BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INQUIRY? ELECTROPHYSIOLOGY CATHETER

    MDR report key: 4081917 · Received September 11, 2014

    Report

    Report Number
    3008452825-2014-00036
    Event Type
    Injury
    Date Received
    September 11, 2014
    Date of Event
    August 13, 2014
    Report Date
    August 13, 2014
    Manufacturer
    ST. JUDE MEDICAL, COSTA RICA LTDA
    Product Code
    DRF
    PMA / PMN Number
    PK961924
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    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 PERFORATION IS A KNOWN INHERENT RISK OF ANY ELECTRODE PLACEMENT.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE 2030404-2014-00087, 3005188751-2014-00105, 3005188751-2014-00106, 3008452825-2014-00035, 3005188751-2014-00107 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
    561160 INQUIRY? ELECTROPHYSIOLOGY CATHETER ELECTRODE RECORDING CATHETER DRF ST. JUDE MEDICAL, COSTA RICA LTDA 81603 4479945

    Patients

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