BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESICE CRYOABLATION SYSTEM

    MDR report key: 3934398 · Received June 27, 2014

    Report

    Report Number
    9616793-2014-00009
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    August 28, 2013
    Report Date
    June 6, 2014
    Manufacturer
    GALIL MEDICAL LTD.
    Product Code
    OCL
    PMA / PMN Number
    K060390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR INVESTIGATION AND NO MALFUNCTIONS OR ISSUES WITH THE DEVICE WAS REPORTED. THIS ADVERSE EVENT WAS COLLECTED AS PART OF A CLINICAL STUDY. PAIN, NAUSEA, AND FEVER ARE KNOWN POTENTIAL ADVERSE EFFECTS FROM CRYOABLATION PROCEDURES AND ARE DOCUMENTED AS SUCH IN THE PRODUCT IFU AND USER MANUAL. THE PATIENT WAS TREATED AND DISCHARGED TWO DAYS FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    SUBJECT 1R04 IS A (B)(6) FEMALE ENROLLED IN THE (B)(6) WHO HAD CT-GUIDED RIGHT RENAL CRYOABLATION UNDER CONSCIOUS SEDATION AND WITHOUT COMPLICATIONS ON (B)(6) 2013. ACCORDING TO THE POST-CRYOABLATION NOTES, THE PATIENT EXPERIENCED ABDOMINAL PAIN LEVEL 9/10 ALONG WITH NAUSEA, TIGHTNESS AND UPPER ABDOMINAL AREA, WEAKNESS, AND FEELING HOT. SHE WAS GIVEN MEDICATION FOR THESE SYMPTOMS. PROCEDURE WAS (B)(6) 2013 AND PATIENT WAS DISCHARGED (B)(6) 2013. THIS IS CONSIDERED AN SAE BECAUSE IT EXTENDED THE EXISTING HOSPITALIZATION. THIS SAE WAS NOTED DURING A MONITORING VISIT AND REVIEW OF THE PROCEDURE AND POST-PROCEDURE NOTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375758 PRESICE CRYOABLATION SYSTEM CRYOSURGICAL UNIT, ACCESSORIES OCL GALIL MEDICAL LTD. FPRCH2047

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization