BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE PRO CARDIAC CRYOABLATION CATHETER

    MDR report key: 10362353 · Received August 4, 2020

    Report

    Report Number
    3002648230-2020-00393
    Event Type
    Injury
    Date Received
    August 4, 2020
    Date of Event
    July 14, 2020
    Report Date
    August 4, 2020
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010/S015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DATA FILES WERE RETURNED AND ANALYZED. THE FILES SHOWED SYSTEM NOTICE #50028 ¿THERE IS A PROBLEM WITH THE INJECTION PROCESS¿ IN APPLICATIONS 1 AND 2 AND SYSTEM NOTICE #50012 ¿THE REFRIGERANT DELIVERY PATH IS OBSTRUCTED¿ IN THE BEGINNING OF THE APPLICATION 4 WITH A NON-RETURNED BALLOON CATHETER 2AF284 WITH LOT NUMBER 02424-37. THE FILES SHOWED AT LEAST 12 APPLICATIONS WERE PERFORMED WITH THIS CATHETER ON THE DATE OF THE EVENT. A CLINICAL ISSUE (PHRENIC NERVE PALSY (PNP)) OCCURRED DURING THE PROCEDURE. IN CONCLUSION, THE BALLOON CATHETER WAS NOT RETURNED FOR INVESTIGATION. THERE IS NO INDICATION OF A MALFUNCTION OF THE BALLOON CATHETER RELATED TO THE ADVERSE EVENT. 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 CRYOABLATION PROCEDURE, PHRENIC NERVE PALSY (PNP) OCCURRED, AND THE DOUBLE STOP TECHNIQUE WAS PERFORMED. THE PNP WAS 'ALMOST RECOVERED' AT THE END OF THE PROCEDURE. THE CASE WAS COMPLETED WITH RADIOFREQUENCY. THE PHRENIC NERVE RESPONSE WAS WEAKER THAN IT WAS INITIALLY. THE PATIENT WOULD BE MONITORED. IT WAS NOTED THE PNP HAD NOT RECOVERED AT DISCHARGE, BUT THE PATIENT WAS ASYMPTOMATIC. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826109 ARCTIC FRONT ADVANCE PRO CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP AFAPRO28 02424

    Patients

    Seq Age Sex Outcome Treatment
    1 Other