BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 5180597 · Received October 27, 2015

    Report

    Report Number
    3002648230-2015-00379
    Event Type
    Malfunction
    Date Received
    October 27, 2015
    Date of Event
    August 12, 2015
    Report Date
    October 20, 2015
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010/S015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVENT SUMMARY: THE DEVICE, BALLOON CATHETER 2AF283 WITH LOT # 52126-26 WAS RETURNED AND ANALYZED. UPON VISUAL INSPECTION OF CATHETER, ANALYSIS SHOWED BLOOD INSIDE THE BALLOONS. SMART CHIP VERIFICATION INDICATED THE CATHETER WAS USED FOR FIVE INJECTIONS. ADDITIONALLY, DURING DISSECTION AND PRESSURE TESTING, A GUIDE WIRE LUMEN KINK AND BREACHED WERE SHOWN AT 1.37 INCHES PROXIMAL FROM THE TIP AND TWO MORE KINKS ON SHAFT AND GUIDE WIRE LUMEN 2.62 AND 3.27 INCHES FROM THE TIP. IN CONCLUSION, THE REPORTED SYSTEM NOTICE #50005 ¿FLUID IN CATHETER¿ ISSUE WAS CONFIRMED THROUGH TESTING. THE CATHETER FAILED THE INSPECTION DUE TO A GUIDE WIRE LUMEN KINK AND BREACH. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE A SYSTEM NOTICE INDICATING THE SAFETY SYSTEM DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION OCCURRED. THE BALLOON CATHETER WAS REPLACED. IT WAS FURTHER REPORTED THAT AFTER REPLACING THE FIRST BALLOON CATHETER, THE REPLACEMENT CATHETER COULD NOT BE INSERTED INTO THE SHEATH. THE SHEATH WAS ALSO REPLACED. THE PROCEDURE WAS COMPLETED WITH CRYO. THE BALLOON CATHETER SUBSEQUENTLY TESTED OUT OF SPECIFICATION UPON MANUFACTURER'S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712244 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF283 52126

    Patients

    Seq Age Sex Outcome Treatment
    1