BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE PRO CARDIAC CRYOABLATION CATHETER

    MDR report key: 10932170 · Received December 2, 2020

    Report

    Report Number
    3002648230-2020-00627
    Event Type
    Injury
    Date Received
    December 2, 2020
    Date of Event
    June 2, 2020
    Report Date
    December 1, 2020
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010/S015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. THE BASELINE AGE WAS 70-80 YEARS. 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: RESULTS OF A SURVEY CONCERNING ATRIAL FIBRILLATION ABLATION STRATEGIES IN POLAND KARDIOLOGIA POLSKA 2020; 78 (10): 974-981 DOI: 10.33963/KP.15407. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING CRYOABLATION STRATEGIES. THE ARTICLE IS COMPRISED OF RESULTS FROM A DISTRIBUTED SURVEY. THE ARTICLE SHOWED THERE WERE CASES OF HEMATOMA, ANEURYSM, PSEUDO-ANEURYSM, TEMPORARY PARALYSIS OF THE DIAPHRAGM, ATRIAL FLUTTER OR SUPRAVENTRICULAR TACHYCARDIA, TAMPONADE AND STROKE. THE DISPOSITION OF THE PRODUCT IS NOT KNOWN. 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
    1398986 ARCTIC FRONT ADVANCE PRO CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP AFAPRO28 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R