BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 6099370 · Received November 14, 2016

    Report

    Report Number
    3002648230-2016-00482
    Event Type
    Injury
    Date Received
    November 14, 2016
    Date of Event
    October 20, 2016
    Report Date
    October 20, 2016
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010/S015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE AND DATA FILES WERE RETURNED AND ANALYZED. THE DATA FILES SHOWED THAT AT LEAST FOUR INJECTIONS WERE PERFORMED WITH THE CATHETER ON THE DATE OF THE EVENT. THE DATA FILES SHOWED THAT A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED A HIGH LEVEL OF REFRIGERANT FLOW AND STOPPED THE INJECTION (#(B)(4)). VISUAL INSPECTION OF THE CATHETER SHOWED THAT THE DEVICE WAS INTACT WITH NO APPARENT ISSUES. THE CATHETER PASSED THE PERFORMANCE TEST AND ELECTRICAL INTEGRITY AS PER SPECIFICATION. ALSO, IMPEDANCE WAS WITHIN SPECIFICATION AND THE INFLATION WERE SUSTAINED FOR MORE THAN TWO MINUTES. DISSECTION AND PRESSURE TESTING DID NOT SHOW ANY LEAKS ALONG THE VACUUM LINE. IN CONCLUSION, THE CATHETER PASSED THE INSPECTION AS PER SPECIFICATION. ALSO, THIS WAS A CLINICAL ISSUE ENCOUNTERED DURING THE PROCEDURE.

    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

    DATA FILES DEMONSTRATED A SYSTEM NOTICE UNRELATED TO THE REPORTED ADVERSE EVENT. PHYSICAL PRODUCT ANALYSIS IS PENDING.

    Additional Manufacturer Narrative · 1

    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, A PERICARDIAL EFFUSION WAS DIAGNOSED APPROXIMATELY ELEVEN MINUTES FOLLOWING THE FIRST FREEZE OF THE LEFT PULMONARY VEIN. THE CASE WAS ABORTED AS HYPOTENSION WAS OBSERVED AND A PERICARDIOCENTESIS WAS PERFORMED. AFTER, THE PATIENTS VITALS STABILIZED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL FOUR DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751081 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF284 73912

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R 4FC12 SHEATH, (B)(4) MAPPING CATHETER