BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFLEXION? SPIRAL VARIABLE RADIUS CATHETER 5 F LOOP BI-DIRECTIONAL

    MDR report key: 4081922 · Received September 11, 2014

    Report

    Report Number
    3005188751-2014-00105
    Event Type
    Injury
    Date Received
    September 11, 2014
    Date of Event
    August 13, 2014
    Report Date
    August 13, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC. (AF-MINNETONKA)
    Product Code
    DRF
    PMA / PMN Number
    PK072012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. OUR INVESTIGATION WAS LIMITED TO THE REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWED THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETE IN ACCORDANCE WITH SJM SPECIFICATIONS AND PROCEDURES. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED PERICARDIAL EFFUSION COULD NOT BE CONCLUSIVELY DETERMINED. PER THE IFU, VASCULAR AND/OR CARDIAC PERFORATION IS A KNOWN RISK DURING THE USE OF THIS DEVICE.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE 2030404-2014-00087, 3005188751-2014-00106, 3008452825-2014-00035, 3005188751-2014-00107, 3008452825-2014-00036 DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. AN INQUIRY STEERABLE EP CATHETER WAS PLACED AT THE BUNDLE OF HIS AND ANOTHER INQUIRY STEERABLE EP CATHETER WAS PLACED IN THE CORONARY SINUS. AN AGILIS NXT INTRODUCER AND A SWARTZ BRAIDED TRANSSEPTAL INTRODUCER WERE PLACED IN THE LEFT ATRIUM THROUGH THE PATENT FORAMEN OVALE. THE LEFT ATRIUM WAS MAPPED USING A REFLEXION SPIRAL EP CATHETER AND A CONTACT THERAPY COOL PATH DUO ABLATION CATHETER; THEN THE REFLEXION SPIRAL WAS ADVANCED INTO THE LEFT SUPERIOR PULMONARY VEIN (LSPV). ABLATION WAS INITIATED ON THE LSPV ANTRUM AND THE PATIENT COMPLAINED OF CHEST PAIN WHEN BREATHING. AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION, FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THE PROCEDURE WAS ABORTED AND THE PATIENT REMAINED STABLE. THERE WERE NO PERFORMANCE ISSUES WITH ANY SJM DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561208 REFLEXION? SPIRAL VARIABLE RADIUS CATHETER 5 F LOOP BI-DIRECTIONAL ELECTRODE RECORDING CATHETER DRF ST. JUDE MEDICAL, INC. (AF-MINNETONKA) D402865 4560173

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention CONTACT THERAPY COOL PATH DUO CATHETER| IBI-1500T11 CARDIAC ABLATION GENERATOR| SWARTZ BRAIDED TRANSSEPTAL INTRODUCER| AGILIS NXT INTRODUCER| INQUIRY DECAPOLAR EP CATHETER| INQUIRY QUADRIPOLAR EP CATHETER