BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNIT, CRYOSURGICAL, ACCESSORIES

    MDR report key: 10105337 · Received June 1, 2020

    Report

    Report Number
    2134265-2020-07202
    Event Type
    Death
    Date Received
    June 1, 2020
    Date of Event
    January 1, 2020
    Report Date
    July 16, 2020
    Manufacturer
    GALIL MEDICAL LTD.
    Product Code
    GEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATES OR CORRECTION TO THE FOLLOWING FIELDS: B5: DESCRIBE EVENT OR PROBLEM. H6: PATIENT CODES. D2: ADDITIONAL PRO CODE: OCL. THIS COMPLAINT IS DERIVED FROM THE LITERATURE ARTICLE TITLED: "SAFAVY, S., JABAJI, R. B., LU, S. M., SLEZAK, J. M., COSMATOS, H. A., WILLIAMS, S. G., & FINLEY, D. S. (2019). SALVAGE CRYOABLATION FOR RADIORECURRENT PROSTATE CANCER: INITIAL EXPERIENCE AT A REGIONAL HEALTH CARE SYSTEM. THE PERMANENTE JOURNAL." PERM J 2019;23:18 TO 153, HTTPS://DOI.ORG/10.7812/TPP/18-153 PUBLICATION DATE: JAN 2020 - DEFAULT TO FIRST DAY OF THE MONTH, 01 JAN 2020.

    Additional Manufacturer Narrative · 0

    UPDATES OR CORRECTION TO THE FOLLOWING FIELDS: G1: MANUFACTURER INFORMATION. D3: MANUFACTURER ADDRESS. THIS COMPLAINT IS DEIVED FROM THE LITERATURE ARTICLE TITLED: "SAFAVY, S., JABAJI, R. B., LU, S. M., SLEZAK, J. M., COSMATOS, H. A., WILLIAMS, S. G., & FINLEY, D. S. (2019). SALVAGE CRYOABLATION FOR RADIORECURRENT PROSTATE CANCER: INITIAL EXPERIENCE AT A REGIONAL HEALTH CARE SYSTEM. THE PERMANENTE JOURNAL." PERM J 2019;23:18 TO 153, HTTPS://DOI.ORG/10.7812/TPP/18-153 PUBLICATION DATE: JAN 2020 - DEFAULT TO FIRST DAY OF THE MONTH, 01 JAN 2020. THE REPORTED ADVERSE EVENT IS IDENTIFIED IN THE PRODUCT LABELLING AS A POTENTIAL ADVERSE EVENT, AND THE ASSOCIATED RISKS ARE COVERED IN THE PRODUCT'S RISK DOCUMENTATION. MEDICAL REVIEW SHOWS THAT THE HARM IS ANTICIPATED, AND THE ASSOCIATED SEVERITY ARE COVERED IN THE EXISTING LABELLING.

    Description of Event or Problem · 0

    IT WAS REPORTED IN PUBLISHED LITERATURE THAT, DURING A PROSTATE CRYOABLATION PROCEDURE, A PATIENT DIED FROM A PULMONARY EMBOLISM. THE PUBLISHED LITERATURE ARTICLE: "SALVAGE CRYOABLATION FOR RADIORECURRENT PROSTATE CANCER: INITIAL EXPERIENCE AT A REGIONAL HEALTH CARE SYSTEM" BY SAFAVY. ET AL. 2019 IS A RETROSPECTIVE, SINGLE-CENTRE REVIEW OF 75 PATIENTS WHO RECEIVED CRYOABLATION TREATMENT FOR PROSTATE CANCER WITH EITHER GALIL (GALIL MEDICAL) OR ENDOCARE (ENDOCARE/HEALTHTRONICS INC). THE FOLLOWING COMPLICATIONS WERE REPORTED: 2 RECTAL FISTULAS, (2.7%), 5 URETHRAL STRICTURES (6.7%), 19 PATIENTS WITH STRESS URINARY INCONTINENCE REQUIRING AT LEAST 1 PAD PER DAY (25.3%), AND 1 DEATH CAUSED BY A PULMONARY EMBOLISM (1.3%). THE REPORTED DEATH EVENT WAS NOTED TO HAVE OCCURED PERIOPERATIVELY IN THE ARTICLE DISCUSSION. NO DEVICE MALFUNCTIONS WERE REPORTED IN THE ARTICLE. THE COMPLICATIONS DESCRIBED ARE NOT NOTED TO BE SERIOUS IN NATURE NOR HAVE REQUIRED INTERVENTION TO PREVENT SERIOUS INJURY. MEDICAL REVIEW NOTED THAT THE HARMS AND THEIR ASSOCIATED SEVERITY ARE COVERED UNDER THE EXISTING LABELLING FOR CRYOABLATION PRODUCTS.

