BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICEROD CX 90° NEEDLE/VL

    MDR report key: 9107101 · Received September 23, 2019

    Report

    Report Number
    9616793-2019-00057
    Event Type
    Injury
    Date Received
    September 23, 2019
    Report Date
    September 23, 2019
    Manufacturer
    GALIL MEDICAL LTD
    Product Code
    GEH
    UDI-DI
    07290104830587
    PMA / PMN Number
    K152133
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS WERE MADE TO GATHER ADDITIONAL INFORMATION REGARDING THIS CASE FROM THE PHYSICIAN UNSUCCESSFULLY. TO DATE, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO DEVICE MALFUNCTION WAS REPORTED. THE DEVICE AS A CONTRIBUTING FACTOR TO THIS EVENT CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED. RENAL FAILURE IS A KNOWN POTENTIAL ADVERSE EVENT TO CRYOABLATION THERAPY AND IS LISTED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A RENAL CRYOABLATION CASE WITH 4 NEEDLES TOTAL. THE PATIENT SUBSEQUENTLY WENT INTO RENAL FAILURE AND REQUIRED DIALYSIS. THE TUMOR WAS LOCATED NEAR THE COLLECTING SYSTEM AND THE UROLOGIST PLACED A STENT PRIOR TO THE CASE. THE TREATING AND CONSULTING PHYSICIAN REVIEWED THE CASE AND FELT THAT THE TREATMENT HAD BEEN APPROPRIATE. THIS EVENT WAS REPORTED TO THE BTG CLINICAL SPECIALIST DURING AN UNRELATED CASE. NO DEVICE MALFUNCTION WAS REPORTED TO BTG AT THE TIME OF THE INITIAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898851 ICEROD CX 90° NEEDLE/VL CRYOABLATION NEEDLE GEH GALIL MEDICAL LTD FPRPR3533, FPRPR3602 NO INFORMATION 07290104830587

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention