ICESEED PROSTATE KIT / SE
Report
- Report Number
- 2134265-2021-06060
- Event Type
- Injury
- Date Received
- May 11, 2021
- Date of Event
- June 1, 2018
- Report Date
- June 14, 2021
- Manufacturer
- GALIL MEDICAL LTD
- Product Code
- GEH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
Narratives
IT WAS FURTHER IDENTIFIED THAT THIS ARTICLE WAS PREVIOUSLY REPORTED BY BSC; THIS EVENT IS BEING WITHDRAWN AS A DUPLICATE OF REPORT NUMBER 2134265-2020-18053. EXTERKATE, LEONIW, ET. AL., 'FUNCTIONAL AND ONCOLOGICAL OUTCOMES OF SALVAGE CRYOSURGERY FOR RADIORECURRENT PROSTATE CANCER', BJU INT 2020,DOIC:10.1111/BJU.15269. B2: DATE OF EVENT: THE TRUE EVENT DATE WAS NOT REPORTED. THE LITERATURE STATES THE PATIENTS WERE TREATED BETWEEN MAY 2006 AND JUNE 2018 AND WERE RETROSPECTIVELY ANALYZED.
IT WAS FURTHER IDENTIFIED THAT THIS ARTICLE WAS PREVIOUSLY REPORTED BY BSC; THIS EVENT IS BEING WITHDRAWN AS A DUPLICATE OF REPORT NUMBER 2134265-2020-18053. IT WAS REPORTED VIA LITERATURE THAT URINARY INCONTINENCE, IMPOTENCE, AND URINARY FISTULA OCCURRED. A TOTAL OF 169 CONSECUTIVE PATIENTS WERE RETROSPECTIVELY ANALYZED. ALL PATIENTS UNDERWENT SALVAGE CRYOSURGERY IN A SINGLE REFERRAL CENTRE BETWEEN 2006 AND 2018. THE PROCEDURES WERE PERFORMED BY A SINGLE SURGEON UNDER GENERAL/SPINAL ANAESTHESIA; 1.47 MM 17-G ICESEED (PROSTATE LENGTH <35 MM) OR ICEROD NEEDLES (PROSTATE LENGTH >35 MM; GALIL MEDICAL INC., ST PAUL, MN, USA) WERE TRANSPERINEALLY INSERTED IN THE PROSTATE UNDER TRUS-GUIDANCE. ON INDICATION, TWO CRYO NEEDLES WERE PLACED IN THE RECTAL WALL FOR ACTIVE WARMING. THERMOSENSORS WERE PLACED IN THE PROSTATE AND RECTAL WALL. AFTER EXCLUDING URETHRAL PERFORATION BY URETHROCYSTOSCOPY, A TRANSURETHRAL WARMING CATHETER WAS INSERTED. TWO CYCLES OF FREEZING WERE APPLIED USING ARGON/HELIUM GAS. REAL-TIME ASSESSMENT OF THE DIMENSION AND CONTOUR OF ICE BALLS WAS PERFORMED BY TRUS. EITHER WHOLE-GLAND OR HEMI-ABLATION WAS PERFORMED BASED ON TUMOUR EXTENSION. A SUPRAPUBIC CATHETER (INCIDENTALLY A TRANSURETHRAL CATHETER) WAS LEFT IN SITU FOR 7-14 DAYS. PATIENTS WERE DISCHARGED THE NEXT DAY. CIPROFLOXACIN, TAMSULOSIN AND MACROGOL WERE PRESCRIBED FOR 2, 4-6, AND 6 WEEKS, RESPECTIVELY. 20 PATIENTS REQUIRED DE-OBSTRUCTION BECAUSE OF URETHRAL SLOUGHING AND/OR STENOSIS WITHIN 12 MONTHS AFTER SALVAGE CRYOSURGERY (SCS), OF WHOM 17 PATIENTS UNDERWENT A TURP AND THREE PATIENTS A URETHROTOMY. 29 PATIENTS HAD NEW ONSET URINARY INCONTINENCE (UI), 10 OF WHOM NEEDED 2-3 PADS/24 H AND 19 NEEDED >3 PADS/24 H. THE CUMULATIVE INCIDENCE OF UI DECREASED OVER TIME. 57 PATIENTS HAD NEW-ONSET ERECTILE DYSFUNCTION (ED), OF WHOM 53 HAD COMPLETE LOSS OF ERECTILE FUNCTION WITH FOUR PATIENTS REPORTING IMPROVED ERECTILE FUNCTION WITH EITHER PAPAVERINE/PHENTOLAMINE INJECTIONS OR A PHOSPHODIESTERASE TYPE 5 INHIBITOR.11 PATIENTS WITH A PERSISTENT URINARY FISTULA, TWO UNDERWENT A COLOSTOMY AND GOT NEPHROSTOMY CATHETERS, TWO GOT A SUPRAPUBIC CATHETER AS A FINAL SOLUTION, FIVE UNDERWENT A CYSTOPROSTATECTOMY WITH A BRICKER CONDUIT, AND TWO UNDERWENT A GRACILIS-PLASTY TO CORRECT THE FISTULA.
