BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER

    MDR report key: 23476360 · Received November 5, 2025

    Report

    Report Number
    3002648230-2025-01078
    Event Type
    Injury
    Date Received
    November 5, 2025
    Date of Event
    June 24, 2025
    Report Date
    November 5, 2025
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THIS EVENT OCCURRED OUTSIDE THE US. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE BASELINE GENDER/AGE CHARACTERISTICS IS FEMALE/65 YEARS OLD. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE MODEL FAMILY, AS THERE IS NO SPECIFIC MODEL LISTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE, EXPIRATION DATE, AND UDI 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: IATROGENIC LACERATION OF THE ATRIAL SEPTUM DURING CATHETER ABLATION FOR ATRIAL FIBRILLATION IN A PATIENT WITH MULTIPLE ATRIAL SEPTAL DEFECTS CARDIOVASCULAR INTERVENTION AND THERAPEUTICS (2025) 40:1033¿1035 DOI.ORG/10.1007/S12928-025-01163. 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 A 66-YEAR-OLD WOMAN WITH MULTIPLE ATRIAL SEPTAL DEFECTS (ASDS) AND PAROXYSMAL ATRIAL FIBRILLATION UNDERWENT A CRYOABLATION. FOLLOWING THE PROCEDURE, SHE EXPERIENCED MILD EXERTIONAL DYSPNEA DESPITE RESTORATION OF SINUS RHYTHM. FIVE MONTHS LATER, AT THE TIME OF ASD CLOSURE, HER RIGHT VENTRICULAR MIDCAVITY DIAMETER HAD INCREASED FROM 38 TO 45 MILLIMETERS (MM). THE POSTERIOR RIM OF ASD2 WAS MECHANICALLY TORN BY MANIPULATION OF THE SHEATH INTRODUCER (UNKNOWN MANUFACTURER) AND BALLOON CATHETER ACROSS THE DEFECT. THE CLOSURE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE STATUS OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2550597 ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF284 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention