BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 7046723 · Received November 20, 2017

    Report

    Report Number
    3002648230-2017-00632
    Event Type
    Injury
    Date Received
    November 20, 2017
    Date of Event
    January 1, 2017
    Report Date
    November 20, 2017
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010/S015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONTINUATION OF MEDICAL DEVICES: ACHIEVE MAPPING CATHETER. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC PATIENT OR 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. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE MODEL FAMILY, AS THERE IS NO SPECIFIC MODEL LISTED. THE GENDER OF THE BASELINE CHARACTERISTICS IS MALE AND THE BASELINE AGE IS (B)(6). OF NOTE, MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT LOT NUMBERS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. REFERENCED ARTICLE: CHROMOSOME 4Q25 VARIANTS AND RECURRENCE AFTER SECOND-GENERATION CRYOBALLOON ABLATION IN PATIENTS WITH PAROXYSMAL ATRIAL FIBRILLATION.¿ INTERNATIONAL JOURNAL OF CARDIOLOGY 244 (2017) 151¿157. HTTP://DX.DOI.ORG/10.1016/J.IJCARD.2017.06.046.

    Description of Event or Problem · 1

    THE LITERATURE PUBLICATION REPORTS THE FOLLOWING PATIENT COMPLICATION WHILE USING A CRYOABLATION BALLOON/SHEATH CATHETER/MAPPING CATHETER: THERE WAS ONE PATIENT WHO EXPERIENCED CARDIAC TAMPONADE, WHICH REQUIRED PERICARDIOCENTESIS. THERE WERE THREE (3) PATIENTS WHO EXPERIENCED PHRENIC NERVE INJURY (PNI) WHICH REMAINED ON THE DAY AFTER THE PROCEDURE, 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 NUMBERS. THE STATUS/LOCATION OF THE CRYOBALLOON/SHEATH CATHETER/MAPPING CATHETER IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823621 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 64 YR Hospitalization| L| R