BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER

    MDR report key: 7088438 · Received December 6, 2017

    Report

    Report Number
    3002648230-2017-00668
    Event Type
    Injury
    Date Received
    December 6, 2017
    Date of Event
    November 14, 2016
    Report Date
    August 1, 2019
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010/S015
    Adverse Event
    Yes
    Product Problem
    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

    CONTINUATION: FREEZOR MAX CARDIAC CRYOABLATION CATHETER; CRYOCONSOLE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE AND SUBSEQUENT FOLLOW UP INFORMATION OBTAINED. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. REFERENCED ARTICLE: ¿CORONARY ARTERY SPASM DURING CRYOBALLOON ABLATION IN A PATIENT WITH ATRIAL FIBRILLATION.¿ INTERN MED ADVANCE PUBLICATION DOI: 10.2169/INTERNALMEDICINE.9305-17.

    Description of Event or Problem · 1

    THE LITERATURE PUBLICATION REPORTS THE FOLLOWING PATIENT COMPLICATIONS WHILE USING A CRYOABLATION BALLOON: THE PATIENT EXPERIENCED ST ELEVATION, ALONG WITH HEART RATE DECREASE AND CHEST PAIN. FIVE MINUTES LATER, THE ST ELEVATION DEPRESSED. IV MEDICATION OF INTRA-CORONARY INJECTION OF NITROGLYCERIN WAS ADMINISTERED, AND THE CASE WAS CONTINUED. THE PATIENT¿S BLOOD PRESSURE FELL. CORONARY ARTERY SPASM AND STENOSIS WAS OBSERVED DURING THE CRYOABLATION PROCEDURE. ADDITIONAL INFORMATION OBTAINED FROM THE PHYSICIAN INDICATED THAT THERE WAS POSSIBLE AIR INGRESS; HOWEVER, THE PHYSICIAN ALSO STATED THAT THERE WAS NO AIR EMBOLUS SHOWN ON THE CORONARY ANGIOGRAPHY (CAG). THE PATIENT WAS DISCHARGED FOUR DAYS AFTER THE ABLATION PROCEDURE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866699 ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF284 50096

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L| R