BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 6836016 · Received August 31, 2017

    Report

    Report Number
    3002648230-2017-00488
    Event Type
    Injury
    Date Received
    August 31, 2017
    Date of Event
    August 7, 2017
    Report Date
    September 19, 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 AT LEAST SEVEN APPLICATIONS WERE PERFORMED WITH CATHETER 2AF284 / 12130-80 ON THE DATE OF THE EVENT WITH NO SYSTEM ISSUE. THIS CASE IS A CLINICAL ISSUE (ST ELEVATION OCCURRED AND RECOVERED, NO AIR WAS INTRODUCED INTO THE BODY. AFTER THE PROCEDURE, THE PATIENT HAD A LOSS OF CONSCIOUSNESS AND SPASM. THE PATIENT CURRENTLY PARALYZED ON THE LEFT SIDE OF THE BODY. A NEW BRAIN INFARCTION WAS IDENTIFIED BY COMPUTERIZED TOMOGRAPHY (CT) SCAN. IT WAS NOTED THAT THE BRAIN INFARCTION COULD POSSIBLY BE DUE TO THROMBIN). THE BALLOON CATHETER WAS NOT RETURNED. IN CONCLUSION, THIS IS A CASE RELATED TO A CLINICAL ISSUE (ST ELEVATION, LOSS OF CONSCIOUSNESS, SPASM, PARALYZED ON THE LEFT SIDE OF THE BODY, AND THE INFARCTION DUE TO THROMBIN.) THE BALLOON CATHETER WAS NOT RETURNED. THE REPORTED ISSUES CLINICAL ISSUES WERE NOT CONFIRMED THROUGH DATA ANALYSIS. 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, FOLLOWING ASPIRATION, ST ELEVATION OCCURRED BUT RECOVERED AND IT WAS CONFIRMED NO AIR WAS INTRODUCED INTO THE BODY VIA FLUOROSCOPY. WHEN THE BALLOON CATHETER WAS INSERTED INTO THE SHEATH FOR AN ABLATION, RESISTANCE WAS ENCOUNTERED. THE CASE WAS COMPLETED WITH CRYO. AFTER THE PROCEDURE WAS COMPLETED THE PATIENT HAD A LOSS OF CONSCIOUSNESS AND SPASM. TREATMENT WAS ADMINISTERED AND THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL TO UNDERGO HYPERBARIC OXYGEN THERAPY. IT WAS NOTED THAT THE SPASM OCCURRED ONE TIME AT NIGHT POST PROCEDURE. THE PATIENT REGAINED CONSCIOUSNESS BUT CURRENTLY PARALYZED ON THE LEFT SIDE OF THE BODY. A NEW BRAIN INFARCTION WAS IDENTIFIED BY COMPUTERIZED TOMOGRAPHY (CT) SCAN. IT WAS NOTED THAT THE BRAIN INFARCTION COULD POSSIBLY BE DUE TO THROMBIN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, FOLLOWING ASPIRATION, ST ELEVATION OCCURRED BUT RECOVERED AND IT WAS CONFIRMED NO AIR WAS INTRODUCED INTO THE BODY VIA FLUOROSCOPY. WHEN THE BALLOON CATHETER WAS INSERTED INTO THE SHEATH FOR AN ABLATION, RESISTANCE WAS ENCOUNTERED. THE CASE WAS COMPLETED WITH CRYO. AFTER THE PROCEDURE WAS COMPLETED THE PATIENT HAD A LOSS OF CONSCIOUSNESS AND SPASM. TREATMENT WAS ADMINISTERED AND THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL TO UNDERGO HYPERBARIC OXYGEN THERAPY. IT WAS NOTED THAT THE SPASM OCCURRED ONE TIME AT NIGHT POST PROCEDURE. THE PATIENT REGAINED CONSCIOUSNESS BUT CURRENTLY PARALYZED ON THE LEFT SIDE OF THE BODY. A NEW BRAIN INFARCTION WAS IDENTIFIED BY COMPUTERIZED TOMOGRAPHY (CT) SCAN. IT WAS NOTED THAT THE BRAIN INFARCTION COULD POSSIBLY BE DUE TO THROMBIN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613605 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF284 12130

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R