BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER

    MDR report key: 10059166 · Received May 14, 2020

    Report

    Report Number
    3002648230-2020-00275
    Event Type
    Malfunction
    Date Received
    May 14, 2020
    Date of Event
    December 30, 2019
    Report Date
    May 15, 2020
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: FURTHER REVIEW PROMPTED A CHANGE IN THE REPORT TYPE. THE CHANGE IS REFLECTED IN THIS REPORT UNDER SECTION H1 - TYPE OF REPORTABLE EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE LITERATURE PUBLICATION OR TO MATCH THE EVENT WITH PREVIOUSLY REPORTED EVENTS. THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. OF NOTE, MULTIPLE PATIENTS/MULTIPLE METHODS/MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT LOT/SERIAL NUMBERS/METHODS/MANUFACTURERS. THE OVERALL BASELINE GENDER CHARACTERISTICS IS MALE; THE AGE OF THE PATIENTS WAS 61 YEARS OLD. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. A REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: ¿IMPACT OF TYPE-2 DIABETES MELLITUS ON THE OUTCOMES OF CATHETER ABLATION OF ATRIAL FIBRILLATION (EUROPEAN OBSERVATIONAL MULTICENTRE STUDY).¿ AM J CARDIOL. 2020 MAR 15;125(6):901-906. DOI: 10.1016/J.AMJCARD.2019.12.037. EPUB 2019 DEC 30. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE LITERATURE PUBLICATION REPORTED THE FOLLOWING PATIENT COMPLICATIONS DURING A PROCEDURE USING A CRYOBALLOON ABLATION CATHETER: THERE WERE PATIENTS WHO EXPERIENCED CARDIAC TAMPONADE, TRANSIENT ISCHEMIC ATTACK (TIA), STROKE, TRANSIENT PHRENIC NERVE PALSY (PNP), ¿MAJOR¿ VASCULAR COMPLICATIONS, ESOPHAGEAL FISTULAS, GASTROPARESIS, ESOPHAGEAL ULCER, BLEEDING, ARRHYTHMIA, ANAPHYLAXIS, TRANSIENT MYOCARDIAL STUNNING, PULMONARY VEIN STENOSIS, AIR EMBOLISM, AND ACUTE PULMONARY EDEMA. OF NOTE, MULTIPLE PATIENTS/MANUFACTURERS/METHODS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT LOT/SERIAL NUMBERS. THE STATUS/LOCATION OF THE CRYOBALLOON CATHETER IS UNKNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521119 ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF283

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L