BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOL FLEX CATHETER

    MDR report key: 10984392 · Received December 10, 2020

    Report

    Report Number
    2030404-2020-00106
    Event Type
    Injury
    Date Received
    December 10, 2020
    Report Date
    December 10, 2020
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    OAD
    PMA / PMN Number
    P110016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF CARDIAC TAMPONADE COULD NOT BE CONFIRMED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS NOT POSSIBLE AS A LOT NUMBER WAS NOT AVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED HEMATOMA COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS PUBLISHED IN THE KOREAN CIRCULATION JOURNAL TITLED, "LONG-TERM EFFICACY OF PROPHYLACTIC CAVOTRICUSPID ISTHMUS ABLATION DURING ATRIAL FIBRILLATION ABLATION IN PATIENTS WITHOUT TYPICAL ATRIAL FLUTTER: A PROSPECTIVE, MULTICENTRE, RANDOMIZED TRIAL" BY SUNG-HWAN KIM, ET AL.: SUCCESSFUL PVI WAS ACHIEVED IN ALL PATIENTS. IN THE PVI PLUS CTI BLOCK GROUP, CTI BLOCK WITH A BIDIRECTIONAL BLOCK WAS MADE IN ALL PATIENTS. THERE WAS NO SIGNIFICANT DIFFERENCE IN PROCEDURE TIME IN BOTH GROUPS BECAUSE MOST CTI BLOCK WAS PERFORMED DURING THE WAITING TIME AFTER COMPLETION OF PVI (176.8±72.6 MINUTES IN THE PVI GROUP VS. 174.2±76.5 MINUTES IN THE PVI+CTI BLOCK GROUP, P=0.75). PROCEDURAL COMPLICATIONS OCCURRED; 1 CARDIAC TAMPONADE (THE PVI GROUP), 1 PSEUDOANEURYSM IN THE FEMORAL PUNCTURE SITE (THE PVI GROUP), 2 HEMATOMAS IN THE FEMORAL PUNCTURE SITE (1 IN THE PVI GROUP, 1 IN THE PVI+CTI BLOCK GROUP). THE CARDIAC TAMPONADE WAS NOT ATTRIBUTED TO THE COOL FLEX CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1451112 COOL FLEX CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD ST. JUDE MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other