BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFIRE BLU, 1304-CPS-7-25-MC-BD

    MDR report key: 2536043 · Received April 6, 2012

    Report

    Report Number
    2030404-2012-00108
    Event Type
    Injury
    Date Received
    April 6, 2012
    Date of Event
    March 15, 2012
    Report Date
    March 15, 2012
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED CATHETER REVEALED NO ANOMALIES. THE CATHETER CREATED CURVE WHEN DEFLECTED, WHICH MATCHED THE REQUIRED TEMPLATE AND THE STEERING FORCE TO CREATE THE CURVE MET THE REQUIRED SPECIFICATION. THE CATHETER PASSED THE CONTINUITY TEST, THE EKG NOISE LEVEL TEST, THE PRESSURE DROP TEST, THE ABLATION SIMULATION TEST AND THE FLOW RATE TEST. THE CATHETER TIP WAS INVESTIGATED UNDER THE MICROSCOPE NO NONCONFORMITIES WERE OBSERVED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. THE ROOT CAUSE CLASSIFICATION IS ANTICIPATED PROCEDURAL COMPLICATIONS AS PERICARDIAL EFFUSION IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE IFU.

    Description of Event or Problem · 1

    SAME EVENT AS MFR REPORT 2030404-2012-00107. IT WAS REPORTED DURING A PVC ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. THE PHYSICIAN WAS CONDUCTING A PVC ABLATION FOR TWO DIFFERENT MORPHOLOGIES OF PVC'S WHILE UTILIZING ENSITE VELOCITY. A 7FR LIVEWIRE DUO DECA CATHETER WAS PLACED ALONG THE LATERAL WALL OF THE RIGHT ATRIUM AND INTO THE CORONARY SINUS. A 6FR IBI INQUIRY QUAD CATHETER WAS USED TO MARK THE HIS POSITION, AND PLACED IN THE RIGHT VENTRICLE. ALTHOUGH THE PVC'S WERE THOUGHT TO BE ORIGINATING IN THE LEFT VENTRICLE, THE PHYSICIAN WANTED TO MAP IN THE RIGHT VENTRICULAR OUTFLOW TRACT WITH THE IBI QUAD CATHETER TO CONFIRM THE ORIGIN PRIOR TO THE LEFT VENTRICLE. AFTER CONFIRMING LEFT SIDED ORIGINATION OF THE PVC'S, THE PHYSICIAN PROCEEDED IN PLACING A THERAPY COOL PATH ABLATION CATHETER INTO THE LEFT VENTRICLE VIA A RETROGRADE AORTIC APPROACH. A SUCCESSFUL 3D MAPPING OF ONE PVC MORPHOLOGY WAS ACHIEVED. THE LOCATION OF THE PVC PROVED TO BE DIFFICULT TO REACH VIA THE RETROGRADE AORTIC APPROACH, AND IT WAS THEN DECIDED TO ATTEMPT A TRANSSEPTAL APPROACH. A BRK NEEDLE, AN 8.5FR FAST-CATH SRO SHEATH, A 10FR FAST-CATH AND A 9FR VIEW FLEX PLUS ICE WERE USED TO SUCCESSFULLY GAIN TRANSSEPTAL ACCESS TO THE LEFT ATRIUM. RF ABLATION WITH THE THERAPY COOL PATH COMMENCED, HOWEVER THE PHYSICIAN DECIDED TO SWITCH TO A SAFIRE BLU CATHETER FOR BI-DIRECTIONAL STEERING FUNCTIONALITY. SUCCESSFUL ABLATION OF ONE PVC MORPHOLOGY WAS ACHIEVED. THE USER THEN STARTED TO MAP THE SECOND PVC MORPHOLOGY WHEN A SHORT TIME LATER, THE PT'S BLOOD PRESSURE DROPPED FROM THE LOW 100'S TO 60-80 MM HG SYSTOLIC. THE PT'S ACT WAS > 400 AND PROTIMINE WAS ADMINISTERED. ICE CONFIRMED A PERICARDIAL EFFUSION. ALL CATHETERS WERE REMOVED AND A PERICARDIOCENTESIS WAS PERFORMED. ROUGHLY 600CC'S OF BLOOD WAS REMOVED. THE AVERAGE PARAMETERS FOR IRRIGATED RF ABLATION WAS 30 WATTS, 40 TEMPERATURE. A CONVERSATION WITH THE PHYSICIAN AFTERWARDS REVEALED THAT, ALTHOUGH UNCERTAIN, HE THOUGHT HE MAY HAVE PERFORATED THE ANTERIOR WALL OF THE LEFT VENTRICLE AS HE HAD DIFFICULTY ON SEVERAL ATTEMPTS IN TRYING TO NAVIGATE BOTH THE THERAPY COOL PATH AND THE SAFIRE BLU THROUGH THE MITRAL VALVE INTO THE LEFT VENTRICLE. THE PT LEFT THE LAB IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFIRE BLU, 1304-CPS-7-25-MC-BD CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL, IRVINE A402871 3561824

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention LOT# K30430| REF#(B)(4), LOT# 1283916| LOT# 3574995| LOT# 3585181| 10FR FAST-CATH INTRODUCER REF# (B)(4),| 9FR VIEW FLEX PLUS ICE CATHETER REF# (B)(4),| THERAPY COOL PATH CATHETER REF# (B)(4),| LOT# K28286| 8.5FR FAST-CATH SRO SHEATH REF# (B)(4),| LOT# 3489105| 6FR IBI INQUIRY QUAD CATHETER REF# (B)(4),| 7FR RESTERILIZED LIVEWIRE DUO DECA CATHETER| BRK NEEDLE REF# (B)(4), LOT# 3112279| ENSITE VELOCITY: SERIAL AND MODEL NUMBER UNK