BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 7898383 · Received September 21, 2018

    Report

    Report Number
    3002648230-2018-00675
    Event Type
    Malfunction
    Date Received
    September 21, 2018
    Date of Event
    August 30, 2018
    Report Date
    November 6, 2018
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010/S015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DATA FILES AND BALLOON CATHETER WERE RETURNED AND ANALYZED. THE DATA FILES SHOWED TWELVE APPLICATIONS WERE PERFORMED WITH BALLOON CATHETER 2AF283 LOT NUMBER 88200-135. ADDITIONALLY, THE DATA FILES DID NOT SHOW ANY SYSTEM NOTICES. FIFTEEN APPLICATIONS WERE PERFORMED WITH BALLOON CATHETER 2AF283 LOT NUMBER 88200, AND SYSTEM NOTICE 50012 ¿THE REFRIGERANT DELIVERY IS OBSTRUCTED¿ WAS CONFIRMED ON THE SECOND APPLICATION. VISUAL INSPECTION OF REPORTED BALLOON CATHETER 2AF284 LOT 88200-31 SHOWED THAT THE CATHETER WAS INTACT WITH NO APPARENT ISSUES AND THE LUER WAS NOT BROKEN. THE REPORTED BALLOON CATHETER PASSED THE PERFORMANCE TEST AND ELECTRICAL INTEGRITY AS PER SPECIFICATION, AND IMPEDANCE WAS ALSO WITHIN SPECIFICATION. IN CONCLUSION, THE REPORTED BROKEN LUER ISSUE WAS NOT CONFIRMED THROUGH RETURNED PRODUCT ANALYSIS AND DATA ANALYSIS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE BALLOON CATHETER LUER HAD BROKEN. THE BALLOON CATHETER WAS REPLACED AND THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740558 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF283 88200

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR