BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFIRE BLU DUO, ABLATION CATHETER

    MDR report key: 2822381 · Received November 2, 2012

    Report

    Report Number
    2030404-2012-00283
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 11, 2012
    Manufacturer
    ST. JUDE MEDICAL. (AF-IRVINE)
    Product Code
    OAD
    PMA / PMN Number
    P110016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPONENT DEVICE A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A LEFT VENTRICULAR TACHYCARDIA ABLATION PROCEDURE A PERICARDIAL EFFUSION OCCURRED WHICH REQUIRED A PERICARDIOCENTESIS TO RESOLVE. THE PHYSICIAN INSERTED A SWARTZ BRAIDED INTRODUCER AND RESPONSE EP CATHETER INTO THE RIGHT VENTRICLE AND A SUPREME EP CATHETER INTO THE HIS BUNDLE REGION FOR ANATOMY MARKING. A TRANSSEPTAL PUNCTURE WAS COMPLETED WITH A BRK NEEDLE AND A SAFIRE BLU DUO ABLATION CATHETER WAS PLACED IN THE LEFT VENTRICLE THROUGH AN AGILIS NXT INTRODUCER. THE VELOCITY SYSTEM WAS USED FOR MAPPING. LOW VOLTAGE ABLATION WAS DONE IN THE LEFT VENTRICLE. THE VOLTAGE WAS INCREASED AND AN APPLICATION OF ENERGY WAS DELIVERED TO THE LEFT VENTRICULAR WALL WHEN THE PHYSICIAN NOTICED THE SAFIRE BLU DUO CATHETER 'WENT OFF PLAIN" ON THE VELOCITY MAPPING SYSTEM SCREEN. THE PHYSICIAN ASSESSED THE PT FOR MOVEMENT BUT SHE WAS NOT MOVING. THE PT WENT INTO AN IDIOVENTRICULAR RHYTHM, HER BLOOD PRESSURE DROPPED, AN OXYGEN SATURATION READING COULD NOT BE ESTABLISHED, AND A PULSE COULD NOT BE PALPATED. AN ECHOCARDIOGRAM WAS COMPLETED TO VERIFY A PERICARDIAL EFFUSION. THE PT WAS INTUBATED, CPR WAS STARTED, AND A PERICARDIOCENTESIS WAS PERFORMED TO EVACUATE 650 ML OF BLOOD. THE PTS RHYTHM WAS RESTORED TO SINUS RHYTHM AND AN ECHOCARDIOGRAM FOLLOWING THE PERICARDIOCENTESIS CONFIRMED THE EFFUSION RESOLVED. THE PT WENT TO ICU AND REMAINED IN STABLE CONDITION. THE NEXT MORNING THE PT WAS HEMODYNAMICALLY STABLE BUT REMAINED ON THE VENTILATOR DUE TO HER COPD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFIRE BLU DUO, ABLATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL. (AF-IRVINE) A088107 3774913

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention VELOCITY MAPPING SYSTEM:| SWARTZ BRAIDED INTRODUCER:| BRK NEEDLE: (MODEL 407200, LOT 3785250)| AGILIS NXT INTRODUCER (MODEL G408324, LOT 3633378)| RESPONSE EP CATHETER: (MODEL 401227, LOT 3771397)| SUPREME EP CATHETER: (MODEL 401860, LOT 3710060)| (MODEL 407453, LOT 3770247)