ICESEED NEEDLE
Report
- Report Number
- 2124215-2025-66901
- Event Type
- Death
- Date Received
- September 29, 2025
- Date of Event
- May 29, 2025
- Report Date
- November 3, 2025
- Manufacturer
- BTG YOKNEAM
- Product Code
- GEH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC AS THE ACCOUNT DID NOT HAVE THE AVAILABLE INFORMATION. BECAUSE THE PRODUCT LOT NUMBER IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) #.
DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC AS THE ACCOUNT DID NOT HAVE THE AVAILABLE INFORMATION. BECAUSE THE PRODUCT LOT NUMBER IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) #. H6 PATIENT CODES: CORRECTED E2328 OBSTRUCTION/OCCLUSION TO E2015 UNSPECIFIED TISSUE INJURY. H6 IMPACT CODES: ADDED F2303 MEDICATION REQUIRED.
IT WAS REPORTED THAT A PATIENT EXPIRED 6 WEEKS AFTER A CRYOABLATION PROCEDURE. ON (B)(6) 2025, THE PATIENT PRESENTED WITH AN ENDOPHYTIC RENAL TUMOR WITH A VESSEL-LIKE EXTENSION TOWARDS THE HILUM. THE TUMOR MEASURED 3.4 CENTIMETERS. ON (B)(6) 2025, A VISUAL ICE CRYOABLATION SYSTEM AND 3 ICEFORCE NEEDLES AND 1 ICEROD NEEDLE WERE USED TO TREAT THE TUMOR UNDER COMPUTED TOMAGRAPHY (CT) VISUALIZATION. THERE WERE NO MALFUNCTIONS DURING THE PROCEDURE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS DISCHARGED THE SAME DAY. ON (B)(6) 2025, THE PATIENT RETURNED WITH HEMATURIA AND THE INABILITY TO VOID/BLADDER RETENTION. A URINARY CATHETER WAS PLACED AND A MULTIPHASE CT SHOWED URINARY LEAK IN THE ABLATED AREA. ON (B)(6) 2025, AN ATTEMPT TO PUT A NEPHROSTOMY CATHETER WAS MADE, BUT HAD FAILED. LAB RESULTS DID NOT IMPROVE AS THE PATIENT REMAINED IN THE HOSPITAL, AND THE C-REACTIVE PROTEIN (CRP) LEVELS INCREASED. ON (B)(6) 2025, A J-J STENT WAS PLACED. HOWEVER, ON (B)(6) 2025, CRP LEVELS AGAIN INCREASED, AND A NEW CT SHOWED MORE FLUID (URINOMA) AND RETROPERITONEAL AIR AROUND THE ABLATED KIDNEY. ON (B)(6) 2025, STAPHYLOCOCCUS AUREUS WAS DETECTED IN BLOOD CULTURES INDICATING INFECTION. ON (B)(6) 2025, CT-GUIDED DRAIN WAS PLACED TO ONE OF THE FLUID COLLECTIONS. ON (B)(6) 2025, IT WAS PLANNED TO GET A CT-GUIDED NEPHROSTOMY DRAIN; HOWEVER, NOW THERE WAS NO VISIBLE LEAKAGE ON THE PRE-DRAIN CT AND NO HYDRONEPHROSIS. IT WAS DECIDED TO NOT PUT IN THE NP CATHETER, AS THE PATIENT ALREADY HAD THE J-J STENT. THE FOLLOWING DAYS, CRP AND LEUKOCYTE (LPK) LEVELS CONTINUED TO DECREASE. ON (B)(6) 2025, THE PATIENT WAS FEELING PRETTY GOOD. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT WAS CONFUSED, AND IN THE NIGHT, HE FELL AND HIT HIS HEAD AND CHEST. CT IMAGING SHOWED EXTRACRANIAL BLOOD, 2 DISLOCATED RIB FRACTURES, AND INCREASED URINOMAS. ON (B)(6) 2025, 2 CT-GUIDED DRAINAGES WERE PERFORMED (VENTRAL AND DORSOMEDIAL), AND A CT-GUIDED PLACEMENT OF AN NEPHROSTOMY (NP) CATHETER. FOLLOWING THE DRAINAGES, CRP/LPK LEVELS WERE SINKING. THE PATIENT IMPROVED SOME, AND THERE WERE NO BACTERIA IN DRAIN CULTURES BUT GROWTH OF CANDIDA. CONTINUED WITH IV ANTIBIOTICS AND ANTIFUNGAL TREATMENT. ON (B)(6) 2025, THE PATIENT FELT A LITTLE BETTER AND LAB VALUES WERE ALMOST NORMALIZED. THE