BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT CARDIAC CRYOABLATION CATHETER

    MDR report key: 7264389 · Received February 12, 2018

    Report

    Report Number
    3002648230-2018-00089
    Event Type
    Injury
    Date Received
    February 12, 2018
    Date of Event
    January 1, 2016
    Report Date
    February 12, 2018
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. 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 BASELINE GENDER/AGE OF THE PATIENTS REPRESENTED IN THE ARTICLE IS MALE/61 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. REFERENCED ARTICLE: ¿INCIDENCE AND PREDICTORS OF COMPLICATIONS DURING CRYOBALLOON PULMONARY VEIN ISOLATION FOR ATRIAL FIBRILLATION.¿ J AM HEART ASSOC. 2016;5:E003724 DOI: 10.1161/JAHA.116.003724. INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE LITERATURE PUBLICATION REPORTS THE FOLLOWING PATIENT COMPLICATIONS WHILE USING A CRYOABLATION BALLOON: THERE WERE 49 PATIENTS WHO EXPERIENCED TRANSIENT/PERSISTENT PHRENIC NERVE INJURY (PNI) DURING/AFTER THE PROCEDURE; ALL OF WHICH RESOLVED WITHIN 48 DAYS OF THE PROCEDURE. THERE WERE THREE (3) PATIENTS WHO EXPERIENCED ¿SYMPTOMATIC PERICARDIAL EFFUSION,¿ ALL OF WHICH RESOLVED WITHIN SEVEN (7) DAYS. ONE OF THESE PATIENTS DID REQUIRE MONITORING OVERNIGHT IN THE HOSPITAL. THERE WAS ONE PATIENT WHO PRESENTED TO THE EMERGENCY DEPARTMENT AT SIX (6) DAYS POST-OP, WITH DEEP VEN THROMBOSIS. THE PATIENT¿S MEDICATIONS WERE CHANGED, AND AT THE TWO-MONTH FOLLOW UP VISIT, THE SYMPTOMS WERE RESOLVED. THERE WAS ALSO ONE PATIENT WHO HAD ¿PROLONGED BLEEDING FROM THE GROIN PUNCTURE SITE.¿ IT WAS FOUND THAT THERE WAS A PSEUDOANEURYSM AND ARTERIOVENOUS FISTULA THAT WAS SURGICALLY REPAIRED AT DAY FIVE (5) OF POST-OP. 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 CATHETER/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
    108042 ARCTIC FRONT CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF282

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R