED WITH A NON-SJM ICE CATHETER. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT PROCEEDED TO THE OPERATING ROOM FOR EXPLORATORY CARDIAC SURGERY. A CARDIAC PERFORATION WAS FOUND BY THE ATRIOVENTRICULAR GROOVE NEAR THE BASE OF THE LEFT ATRIAL APPENDAGE. THE TREATMENT USED FOR THE PERFORATION DURING THE SURGERY IS NOT KNOWN. THE PATIENT WAS STABLE FOLLOWING SURGERY. THE PHYSICIAN INDICATED THAT THE PERFORATION OCCURRED AS A RESULT OF THE TRANSSEPTAL PUNCTURE WITH THE BRK NEEDLE WHEN TRYING TO ADVANCE THE AGILIS ACROSS THE SEPTUM BUT DOES NOT NOTE ANY PERFORMANCE ISSUES WITH ANY SJM DEVICES USED FOR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59388 NBRK TRANSSEPTAL NEEDLE, BRK-1 XS TRANSSEPTAL NEEDLE DRC ST. JUDE MEDICAL, INC. (AF-MINNETONKA) G407212 3872140

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention BARD BIDIRECTIONAL STEERO-CATH| (MODEL 87008/LOT 3725229)| HANSEN ARTISAN SHEATH| AFOCUS II DIAGNOSTIC CATHETER:| BIOSENSE WEBSTER THERMOCOOL EZ STEER CATHETER| VELOCITY SYSTEM| NAVX