BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTIPLE-SEE ATTACHED

    MDR report key: 1352272 · Received March 24, 2009

    Report

    Report Number
    2030404-2009-00005
    Event Type
    Injury
    Date Received
    March 24, 2009
    Date of Event
    March 18, 2009
    Report Date
    March 18, 2009
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NONE OF THE DEVICES WERE RETURNED FOR ANALYSIS. HOWEVER, THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO RELATED ISSUES FOUND IN MANUFACTURING. THE CAUSE FOR THE REPORTED PERICARDIAL EFFUSION REMAINS UNKNOWN. IT SHOULD BE NOTED THAT THE PHYSICIAN DOES NOT ALLEGE THE EFFUSION WAS CAUSED BY ANY SJM PRODUCTS. IN ADDITION, THE INSTRUCTIONS FOR USE (IFU) STATES THAT VASCULAR PERFORATION IS AN INHERENT RISK OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. MULTIPLE DEVICES WERE USED DURING THE PROCEDURE AND ALTHOUGH THE EFFUSION WAS PHYSICIAN IS UNSURE WHEN THE EFFUSION STARTED OR WHICH PRODUCT CAUSED THE EFFUSION BUT DID NOT BELIEVE ANY OF THE DEVICES MALFUNCTIONED. THE FOLLOWING ST. JUDE MEDICAL DEVICES WERE USED DURING THE PROCEDURE: RESPONSE CSL REF# (B)(4), LOT #2746295, BRK-1 98 CM NEEDLE REF # (B)(4), LOT #2747278, OPTIMA PLUS DIAGNOSTIC CATHETER REF # (B)(4), LOT #K09251, COOL PATH LARGE CURL ABLATION CATHETER REF # (B)(4), LOT #K09849. SEQUENCE OF EVENTS, AS REPORTED: "DURING ROUTINE AF ABLATION, A TRANSSEPTAL WAS PERFORMED USING A BRK-1 98 CM NEEDLE AND AN AGILIS SHEATH. THERE WERE NO COMPLICATIONS DURING THE TRANSEPTAL. AN OPTIMA PLUS CATHETER WAS INTRODUCED THROUGH THE AGILIS INTRODUCER SHEATH INTO THE LEFT ATRIUM AND THE CHAMBER WAS MAPPED FOR PULMONARY VEIN CONDUCTION AND ATRIAL FIBRILLATION. THE OPTIMA PLUS CATHETER WAS EXCHANGED FOR A COOL PATH ABLATION CATHETER AND ABLATION WAS PERFORMED AROUND THE ANTERUM OF THE PULMONARY VEINS FOR ABOUT 1-2 HOURS. AFTER ABLATION, THE COOL PATH CATHETER WAS EXCHANGED FOR THE OPTIMA PLUS CATHETER TO REASSESS PULMONARY VEIN CONDUCTION. IT WAS DETERMINED THAT THE LEFT SIDED PULMONARY COMMON ANTERUM WAS ISOLATED BUT THERE WAS STILL RESIDUAL CONDUCTION IN BOTH OF THE RIGHT SIDED PULMONARY VEINS. THE OPTIMA PLUS CATHETER WAS EXCHANGED FOR A SAFIRE TX 8-MM ABLATION CATHETER (MEDIUM CURL) AND ABLATION WAS PERFORMED ON THE ANTERUM OF THE RIGHT SIDED PULMONARY VEINS. AFTER ISOLATING THE RIGHT SUPERIOR PULMONARY VEIN AND WHILE ABLATING AROUND THE RIGHT INTERIOR PULMONARY VEIN, A PERICARDIAL EFFUSION WAS OBSERVED ON INTRACARDIAC ECHO AND THE LEFT SIDED ABLATION WAS TERMINATED. THE CATHETER AND SHEATH WERE IMMEDIATELY REMOVED FROM THE LEFT ATRIUM AND THE HEPARIN WAS DISCONTINUED AND REVERSED WITH PROTAMINE. THE PT'S PRESSURES REMAINED STABLE AND A PERICARDIAL CENTESIS KIT WAS OPENED. PHYSICIAN IS UNSURE OF WHEN THE EFFUSION STARTED OR WHICH PRODUCT CAUSED THE EFFUSION. THERE IS NO CONCERN ABOUT WHETHER THE PROBLEM IS DUE TO CATHETER OR SHEATH MALFUNCTION." IT SHOULD BE NOTED THAT THE PHYSICIAN DOES NOT ALLEGE THE EFFUSION WAS CAUSED BY ANY SJM PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIPLE-SEE ATTACHED OAD ST. JUDE MEDICAL MULTIPLE SEE ATTACHED

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention TOPOROL