BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 10228369 · Received July 3, 2020

    Report

    Report Number
    3002648230-2020-00336
    Event Type
    Injury
    Date Received
    July 3, 2020
    Date of Event
    January 1, 2018
    Report Date
    July 2, 2020
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. 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 OVERALL BASELINE GENDER CHARACTERISTICS IS MALES; THE AGE OF THE PATIENTS WAS 60 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: ¿TEMPORAL TRENDS IN SAFETY AND COMPLICATION RATES OF CATHETER ABLATION FOR ATRIAL FIBRILLATION.¿ JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY. 2018; 29(6):854-860.DOI: 10.1111/JCE.13484. 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 AN ABLATION PROCEDURE USING A CRYOBALLOON ABLATION CATHETER: THERE WERE PATIENTS WHO EXPERIENCED ATRIOESOPHAGEAL FISTULAS, VASCULAR HEMATOMA, PSEUDOANEURYSM, BLEEDING, ATRIOVENTRICULAR BLOCK, ASPIRATION PNEUMONIA, PERFORATION/TAMPONADE, PHRENIC NERVE PARALYSIS, EMBOLIC STROKE, AND PULMONARY VEIN STENOSIS. TREATMENT INCLUDED DRAINAGE,AND/OR SURGICAL REPAIR. 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 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
    691779 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF284

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R