BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER

    MDR report key: 19032249 · Received April 3, 2024

    Report

    Report Number
    3002648230-2024-00131
    Event Type
    Injury
    Date Received
    April 3, 2024
    Date of Event
    January 1, 2023
    Report Date
    April 3, 2024
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. OF NOTE, MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE-TO-ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL/LOT NUMBERS. THE BASELINE GENDER/AGE CHARACTERISTICS IS MALE/67 YEARS OLD. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REFERENCED ARTICLE: RELATIONSHIP BETWEEN AMIODARONE RESPONSE PRIOR TO ABLATION AND 1-YEAR OUTCOMES OF CATHETER ABLATION FOR ATRIAL FIBRILLATION. JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY (JCE). 2023; 34:860¿868. DOI: 10.1111/JCE.15845. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING AMIODARONE RESPONSE PRIOR TO CRYOBALLOON ABLATION AND OUTCOMES. PATIENTS WERE PUT IN COHORTS BY AM IODARONE FAILURE VERSUS AMIODARONE SUCCESS. THE AUTHORS DESCRIBED PROCEDURAL COMPLICATIONS THAT OCCURRED IN BOTH GROUPS WHICH INCLUDED CARDIAC TAMPONADE, UNKNOWN VASCULAR COMPLICATIONS, ASPIRATION PNEUMONIA, AND PULMONARY EMBOLISM. THE STATUS OF THE CATHETERS IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1448115 ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF284

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Life Threatening