BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT BALLOON

    MDR report key: 10599596 · Received September 29, 2020

    Report

    Report Number
    3002648230-2020-00514
    Event Type
    Injury
    Date Received
    September 29, 2020
    Date of Event
    June 6, 2020
    Report Date
    September 29, 2020
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER 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 APPROXIMATELY 66 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: "PULMONARY VEIN ISOLATION WITH THE CRYOBALLOON IN OBESE ATRIAL FIBRILLATION PATIENTS ¿ DOES WEIGHT HAVE AN IMPACT ON PROCEDURAL PARAMETERS AND CLINICAL OUTCOME?" INTERNATIONAL JOURNAL OF CARDIOLOGY 316 (2020) 137¿142. DOI.ORG/10.1016/J.IJCARD.2020.06.001. 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 SYSTEM. THERE WERE PATIENTS WHO EXPERIENCED ¿PERMANENT¿ PHRENIC NERVE PALSY (PNP), STROKE/ TRANSIENT ISCHEMIC ATTACK (TIA), BLEEDING, AND AN EMBOLISM. ALL WITH UNKNOWN TREATMENT/RESOLUTION. OF NOTE, MULTIPLE PATIENTS 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 SYSTEM 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
    1063047 ARCTIC FRONT BALLOON PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP CRYO-UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R ACHIEVE MAPPING CATHETER