BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC FRONT CARDIAC CRYOABLATION CATHETER

    MDR report key: 5476873 · Received March 3, 2016

    Report

    Report Number
    3002648230-2016-00077
    Event Type
    Malfunction
    Date Received
    March 3, 2016
    Date of Event
    February 4, 2016
    Report Date
    May 3, 2016
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K123591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT SUMMARY: DATA FILE ANALYSIS SHOWED AT LEAST EIGHT INJECTIONS WERE PERFORMED WITH NON-RETURNED CATHETER 2AF284 / 29910-47 WITHOUT ANY ISSUE. IN CONCLUSION, INVESTIGATION COULD NOT BE COMPLETED DUE TO THE PRODUCT NOT BEING RETURNED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRYOABLATION PROCEDURE WHILE THE SHEATH WAS BEING ADVANCED INTO THE LEFT ATRIUM, AIR WAS CONFIRMED TO BE LEAKING FROM THE SHEATH. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133491 ARCTIC FRONT CARDIAC CRYOABLATION CATHETER CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12 98879

    Patients

    Seq Age Sex Outcome Treatment
    1