BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFLEXION¿ SPIRAL EP CATHETER

    MDR report key: 7836171 · Received August 30, 2018

    Report

    Report Number
    2182269-2018-00113
    Event Type
    Injury
    Date Received
    August 30, 2018
    Report Date
    August 30, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT OF A CARDIAC PERFORATION WAS REPORTED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED CARDIAC PERFORATION COULD NOT BE CONCLUSIVELY DETERMINED. PER THE IFU, CARDIAC PERFORATION IS A KNOWN RISK DURING THE USE OF THIS DEVICE.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REPORT NUMBER: 2182269-2018-00111, 2182269-2018-00112, 3008452825-2018-00295, 3005334138-2018-00288, (1) 9680001-2018-00128. THE FOLLOWING WAS PUBLISHED IN THE JOURNAL OF ATRIAL FIBRILLATION IN AN ARTICLE TITLED "TWO YEAR, SINGLE CENTER CLINICAL OUTCOME AFTER CATHETER ABLATION FOR PAROXYSMAL ATRIAL FIBRILLATION GUIDED BY LESION INDEX", VOLUME 11(1). ¿FIFTY CONSECUTIVE PATIENTS WITH PAF UNDERWENT PULMONARY VEIN (PV) ISOLATION USING A CATHETER DRAGGING TECHNIQUE AND TARGETING DIFFERENT LSI VALUES IN DIFFERENT ANATOMICAL AREAS. A FORCE-SENSING ABLATION CATHETER WAS USED TO CONTINUOUSLY MEASURE CONTACT FORCE (CF) AND GUIDE RADIOFREQUENCY ABLATION (RF) LESION FORMATION. ABLATION LESIONS WERE DELIVERED TO ACHIEVE AN LSI VALUE OF 5.0 IN POSTERIOR LOCATIONS, 5.5 IN ANTERIOR LOCATIONS AND 6.0 IN THE REGION BETWEEN THE LEFT ATRIAL APPENDAGE AND LEFT SUPERIOR PULMONARY VEIN RIDGE. FORCE-TIME INTEGRAL (FTI) WAS NOT USED TO EVALUATE LESION FORMATION.¿ "A 4.0% (2/50) ACUTE COMPLICATION RATE WAS OBSERVED WITH BOTH AS PERICARDIAL EFFUSIONS WITH TAMPONADE PHYSIOLOGY. BOTH PATIENTS REQUIRED PERCUTANEOUS DRAINAGE WITH RESOLUTION OF THE EFFUSION. THERE WERE NO OTHER COMPLICATIONS NOTED." (DOI:10.4022/JAFIB.1760). .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672633 REFLEXION¿ SPIRAL EP CATHETER ELECTROPHYSIOLOGY DRF ST. JUDE MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention AGILIS¿ INTRODUCER, UNKNOWN| LIVEWIRE¿ ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER| SWARTZ¿ INTRODUCER, UNKNOWN| TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER| TRANSSEPTAL NEEDLE, BRK SERIES