BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOL PATH¿ IRRIGATED ABLATION CATHETER

    MDR report key: 8596977 · Received May 9, 2019

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    Report

    Report Number
    2030404-2019-00033
    Event Type
    Injury
    Date Received
    May 9, 2019
    Report Date
    May 9, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT 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

    THE FOLLOWING WAS PUBLISHED IN THE JOURNAL OF ATRIAL FIBRILLATION IN AN ARTICLE TITLED ¿EFFECT OF NON-FLUOROSCOPIC CATHETER TRACKING ON RADIATION EXPOSURE DURING PULMONARY VEIN ISOLATION; COMPARISON OF FOUR ABLATION SYSTEMS¿ BY NARUSE Y, KECE F, DE RIVA M, ET AL., OCTOBER-NOVEMBER 2018. ¿ALTHOUGH 3-DIMENSIONAL ELECTRO-ANATOMICAL MAPPING SYSTEMS (EAMS) ARE ROUTINELY USED TO FACILITATE CATHETER NAVIGATION, CONVENTIONAL FLUOROSCOPY IS STILL NEEDED FOR INTRACARDIAC CATHETER MANIPULATION THROUGHOUT THE PROCEDURE. THEREFORE, TO MINIMIZE RADIATION EXPOSURE FOR BOTH PATIENTS AND PHYSICIANS, ALTERNATIVE CATHETER TRACKING SYSTEMS ARE NEEDED. SEVENTY-THREE CONSECUTIVE PATIENTS WHO WERE UNDERGOING PULMONARY VEIN ISOLATION PROCEDURE BY THE SAME OPERATIVE WERE ENROLLED IN THE STUDY. RADIATION TIME, RADIATION EFFECTIVE DOSE, PROCEDURE TIME, ATRIAL FIBRILLATION RECURRENCE AFTER ABLATION, AND PROCEDURE-RELATED COMPLICATIONS WERE COMPARED AMONG 4 DIFFERENT ABLATION SYSTEMS. IT WAS DETERMINED THAT THE MEDIGUIDE SYSTEM REDUCED RADIATION EXPOSURE WHEN COMPARED TO OTHER ABLATION SYSTEMS WITHOUT INCREASING ATRIAL FIBRILLATION RECURRENCE OF PROCEDURE-RELATED COMPLICATIONS. HOWEVER, DURING THE STUDY TWO CARDIAC PERFORATIONS OCCURRED THAT REQUIRED PERCUTANEOUS DRAINAGE.¿ (HTTPS://DOI.ORG/10.1093/EHJCI/EUX161.025).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390839 COOL PATH¿ IRRIGATED ABLATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention