BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 7528703 · Received May 21, 2018

    Report

    Report Number
    3002648230-2018-00325
    Event Type
    Injury
    Date Received
    May 21, 2018
    Date of Event
    April 24, 2018
    Report Date
    June 28, 2018
    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

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

    Additional Manufacturer Narrative · 1

    EVENT SUMMARY: PATIENT DATA FILES SHOWED AT LEAST EIGHT INJECTIONS WERE PERFORMED WITH CATHETER 2AF284/90108-65 ON THE DATE OF THE EVENT WITHOUT TRIGGERING OF ANY SYSTEM NOTICE. IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE PATIENT COMPLAINED OF CHEST PAIN WHILE THE BALLOON OCCLUDED THE RIGHT SUPERIOR PULMONARY VEIN (RSPV). BLOOD PRESSURE CHANGES WERE OBSERVED, AND ATROPINE WAS ADMINISTERED. THE BALLOON CATHETER 2AF284/ 90108-65 WAS NOT RETURNED FOR INVESTIGATION. IN CONCLUSION, THIS IS A CASE RELATED TO CLINICAL ADVERSE EVENTS (CHEST PAIN AND BLOOD PRESSURE CHANGE). THE BALLOON WAS NOT RETURNED FOR INVESTIGATION. 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 COMPLAINED OF CHEST PAIN WHILE THE BALLOON OCCLUDED THE RIGHT SUPERIOR PULMONARY VEIN (RSPV). BLOOD PRESSURE CHANGES WERE OBSERVED AND ATROPINE WAS ADMINISTERED. THE CHEST PAIN RESOLVED. THE CASE WAS ABLE TO BE COMPLETED WITH CRYO. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373443 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF284 90108

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention