BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISUAL ICE CRYOABLATION SYSTEM

    MDR report key: 4940273 · Received July 24, 2015

    Report

    Report Number
    3004462490-2015-00016
    Event Type
    Injury
    Date Received
    July 24, 2015
    Date of Event
    June 25, 2015
    Report Date
    June 26, 2015
    Manufacturer
    GALIL MEDICAL INC.
    Product Code
    GEH
    PMA / PMN Number
    K113860
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE NEEDLES NOR THE SYSTEM WERE RETURNED FOR ANALYSIS. NO INVESTIGATION OF THE NEEDLES OR SYSTEM IS WARRANTED AS THE REPORTED ISSUE DOES NOT IMPLY A FAILURE OF GALIL MEDICAL'S PRODUCTS. THIS EVENT REPRESENTS A KNOWN INHERENT RISK OF A LUNG CRYOABLATION PROCEDURE AND IS IDENTIFIED IN THE LABELING AS A POTENTIAL ADVERSE EVENT.

    Additional Manufacturer Narrative · 1

    GALIL MEDICAL RECEIVED ADDITIONAL FOLLOWUP INFORMATION ABOUT THE SUBJECT. THE SUBJECT WAS RE-HOSPITALIZED DUE TO AN EPISODE OF HEMOPTYSIS. MEDICAL ASSESSMENT DETERMINED THAT THE SYMPTOMS AND PRESENTATION WERE CONSISTENT WITH THE PLACEMENT OF THE STENT ON THE SUBJECT'S PREVIOUS ADMISSION AND NOT RELATED TO THE CRYOABLATION DEVICE/PROCEDURE. THE SUBJECTS SYMPTOMS IMPROVED AND THE SUBJECT WAS DISCHARGED WITH HOME CARE SERVICES.

    Description of Event or Problem · 1

    FOLLOWUP INFORMATION ABOUT THE PATIENT RECEIVED: SUBJECT WAS SUBSEQUENTLY RE-HOSPITALIZED ON (B)(6) 2015 DUE TO AN EPISODE OF HEMOPTYSIS. SYMPTOMS IMPROVED DURING HOSPITAL STAY. UPON MEDICAL ASSESSMENT, HER SYMPTOMS AND PRESENTATION WERE DETERMINED TO BE CONSISTENT WITH THE PLACEMENT OF THE STENT ON HER LAST ADMISSION. SUBJECT DISCHARGED (B)(6) 2015 WITH HOME CARE SERVICES.

    Description of Event or Problem · 1

    A GALIL MEDICAL CRA RECEIVED A CALL ON THE SAE HOTLINE AT 6:22AM CENTRAL ON (B)(6) 2015. THE CLINICAL STUDY MANAGER AT (B)(6) HOSPITAL REPORTED A SAE IN SUBJECT (B)(6). SUBJECT UNDERWENT A CRYOABLATION AS PART OF THE SOLSTICE STUDY ON (B)(6) 2015 AND POST-PROCEDURE, A SMALL LEFT-SIDED PNEUMOTHORAX WAS NOTED. A CHEST TUBE WAS PLACED WHICH PROLONGED THE HOSPITALIZATION. (B)(6) REPORTED THEY ARE CATEGORIZING THE EVENT AS A CTCAE GRADE 2. SUBJECT IS STILL IN HOSPITAL THUS NO INFORMATION IS AVAILABLE AT THE TIME OF THIS SUBMISSION ABOUT SAE RESOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481981 VISUAL ICE CRYOABLATION SYSTEM CRYOSURGICAL DEVICE AND ACCESSORIES GEH GALIL MEDICAL INC. FPRCH6000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention