BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE PRO¿ CARDIAC CRYOABLATION CATHETER

    MDR report key: 13968436 · Received March 31, 2022

    Report

    Report Number
    3002648230-2022-00133
    Event Type
    Injury
    Date Received
    March 31, 2022
    Date of Event
    September 25, 2021
    Report Date
    March 31, 2022
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010/S015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. THIS EVENT OCCURRED OUTSIDE THE US. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. OF NOTE, MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE-TO-ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL/LOT NUMBERS. THE BASELINE GENDER/AGE CHARACTERISTICS IS MALE/70 YEARS OLD. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE MODEL FAMILY, AS THERE IS NO SPECIFIC MODEL LISTED. 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: COMPARISON OF CRYOBALLOON AND CONTACT FORCE-SENSING RADIOFREQUENCY ABLATION FOR PERSISTENT ATRIAL FIBRILLATION IN CLINICAL PRACTICE. CIRCULATION JOURNAL. 2022; 86: 290 ¿ 298. DOI: 10.1253/CIRCJ.CJ-21-0608. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING CRYOBALLOON ABLATION. THE ARTICLE REPORTS PATIENTS WHO EXPERIENCED PERIPROCEDURAL COMPLICATIONS SUCH AS CARDIAC TAMPONADE, PERICARDIAL EFFUSION, CORONARY ARTERY SPASMS, HEMATOMAS, PHRENIC NERVE PALSY, AND PERIPHERAL THROMBOSIS. IT IS UNKNOWN WHETHER ANY INTERVENTION WAS PERFORMED. THE STATUS/ DISPOSITION OF THE CATHETERS AND SHEATHS IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1345838 ARCTIC FRONT ADVANCE PRO¿ CARDIAC CRYOABLATION CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP AFAPRO28

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Life Threatening