BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 4210555 · Received October 29, 2014

    Report

    Report Number
    3002648230-2014-00182
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 1, 2014
    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

    THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION; IT WAS DISCARDED AFTER THE PROCEDURE. BIN FILES WERE REVIEWED AND DID NOT SHOW ANY SYSTEM NOTICE MESSAGES FOR THE DATE OF EVENT. BIN FILES SHOWED AT LEAST 15 INJECTIONS WERE PERFORMED WITH THE CATHETER. 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

    MEDTRONIC RECEIVED INFORMATION OF A PHRENIC NERVE PARALYSIS THAT OCCURRED AT THE CRYOABLATION OF THE RIGHT SUPERIOR PULMONARY VEIN ( RSPV). CRYOABLATION OF RSPV WAS PERFORMED AFTER THE CRYOABLATION OF THE LEFT PULMONARY VEINS AND THE RIGHT INFERIOR PULMONARY VEIN. EIGHTY SECONDS AFTER THE START OF RSPV CRYOABLATION, THE DIAPHRAGM RESPONSE ON PALPATION WAS DECREASED AND THE ABLATION WAS STOPPED. THE CRYOABLATION PROCEDURE WAS COMPLETED AND THE PATIENT IS BEING MONITORED. A CHEST X-RAY PERFORMED ON (B)(6) 2014 CONFIRMED RECOVERY OF THE PHRENIC NERVE PARALYSIS.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION OF A PHRENIC NERVE PARALYSIS THAT OCCURRED AT THE CRYOABLATION OF THE RIGHT SUPERIOR PULMONARY VEIN (RSPV). CRYOABLATION OF RSPV WAS PERFORMED AFTER THE CRYOABLATION OF THE LEFT PULMONARY VEINS AND THE RIGHT INFERIORPULMONARY VEIN. 80 SECONDS AFTER THE START OF RSPV CRYOABLATION, THE DIAPHRAGM RESPONSE ON PALPATION WAS DECREASED AND THE ABLATION WAS STOPPED. THE CRYOABLATION PROCEDURE WAS COMPLETED AND THE PATIENT IS BEING MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691374 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF284 11940

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Other