BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSENSE

    MDR report key: 17110019 · Received June 12, 2023

    Report

    Report Number
    3008797959-2019-00001
    Event Type
    Injury
    Date Received
    June 12, 2023
    Date of Event
    February 7, 2018
    Report Date
    January 17, 2019
    Manufacturer
    ICECURE MEDICAL LTD.
    Product Code
    GEH
    PMA / PMN Number
    K102360
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FORM ABONDANCE OF CAUTION AFTER A REVIEW OF THE MAUDE DATABASE DID NOT FIND THE ORIGINAL REPORT SUBMITTED ON 17 JAN 2019, IT WAS DECIDED TO RESUBMIT THE ORIGINAL MDR. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. THERE WERE NO DEVICE MALFUNCTIONS REPORTED AT THE TIME OF THE CRYOABLATION PROCEDURE. THE REPORT OF URETEROPELVIC JUNCTION OBSTRUCTION SCAR IS CONSISTENT WITH POTENTIAL SIDE EFFECTS OF CRYOABLATION INJURY, IS A KNOWN RISK ASSOCIATED WITH A CRYOABLATION PROCEDURE AND IS INCLUDED IN THE RISK DOCUMENTS AND PRODUCT LABELING. THE EVENT COULD NOT BE DETERMINED AS RELATED TO THE USE OF THE DEVICE.

    Description of Event or Problem · 0

    THE COMPANY WAS INFORMED ON DATE: 20-DEC 2018 OF THE FOLLOWING EVENT: FOLLOWING UNCOMPLICATED RENAL CRYOABLATION PROCEDURE (B)(6) 2018), DURING FOLLOW UP PERIOD ON CLINIC VISIT, DATED (B)(6) 2018. A CT SHOWED URETEROPELVIC JUNCTION (UPJ) OBSTRUCTION AND SCAR CHANGES NEAR THE LT. URETER THAT CAUSED HYDRONEPHROSIS OF LT. KIDNEY. PATIENT WAS HOSPITALIZED FOR FURTHER EVALUATION AND ADDITIONAL EXAMS. IN ATTEMPT TO PREVENT PARAMENT INJURY NEPHROSTOMY WAS INSERTED, YET RENAL FUNCTION WAS FOUND IMPAIRED PER DSMA (DIMERCAPTOSUCCINIC ACID) SCAN. PROGRESS NOTES IN THE MEDICAL RECORDS INDICATE THE UPJ OBSTRUCTION IS LIKELY RELATED TO THE CRYOABLATION. THE PATIENT IS CANDIDATE FOR RADICAL NEPHRECTOMY. THE PATIENT HAD PARIAL NEPHRECTOMY ON: (B)(6) 2019. *FOR ABONDANCE OF CAUTION AFTER A REVIEW OF THE MAUDE DATABASE, IT WAS DECIDED TO RESUBMIT THE ORIGINAL MDR AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606787 PROSENSE CRYOSURGICAL UNIT AND ACCESSORIES GEH ICECURE MEDICAL LTD. FAP7200000 CRYOPROBE

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Disability| H| R