EXTERKATE, LEONIW, ET. AL., 'FUNCTIONAL AND ONCOLOGICAL OUTCOMES OF SALVAGE CRYOSURGERY FOR RADIORECURRENT PROSTATE CANCER', BJU INT 2020,DOIC:10.1111/BJU.15269. DATE OF EVENT: THE TRUE EVENT DATE WAS NOT REPORTED. THE LITERATURE STATES THE PATIENTS WERE TREATED BETWEEN MAY 2006 AND JUNE 2018 AND WERE RETROSPECTIVELY ANALYZED.
IT WAS REPORTED VIA LITERATURE THAT URINARY INCONTINENCE, IMPOTENCE, AND URINARY FISTULA OCCURRED. A TOTAL OF 169 CONSECUTIVE PATIENTS WERE RETROSPECTIVELY ANALYZED. ALL PATIENTS UNDERWENT SALVAGE CRYOSURGERY IN A SINGLE REFERRAL CENTRE BETWEEN 2006 AND 2018. THE PROCEDURES WERE PERFORMED BY A SINGLE SURGEON UNDER GENERAL/SPINAL ANAESTHESIA; 1.47 MM 17-G ICESEED (PROSTATE LENGTH <35 MM) OR ICEROD NEEDLES (PROSTATE LENGTH >35 MM; GALIL MEDICAL INC., ST PAUL, MN, USA) WERE TRANSPERINEALLY INSERTED IN THE PROSTATE UNDER TRUS-GUIDANCE. ON INDICATION, TWO CRYO NEEDLES WERE PLACED IN THE RECTAL WALL FOR ACTIVE WARMING. THERMOSENSORS WERE PLACED IN THE PROSTATE AND RECTAL WALL. AFTER EXCLUDING URETHRAL PERFORATION BY URETHROCYSTOSCOPY, A TRANSURETHRAL WARMING CATHETER WAS INSERTED. TWO CYCLES OF FREEZING WERE APPLIED USING ARGON/HELIUM GAS. REAL-TIME ASSESSMENT OF THE DIMENSION AND CONTOUR OF ICE BALLS WAS PERFORMED BY TRUS. EITHER WHOLE-GLAND OR HEMI-ABLATION WAS PERFORMED BASED ON TUMOUR EXTENSION. A SUPRAPUBIC CATHETER (INCIDENTALLY A TRANSURETHRAL CATHETER) WAS LEFT IN SITU FOR 7-14 DAYS. PATIENTS WERE DISCHARGED THE NEXT DAY. CIPROFLOXACIN, TAMSULOSIN AND MACROGOL WERE PRESCRIBED FOR 2, 4-6, AND 6 WEEKS, RESPECTIVELY. 20 PATIENTS REQUIRED DE-OBSTRUCTION BECAUSE OF URETHRAL SLOUGHING AND/OR STENOSIS WITHIN 12 MONTHS AFTER SALVAGE CRYOSURGERY (SCS), OF WHOM 17 PATIENTS UNDERWENT A TURP AND THREE PATIENTS A URETHROTOMY. 29 PATIENTS HAD NEW ONSET URINARY INCONTINENCE (UI), 10 OF WHOM NEEDED 2-3 PADS/24 H AND 19 NEEDED >3 PADS/24 H. THE CUMULATIVE INCIDENCE OF UI DECREASED OVER TIME. 57 PATIENTS HAD NEW-ONSET ERECTILE DYSFUNCTION (ED), OF WHOM 53 HAD COMPLETE LOSS OF ERECTILE FUNCTION WITH FOUR PATIENTS REPORTING IMPROVED ERECTILE FUNCTION WITH EITHER PAPAVERINE/PHENTOLAMINE INJECTIONS OR A PHOSPHODIESTERASE TYPE 5 INHIBITOR.11 PATIENTS WITH A PERSISTENT URINARY FISTULA, TWO UNDERWENT A COLOSTOMY AND GOT NEPHROSTOMY CATHETERS, TWO GOT A SUPRAPUBIC CATHETER AS A FINAL SOLUTION, FIVE UNDERWENT A CYSTOPROSTATECTOMY WITH A BRICKER CONDUIT, AND TWO UNDERWENT A GRACILIS-PLASTY TO CORRECT THE FISTULA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 700510 | ICESEED PROSTATE KIT / SE | UNIT, CRYOSURGICAL, ACCESSORIES | GEH | GALIL MEDICAL LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |