BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 5880603 · Received August 16, 2016

    Report

    Report Number
    3002648230-2016-00332
    Event Type
    Injury
    Date Received
    August 16, 2016
    Date of Event
    May 1, 2016
    Report Date
    July 19, 2016
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010/S015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 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 REFERENCED IN THE ARTICLE. THE BASELINE CHARACTERISTICS OF THE PATIENTS REFERENCED IN THE ARTICLE IS GENDER/AGE IS FEMALE/(B)(6) 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. REFERENCED ARTICLE: IMPACT OF THE ORDER OF THE TARGETED PULMONARY VEIN ON VAGAL RESPONSE DURING SECOND-GENERATION CRYOBALLOON ABLATION. HEART RHYTHM. 2016;13(5):1010-1017.

    Description of Event or Problem · 1

    THE LITERATURE PUBLICATION REPORTED THE FOLLOWING PATIENT COMPLICATIONS WHILE USING A 28 MM CRYOABLATION BALLOON: ONE (1) PATIENT HAD A AV BLOCK AND A PHRENIC NERVE INJURY (PHI). IT WAS UNKNOWN AT THIS TIME IF THE INJURY RECOVERED. THE STATUS/LOCATION OF THE CRYOABLATION BALLOON 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
    531565 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF284 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other