BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 6907450 · Received October 2, 2017

    Report

    Report Number
    3002648230-2017-00545
    Event Type
    Injury
    Date Received
    October 2, 2017
    Date of Event
    September 7, 2017
    Report Date
    November 27, 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 FILE ANALYSIS SHOWED SIX INJECTIONS WERE PERFORMED WITH CATHETER 2AF284 / 31134-75 WITHOUT ANY ISSUES OR SYSTEM NOTICES. FAILURE FILE CONFIRMED SYSTEM NOTICE (#50002) A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SYSTEM DETECTED AN ELECTRICAL COMPONENT FAILURE. ADDITIONALLY, (#50032) A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED A COMPROMISED OUTER VACUUM. THE BALLOON CATHETER WAS NOT RETURNED. THIS IS A CLINICAL ISSUE (ACUTE GASTRIC ATONY/GASTROPARESIS) ENCOUNTERED POST PROCEDURE. NO PRODUCT MALFUNCTION REPORTED. IN CONCLUSION, THE REPORTED GASTROPARESIS ISSUE CANNOT BE CONFIRMED THROUGH DATA ANALYSIS. THE BALLOON CATHETER WAS NOT RETURNED. CLINICAL ISSUE (ACUTE GASTRIC ATONY/GASTROPARESIS) ENCOUNTERED POST PROCEDURE. 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 ESOPHAGUS TEMPERATURE DROPPED BELOW TWENTY DEGREES, AND SINGLE STOP WAS PERFORMED IMMEDIATELY. AFTER SOME TIME, THE NEXT ABLATION WAS PERFORMED, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE. HOWEVER, ONE DAY POST PROCEDURE, THE PATIENT VOMITED AND COMPLAINED OF ABDOMINAL DISTENSION. ACUTE GASTRIC ATONY WAS THEN DIAGNOSED VIA GASTROFIBERSCOPE. THE PATIENT FASTED, AS DIRECTED BY THE PHYSICIAN. TREATMENT FOR GASTRIC ATONY WAS THEN PERFORMED. A FEW DAYS LATER, THE GASTROFIBERSCOPE SHOWED THAT THERE WAS GRADUAL GASTRIC MOVEMENT, AND THE PATIENT'S GASTRIC DILATATION RESOLVED. THE PATIENT'S FASTING WAS DISCONTINUED, AND THE PATIENT STARTED RICE PORRIDGE WITH LIMITED FOOD CHOICES. IT WAS NOTED THAT THE PATIENT WAS IN THE HOSPITAL FOR TWO WEEKS, AND WAS THEN DISCHARGED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687276 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF284 81567

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R