    Description of Event or Problem · 0

    IT WAS REPORTED IN PUBLISHED LITERATURE THAT, DURING A PROSTATE CRYOABLATION PROCEDURE, A PATIENT DIED FROM A PULMONARY EMBOLISM. THE PUBLISHED LITERATURE ARTICLE: "SALVAGE CRYOABLATION FOR RADIORECURRENT PROSTATE CANCER: INITIAL EXPERIENCE AT A REGIONAL HEALTH CARE SYSTEM" BY SAFAVY. ET AL. 2019 IS A RETROSPECTIVE, SINGLE-CENTRE REVIEW OF 75 PATIENTS WHO RECEIVED CRYOABLATION TREATMENT FOR PROSTATE CANCER WITH EITHER GALIL (GALIL MEDICAL) OR ENDOCARE (ENDOCARE/HEALTHTRONICS INC). THE FOLLOWING COMPLICATIONS WERE REPORTED: 2 RECTAL FISTULAS, (2.7%), 5 URETHRAL STRICTURES (6.7%), 19 PATIENTS WITH STRESS URINARY INCONTINENCE REQUIRING AT LEAST 1 PAD PER DAY (25.3%), AND 1 DEATH CAUSED BY A PULMONARY EMBOLISM (1.3%). THE REPORTED DEATH EVENT WAS NOTED TO HAVE OCCURED PERIOPERATIVELY IN THE ARTICLE DISCUSSION. NO DEVICE MALFUNCTIONS WERE REPORTED IN THE ARTICLE. THE COMPLICATIONS DESCRIBED ARE NOT NOTED TO BE SERIOUS IN NATURE NOR HAVE REQUIRED INTERVENTION TO PREVENT SERIOUS INJURY. MEDICAL REVIEW NOTED THAT THE HARMS AND THEIR ASSOCIATED SEVERITY ARE COVERED UNDER THE EXISTING LABELLING FOR CRYOABLATION PRODUCTS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRO CODE: OCL. THIS COMPLAINT IS DERIVED FROM THE LITERATURE ARTICLE TITLED: "SAFAVY, S., JABAJI, R. B., LU, S. M., SLEZAK, J. M., COSMATOS, H. A., WILLIAMS, S. G., & FINLEY, D. S. (2019). SALVAGE CRYOABLATION FOR RADIO RECURRENT PROSTATE CANCER: INITIAL EXPERIENCE AT A REGIONAL HEALTH CARE SYSTEM. THE PERMANENTE JOURNAL." PERM J 2019;23:18 TO 153, HTTPS://DOI.ORG/10.7812/TPP/18-153. PUBLICATION DATE: JAN 2020 - DEFAULT TO FIRST DAY OF THE MONTH, 01 JAN 2020.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE THAT DURING A PROSTATE CRYOABLATION PROCEDURE, A PATIENT DIED FROM A PULMONARY EMBOLISM. THE PUBLISHED LITERATURE ARTICLE: "SALVAGE CRYOABLATION FOR RADIO RECURRENT PROSTATE CANCER: INITIAL EXPERIENCE AT A REGIONAL HEALTH CARE SYSTEM" BY SAFAVY. ET AL. 2019 IS A RETROSPECTIVE, SINGLE-CENTRE REVIEW OF 75 PATIENTS WHO RECEIVED CRYOABLATION TREATMENT FOR PROSTATE CANCER WITH EITHER GALIL (GALIL MEDICAL) OR ENDOCARE (ENDOCARE/HEALTHTRONICS INC). THE FOLLOWING COMPLICATIONS WERE REPORTED: 2 RECTAL FISTULAS, (2.7%), 5 URETHRAL STRICTURES (6.7%), 19 PATIENTS WITH STRESS URINARY INCONTINENCE REQUIRING AT LEAST 1 PAD PER DAY (25.3%), AND 1 DEATH CAUSED BY A PULMONARY EMBOLISM (1.3%). THE REPORTED DEATH EVENT WAS NOTED TO HAVE OCCURED PERIOPERATIVELY IN THE ARTICLE DISCUSSION. NO DEVICE MALFUNCTIONS WERE REPORTED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568869 UNIT, CRYOSURGICAL, ACCESSORIES GEH GALIL MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death