BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 6720049 · Received July 17, 2017

    Report

    Report Number
    3002648230-2017-00368
    Event Type
    Injury
    Date Received
    July 17, 2017
    Date of Event
    June 26, 2017
    Report Date
    August 2, 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

    EVENT SUMMARY: THE PATIENT DATA FILES SHOWED THIRTEEN INJECTIONS WERE PERFORMED WITH CATHETER 2AF284 / 61636-90 AND SHOWED INFLATIONS WERE NOT SUSTAINED AT MANY INJECTIONS. CLINICAL ISSUE (BLOOD PRESSURE DECLINED, PERICARDIAL EFFUSION AND CARDIAC TAMPONADE) WERE ENCOUNTERED DURING THE PROCEDURE. THE BALLOON CATHETER 2AF283/61636 WAS NOT RETURNED FOR INVESTIGATION. IN CONCLUSION, THIS WAS A CLINICAL ISSUE (BLOOD PRESSURE DECLINED, PERICARDIAL EFFUSION AND CARDIAC TAMPONADE) ENCOUNTERED DURING THE PROCEDURE. NO INDICATION OF PRODUCT MALFUNCTION. THE BALLOON 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, THE SHEATH AND MAPPING CATHETER WERE MANIPULATED IN ORDER TO REACH THE RIGHT MIDDLE OF THE RIGHT INFERIOR PULMONARY VEIN (RIPV) AND IT WAS OBSERVED THAT THE BLOOD PRESSURE DECLINED, THERE WAS A PERFORATION TO THE ENDOCARDIUM AND DID NOT RETURN TO NORMAL. A PERICARDIAL EFFUSION WAS THEN CONFIRMED BY ECHOCARDIOGRAPHY. THE PRODUCTS WERE REMOVED FROM THE BODY AND PERICARDIAL DRAINAGE WAS PERFORMED. ALSO, THE PATIENT HAD A CARDIAC TAMPONADE. THE ANTICOAGULANT WAS NEUTRALIZED AND A BLOOD TRANSFUSION WAS GIVEN. THE PATIENT WAS TRANSFERRED TO A DIFFERENT FACILITY AND THE PATIENT'S CONDITION WAS MONITORED FOR POSSIBLE CARDIAC SURGERY. THE CASE WAS ABORTED AND THE PATIENT WAS NOT UNDER GENERAL ANESTHESIA. ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT WAS ADMITTED FOR APPROXIMATELY ONE WEEK, WAS DEEMED STABLE AND 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
    499149 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF284 61636

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R