BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 3161600 · Received June 11, 2013

    Report

    Report Number
    3002648230-2013-00093
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    April 2, 2013
    Report Date
    May 13, 2013
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010/S015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. BIN FILES WERE REVIEWED AND DO NOT SHOW SYSTEM NOTICES OR ISSUES FOR THE DATE OF EVENT. BIN FILES SHOW AT LEAST 22 INJECTIONS WERE PERFORMED WITH THE CATHETER. THERE WAS NO INDICATION OF PRODUCT MALFUNCTION. THIS REPORT WILL BE RECORDED AND TRENDED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE PATIENT DEVELOPED A COUGH FOLLOWING CRYOABLATION PROCEDURE. MEDICATIONS PRESCRIBED BY THE PATIENT'S GENERAL PRACTITIONER DID NOT HELP. PATIENT WAS SEEN BY STUDY PRINCIPAL INVESTIGATOR AND WAS DIAGNOSED WITH GASTROESOPHAGEAL REFLUX DISEASE (GERD), POSSIBLY RELATED TO ESOPHAGEAL IRRITATION DURING THE CRYOABLATION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261824 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 00055 YR Other