BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER

    MDR report key: 19006105 · Received March 29, 2024

    Report

    Report Number
    3002648230-2024-00116
    Event Type
    Injury
    Date Received
    March 29, 2024
    Date of Event
    November 10, 2023
    Report Date
    March 29, 2024
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. THIS EVENT OCCURRED OUTSIDE THE US. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. 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. 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: ENLARGED RIGHT ATRIUM PREDICTS PACEMAKER IMPLANTATION AFTER ATRIAL FIBRILLATION ABLATION IN PATIENTS WITH TACHYCARDIA-BRADYCARDIA SYNDROME. IJC HEART & VASCULATURE. 2023. 49; 101297. DOI: 10.1016/J.IJCHA.2023.101297. 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 PACEMAKER IMPLANTATION AFTER ATRIAL FIBRILLATION (AF) ABLATION IN PATIENTS WITH TACHYCARDIA-BRADYCARDIA SYNDROME (TBS). THE AUTHORS DESCRIBED TWO PATIENTS WHO EXPERIENCED ABLATION PROCEDURE COMPLICATIONS; ONE PATIENT HAD A STROKE, AND ANOTHER HAD PERICARDITIS WITH A SMALL PERICARDIAL EFFUSION, WHICH WAS MANAGED WITHOUT PERICARDIOCENTESIS. SOME PATIENTS REQUIRED THE IMPLANT OF A PACEMAKER POST ABLATION DUE TO THE DEVELOPMENT OF SINUS BRADYCARDIA, RECURRENCE OF TBS DUE TO POST ABLATION ATRIAL TACHYCARDIA (AT), COMPLETE ATRIOVENTRICULAR (AV) BLOCK, AND ARRHYTHMIA RELATED SYMPTOMS WHICH INCLUDED SYNCOPE AND DIZZINESS. IN THE FOLLOW UP PERIOD THERE WERE PATIENTS HOSPITALIZED FOR CARDIOVASCULAR RELATED REASONS AND ONE PATIENT WITH CORONARY ARTERY DISEASE. 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
    2586833 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 NA Unknown Hospitalization| R