BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFIRE BLU DUO

    MDR report key: 2850678 · Received November 20, 2012

    Report

    Report Number
    2030404-2012-00294
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    April 8, 2012
    Report Date
    October 26, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC. (AF-IRVINE)
    Product Code
    OAD
    PMA / PMN Number
    P110016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE WERE UNABLE TO EVALUATE THE PRODUCT INVOLVED IN THIS INCIDENT SINCE NO COMPONENTS OF THE DEVICE WERE RETURNED FOR ANALYSIS. A DHR REVIEW COULD NOT BE DONE, AS THE LOT NUMBER WAS NOT PROVIDED. IF THE DEVICE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED. THE ROOT CAUSE CLASSIFICATION FOR THE REPORTED PULMONARY VEIN STENOSIS IS ANTICIPATED PROCEDURAL COMPLICATIONS, AS THIS IS A CLINICALLY KNOWN COMPLICATION OF RADIOFREQUENCY ABLATION PROCEDURES PERFORMED ON OR AROUND THE PULMONARY VEINS.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A PATIENT FOLLOW UP EXAMINATION AFTER A REPEAT ATRIAL FIBRILLATION ABLATION PROCEDURE PERFORMED WITH A SAFIRE BLU DUO ABLATION CATHETER AND A NON-SJM GENERATOR COMPLETED ON (B)(6) 2012, THE PATIENT'S SYMPTOMS AND ECHOCARDIOGRAM SUGGESTED PULMONARY VEIN STENOSIS. PRIOR TO THE INITIAL ABLATION PROCEDURE, THE PATIENT HAD A CT SCAN, WHICH WAS SEGMENTED WITH VERISMO AND USED DURING THE PROCEDURE; HOWEVER, THIS CT SCAN, IN WHICH NO STENOSIS WAS NOTED, WAS DONE PRIOR TO THE PATIENT'S INITIAL ATRIAL FIBRILLATION ABLATION PROCEDURE, COMPLETED (B)(6) 2011. ADDITIONAL VISUALIZATION DURING THE PROCEDURE WAS DONE VIA INTRACARDIAC ECHOCARDIOGRAPHY. NO ANGIOGRAPHY OF THE PULMONARY VEINS WAS PERFORMED. THERE WERE NO ISSUES OR COMPLICATIONS DURING THE PROCEDURE ITSELF. AT A FOLLOW UP WITH THE PHYSICIAN, THE PATIENT COMPLAINED OF SHORTNESS OF BREATH WHICH PROMPTED FURTHER EVALUATION. A SUBSEQUENT CT SCAN CONFIRMED STENOSIS OF ALL FOUR PULMONARY VEINS. THE PATIENT WAS REFERRED FOR FURTHER TREATMENT, WHICH INCLUDED STENT PLACEMENT IN ALL FOUR VEINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFIRE BLU DUO CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL, INC. (AF-IRVINE) A088109

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention ENSITE NAVX| REFLEXION SPIRAL X| STEERABLE DECA CATHETER (LIKELY REPROCESSED)| ACUNAV ICE| AGILIS INTRODUCER| STOCKERT GENERATOR