BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER

    MDR report key: 20065329 · Received August 26, 2024

    Report

    Report Number
    3002648230-2024-00391
    Event Type
    Injury
    Date Received
    August 26, 2024
    Report Date
    August 26, 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. A REQUEST FOR ADDITIONAL INFORMATION WAS MADE. IF ADDITIONAL INFORMATION IS OBTAINED REGARDING THIS EVENT, IT WILL BE ADDED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: PROGNOSTIC IMPORTANCE OF B-TYPE NATRIURETIC PEPTIDE LEVEL IN PATIENTS UNDERGOING CATHETER ABLATION FOR ATRIAL FIBRILLATION. CIRCULATION JOURNAL. 2023; 87: 1730¿1739. DOI: 10.1253/CIRCJ.CJ-23-0263. 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 THE PROGNOSTIC IMPORTANCE OF B-TYPE NATRIURETIC PEPTIDE (BNP) CONCENTRATIONS FOR CLINICAL EVENTS AFTER CATHETER ABLATION FOR ATRIAL FIBRILLATION (AF). THE PRIMARY OUTCOME MEASURE WAS RECURRENT ATRIAL TACHYARRHYTHMIAS AFTER THE PROCEDURE. THE SECONDARY OUTCOME MEASURES WERE A COMPOSITE HEART FAILURE (HF) ENDPOINT, DEFINED AS A COMPOSITE OF HF HOSPITALIZATION OR CARDIAC DEATH. THE AUTHORS DESCRIBED PATIENT DEATHS; HOWEVER, THE CAUSES OF DEATH WERE UNKNOWN. THERE WERE PATIENTS WHO EXPERIENCED HEART FAILURE HOSPITALIZATIONS AND NEW ONSET RECURRENT ATRIAL TACHYARRHYTHMIAS. THERE IS NO ALLEGATION OR IDENTIFIABLE CONNECTION THAT THE ABLATION PROCEDURES WERE RELATED TO THE DEATHS OR HEART FAILURE; HOWEVER, THE CAUSE OF DEATH AND RELATEDNESS HAS BEEN REQUESTED. 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
    1293174 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