BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 2830008 · Received November 13, 2012

    Report

    Report Number
    3002648230-2012-00106
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    October 14, 2012
    Report Date
    October 15, 2012
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010/S015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. THERE WAS NO INDICATION OF PRODUCT MALFUNCTION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A CRYOABLATION PROCEDURE WAS PERFORMED ON (B)(6) 2012 WITH GOOD PVI RESULTS AND NO ACUTE ISSUES. ON (B)(6) 2012, THE PATIENT WAS ADMITTED TO HOSPITAL WITH SEVERE ABDOMINAL DISCOMFORT AND GI UPSET (NAUSEA AND VOMITING). DETAILS OF THE CASE ON (B)(6) 2012 INCLUDED A VAGAL RESPONSE DURING THAWING AFTER CRYOABLATION OF THE LSPV. THE PHYSICIAN SUSPECTS VAGAL NERVE DAMAGE DURING THE FREEZE/THAW. AS PER PHYSICIAN, THE PATIENT SYMPTOMS ARE INDICATIVE OF GASTROPARESIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization