BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER

    MDR report key: 14118682 · Received April 15, 2022

    Report

    Report Number
    3002648230-2022-00167
    Event Type
    Injury
    Date Received
    April 15, 2022
    Date of Event
    August 25, 2021
    Report Date
    April 15, 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. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE BASELINE GENDER/AGE CHARACTERISTICS IS MALE/68 YEARS OLD. OF NOTE, MULTIPLE PATIENTS/MULTIPLE MANUFACTURERS/MULTIPLE METHODS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL/LOT NUMBERS/MANUFACTURER/METHOD. 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: "CONTRAST-ENHANCED COMPUTED TOMOGRAPHY FOR OPTIMIZING THE OUTCOMES OF PULMONARY VEIN ISOLATION WITH CRYOABLATION -THE ROLE OF ISOLATION OF PVS INCLUDING CARINA-" JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY. 2021. DOI.ORG/10.1007/S10840-021-01052-5 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 CRYO ABLATION TO TREAT ATRIAL FIBRILLATION (AF). THE ARTICLE REPORTED THAT ONE PATIENT EXPERIENCED A HEMATOMA AT THE ACCESS SITE AND ONE PATIENT EXPERIENCED A PNEUMOTHORAX. THE STATUS OF THE CATHETERS IS UNKNOWN. FOLLOW UP IS BEING CONDUCTED FOR ADDITIONAL INFORMATION ON THE CATHETERS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173667 ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF284

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Other