BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 5047856 · Received September 1, 2015

    Report

    Report Number
    3002648230-2015-00251
    Event Type
    Injury
    Date Received
    September 1, 2015
    Date of Event
    August 5, 2015
    Report Date
    August 6, 2015
    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

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DATA FILE ANALYSIS FOR DEVICE 2AF284 WITH LOT #39233-03 DID NOT DEMONSTRATE A SYSTEM NOTICE RELATED TO THE ADVERSE EVENT. A KNOWN CLINICAL ADVERSE EVENT OCCURRED DURING THE PROCEDURE. NO PRODUCT WAS RETURNED FOR ANALYSIS.

    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 AN ABLATION PROCEDURE, FOLLOWING ABLATION OF THE LEFT INFERIOR PULMONARY VEIN (LIPV), THE PATIENT'S BLOOD PRESSURE DROPPED. THE PROCEDURE WAS STOPPED AND IT WAS DISCOVERED THAT THE PATIENT HAD EXPERIENCED CARDIAC TAMPONADE. AT THIS POINT THE PROCEDURE WAS TERMINATED. THE PATIENT WAS STABLE THE FOLLOWING DAY, AND HOSPITALIZATION WAS EXTENDED AN ADDITIONAL DAY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578170 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF284 39233

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L