BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSSEPTAL NEEDLE, BRK 1, 71CM

    MDR report key: 2960808 · Received February 11, 2013

    Report

    Report Number
    3005188751-2013-00024
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 15, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC. (AF-MINNETONKA)
    Product Code
    DRC
    PMA / PMN Number
    K072278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE BRK TRANSSEPTAL NEEDLE WITH NO STYLET WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED NO ANOMALIES. THE VALVE MOVED FREELY IN BOTH DIRECTIONS AS INTENDED. MICROSCOPIC INSPECTION OF THE DISTAL SHARPENED TIP REVEALED NO ANOMALIES. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. THE ROOT CAUSE CLASSIFICATION OF THE REPORTED PERICARDIAL EFFUSION IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURES AS NOTED IN IFU.

    Additional Manufacturer Narrative · 1

    ONE BRK TRANSSEPTAL NEEDLE WITH NO STYLET WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED NO ANOMALIES. THE VALVE MOVED FREELY IN BOTH DIRECTIONS AS INTENDED. MICROSCOPIC INSPECTION OF THE DISTAL SHARPENED TIP REVEALED NO ANOMALIES. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. THE ROOT CAUSE CLASSIFICATION OF THE REPORTED PERICARDIAL EFFUSION IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURES AS NOTED IN IFU.

    Description of Event or Problem · 1

    DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE A PERICARDIAL EFFUSION OCCURRED. THE PHYSICIAN PERFORMED TWO TRANSSEPTAL PUNCTURES WITH A BRK TRANSSEPTAL NEEDLE, A SRO INTRODUCER. A NON-SJM ICE CATHETER WAS PLACED IN THE RIGHT ATRIUM AND A LIVEWIRE CATHETER IN THE CORONARY SINUS. A REFLEXION SPIRAL DIAGNOSIS CATHETER AND A COOL PATH ABLATION CATHETER WERE ADVANCED INTO THE LEFT ATRIUM TO CREATE GEOMETRY. ONCE THE GEOMETRY WAS CREATED, THE PHYSICIAN THEN NOTED THAT THE PATIENT BECAME HYPOTENSIVE. THE ICE CATHETER WAS MOVED TO THE RIGHT VENTRICLE, REVEALING A SMALL EFFUSION IN THE PERICARDIAL SPACE. ALL CATHETERS WERE REMOVED AND HEPARIN WAS REVERSED. NO INTERVENTIONS WERE INITIATED FOR THE SMALL EFFUSION AND THE PATIENT WAS STABLE. THE PHYSICIAN DOES NOT ALLEGE ANY PERFORMANCE ISSUES WITH ANY SJM DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60413 TRANSSEPTAL NEEDLE, BRK 1, 71CM TRANSSEPTAL NEEDLE DRC ST. JUDE MEDICAL, INC. (AF-MINNETONKA) 407201 3862923

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other COOL PATH (MODEL 84308/LOT 3809876)| REFLEXION SPIRAL (MODEL D402865/LOT 3863854)| LIVEWIRE (401575/LOT 3813947)| SLO INTRODUCER| SRO INTRODUCER| BIOSENSE WEBSTER ICE CATHETER