BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACHIEVE MAPPING CATHETER

    MDR report key: 6016845 · Received October 11, 2016

    Report

    Report Number
    3002648230-2016-00433
    Event Type
    Injury
    Date Received
    October 11, 2016
    Date of Event
    January 1, 2016
    Report Date
    September 13, 2016
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRF
    PMA / PMN Number
    K102588
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER. MEDTRONIC CRYOCATH WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE LITERATURE PUBLICATION OR TO MATCH THE EVENT WITH PREVIOUSLY REPORTED EVENTS. THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE BASELINE GENDER/AGE OF THE PATIENTS REFERENCED IN THE ARTICLE IS MALE/57 YEARS OF AGE. 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: ONE-YEAR FOLLOW-UP AFTER SECOND-GENERATION CRYOBALLOON ABLATION FOR ATRIAL FIBRILLATION IN A LARGE COHORT OF PATIENTS: A SINGLE-CENTRE EXPERIENCE. EUROPACE.2016;18(7):987-993.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE LITERATURE PUBLICATION REPORTED THAT THERE WAS THE FOLLOWING COMPLICATION WHILE USING A MAPPING SHEATH: THERE WAS A PATIENT WHO EXPERIENCED CARDIAC TAMPONADE. THE LOCATION/STATUS OF THE SHEATH IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669747 ACHIEVE MAPPING CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF MEDTRONIC CRYOCATH LP 990063-020

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening FLEXCATH STEERABLE SHEATH