BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 6727269 · Received July 20, 2017

    Report

    Report Number
    3002648230-2017-00372
    Event Type
    Injury
    Date Received
    July 20, 2017
    Date of Event
    June 29, 2017
    Report Date
    August 10, 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

    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

    EVENT SUMMARY: THE PATIENT DATA FILES SHOWED AT LEAST EIGHT APPLICATIONS WERE PERFORMED WITH 2AF284/61719-62 WITH NO ISSUES ON THE DATE OF THE EVENT. CLINICAL ISSUES (PHRENIC NERVE PALSY (PNP)) WAS ENCOUNTERED DURING THE PROCEDURE. THE BALLOON CATHETER 2AF284/61719-62 WAS NOT RETURNED FOR INVESTIGATION. NO PRODUCT MALFUNCTION REPORTED. IN CONCLUSION, THIS IS A CLINICAL ISSUE (PHRENIC NERVE PALSY) ENCOUNTERED DURING THE CASE. THE CATHETER WAS NOT RETURNED FOR INVESTIGATION. 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, COMPOUND MUSCLE ACTION POTENTIAL (CMAP) CONFIRMED THAT THE PHRENIC NERVE MOTION WAS WEAKENED DURING THE RIGHT SUPERIOR PULMONARY VEIN ABLATION. DOUBLE-STOP WAS PERFORMED BUT PHRENIC NERVE PARALYSIS (PNP) OCCURRED. ALTHOUGH PACING FAILURE OCCURRED IN THE SUPERIOR VENA CAVA, ADDITIONAL ABLATION WAS PERFORMED. THE CASE WAS COMPLETED WITH CRYO. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT A STEROID WAS GIVEN TO THE PATIENT AS INTERVENTION. THE PATIENT RECOVERED WITH NO EXTENDED HOSPITAL STAY AND WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507627 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF284 61719

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention