BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT CARDIAC CRYOABLATION CATHETER

    MDR report key: 6606046 · Received June 1, 2017

    Report

    Report Number
    3002648230-2017-00254
    Event Type
    Injury
    Date Received
    June 1, 2017
    Date of Event
    January 1, 2017
    Report Date
    May 8, 2017
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC CRYOCATH WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC PATIENT OR DEVICE INFORMATION FROM THE LITERATURE PUBLICATION OR TO MATCH THE EVENT WITH PREVIOUSLY REPORTED EVENTS. THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT LOT NUMBERS. THE BASELINE GENDER/AGE CHARACTERISTIC IS MALE/58 YEARS OLD FOR THE PATIENTS REFERENCED IN THE ARTICLE. 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: ¿PRESSURE-GUIDED CRYOABLATION OF PULMONARY VEINS IN ATRIAL FIBRILLATION: A FAST AND EFFECTIVE STRATEGY.¿ INDIAN HEART JOURNAL 69 (2017) 223¿225. HTTP://DX.DOI.ORG/10.1016/J.IHJ.2016.11.330. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 REPORTS THE FOLLOWING PATIENT COMPLICATION WHILE USING A CRYOABLATION BALLOON: MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT LOT NUMBERS. THERE WERE FOUR (4) PATIENTS WHO EXPERIENCED PHRENIC NERVE PALSY (PNP); ALL OF WHICH WERE WITH UNKNOWN TREATMENT/OUTCOME. THE STATUS/LOCATION OF THE CRYOBALLOON 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
    387732 ARCTIC FRONT CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF282

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other