BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 5760156 · Received June 29, 2016

    Report

    Report Number
    3002648230-2016-00260
    Event Type
    Injury
    Date Received
    June 29, 2016
    Date of Event
    June 15, 2016
    Report Date
    June 15, 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

    PRODUCT EVENT SUMMARY: THE DATA FILES FOR THE DATE OF THE REPORTED EVENT WERE RETURNED AND ANALYZED. THE DATA FILES DID NOT SHOW ANY SYSTEM NOTICES OR ISSUES. THE REPORTED BALLOON CATHETER, 2AF284 WITH LOT NUMBER 65450, WAS NOT RETURNED FOR ANALYSIS; NO PRODUCT MALFUNCTION WAS REPORTED. A KNOWN CLINICAL ISSUE WAS ENCOUNTERED DURING THE PROCEDURE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE PATIENT EXPERIENCED A PHRENIC NERVE INJURY (PNI). IT WAS NOTED THAT NO INTERVENTION WAS PERFORMED AND THE PHRENIC NERVE INJURY (PNI) HAD NOT RECOVERED BEFORE THE PATIENT WAS DISCHARGED. THE PROCEDURE WAS COMPLETED RADIOFREQUENCY (RF) ABLATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412961 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF284 65450

    Patients

    Seq Age Sex Outcome Treatment
    1 Other