BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACHIEVE ADVANCE MAPPING CATHETER

    MDR report key: 19667699 · Received July 3, 2024

    Report

    Report Number
    2182208-2024-02684
    Event Type
    Injury
    Date Received
    July 3, 2024
    Date of Event
    September 8, 2023
    Report Date
    July 3, 2024
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DRF
    PMA / PMN Number
    K162892
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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. THE BASELINE GENDER/AGE CHARACTERISTICS IS MALE/58 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. 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: PRE-PROCEDURAL RIGHT ATRIAL DIAMETER MAY PREDICT THE DEVELOPMENT OF TYPICAL ATRIAL FLUTTER IN PATIENTS UNDERGOING CATHETER ABLATION FOR ATRIAL FIBRILLATION. THE ANATOLIAN JOURNAL OF CARDIOLOGY. 2023; 27(12): 697-705. DOI:10.14744/ANATOLJCARDIOL.2023.3324. 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 VARIABLES ASSOCIATED WITH THE DEVELOPMENT OF TYPICAL ATRIAL FLUTTER AFTER ABLATION. THE AUTHORS DE SCRIBED PATIENTS WHO UNDERWENT CRYOBALLOON ABLATION AND EXPERIENCED PERICARDIAL EFFUSION, CARDIAC TAMPONADE, PHRENIC NERVE PALSY, TRANSIENT ISCHEMIC ATTACK (TIA), AND GROIN COMPLICATIONS WHICH INCLUDED ONE FEMORAL ARTERIOVENOUS FISTULA WHICH REQUIRED SURGICAL REPAIR. THERE WERE PATIENTS WHO DEVELOPED NEW ONSET ATRIAL FLUTTER AFTER ABLATION. THE STATUS OF THE CATHETERS AND SHEATHS IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785668 ACHIEVE ADVANCE MAPPING CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT DRF MEDTRONIC, INC. 2ACH20

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Life Threatening| R