PATIENT NOW ALSO RECEIVED TOTAL PARENTERAL NUTRITION (TPN) FOR EXTRA ENERGY AND NUTRITION TO HEAL. THE PATIENT, HOWEVER, WAS NOT WELL AND THE UROLOGIST DECIDED THAT THE SAFEST OPTION WAS TO PERFORM A NEPHRECTOMY. ON (B)(6) 2025, THE NEPHRECTOMY SURGERY WAS PERFORMED. IT WAS A DIFFICULT SURGERY BECAUSE OF HARD/FIBROTIC URINOMA INFLAMMATION. THERE WAS NO REMAINING TUMOR IN THE KIDNEY AND INFLAMMATION IN THE KIDNEY AND THE SURROUNDING TISSUES. ON (B)(6) 2025, THE PATIENT WAS TIRED AND UNSTABLE. THE PATIENT EXPERIENCED FAST ATRIAL FIBRILLATION, CARDIAC FAILURE AND INCREASED PLEURAL EFFUSION. A NEW CT OF THE HEAD, THORAX, AND ABDOMEN REVEALED THERE WAS STILL SOME FLUID COLLECTIONS IN THE POST-OPERATIVE AREA AND LEFT-SIDED PLEURAL EFFUSION. ON (B)(6) 2025, THE PATIENT WAS UNCOOPERATIVE WHEN GETTING A PLEURAL PIGTAIL; THEREFORE, NO DRAINAGE WAS INSERTED. A FEW DAYS LATER, AFTER SLOW WORSENING OF THE PATIENT CONDITION (WEAK/ATRIAL FIBRILLATION, LOW BLOOD PRESSURE), THE PATIENT EXPIRED ON (B)(6) 2025. POSTMORTEM, IT WAS NOTED THAT THERE WAS NO CLEAR CAUSE OF DEATH.
IT WAS REPORTED THAT A PATIENT EXPIRED 6 WEEKS AFTER A CRYOABLATION PROCEDURE. ON (B)(6) 2025, THE PATIENT PRESENTED WITH AN ENDOPHYTIC RENAL TUMOR WITH A VESSEL-LIKE EXTENSION TOWARDS THE HILUM. THE TUMOR MEASURED 3.4 CENTIMETERS. ON (B)(6) 2025, A VISUAL ICE CRYOABLATION SYSTEM AND 3 ICEFORCE NEEDLES AND 1 ICEROD NEEDLE WERE USED TO TREAT THE TUMOR UNDER COMPUTED TOMAGRAPHY (CT) VISUALIZATION. THERE WERE NO MALFUNCTIONS DURING THE PROCEDURE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS DISCHARGED THE SAME DAY. ON (B)(6) 2025, THE PATIENT RETURNED WITH HEMATURIA AND THE INABILITY TO VOID/BLADDER RETENTION. A URINARY CATHETER WAS PLACED AND A MULTIPHASE CT SHOWED URINARY LEAK IN THE ABLATED AREA. ON (B)(6) 2025, AN ATTEMPT TO PUT A NEPHROSTOMY CATHETER WAS MADE, BUT HAD FAILED. LAB RESULTS DID NOT IMPROVE AS THE PATIENT REMAINED IN THE HOSPITAL, AND THE C-REACTIVE PROTEIN (CRP) LEVELS INCREASED. ON (B)(6) 2025, A J-J STENT WAS PLACED. HOWEVER, ON (B)(6) 2025, CRP LEVELS AGAIN INCREASED, AND A NEW CT SHOWED MORE FLUID (URINOMA) AND RETROPERITONEAL AIR AROUND THE ABLATED KIDNEY. ON (B)(6) 2025, STAPHYLOCOCCUS AUREUS WAS DETECTED IN BLOOD CULTURES INDICATING INFECTION. ON (B)(6) 2025, CT-GUIDED DRAIN WAS PLACED TO ONE OF THE FLUID COLLECTIONS. ON (B)(6) 2025, IT WAS PLANNED TO GET A CT-GUIDED NEPHROSTOMY DRAIN; HOWEVER, NOW THERE WAS NO VISIBLE LEAKAGE ON THE PRE-DRAIN CT AND NO HYDRONEPHROSIS. IT WAS DECIDED TO NOT PUT IN THE NP CATHETER, AS THE PATIENT ALREADY HAD THE J-J STENT. THE FOLLOWING DAYS, CRP AND LEUKOCYTE (LPK) LEVELS CONTINUED TO DECREASE. ON (B)(6) 2025, THE PATIENT WAS FEELING PRETTY GOOD. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT WAS CONFUSED, AND IN THE NIGHT, HE FELL AND HIT HIS HEAD AND CHEST. CT IMAGING SHOWED EXTRACRANIAL BLOOD, 2 DISLOCATED RIB FRACTURES, AND INCREASED URINOMAS. ON (B)(6) 2025, 2 CT-GUIDED DRAINAGES WERE PERFORMED (VENTRAL AND DORSOMEDIAL), AND A CT-GUIDED PLACEMENT OF AN NEPHROSTOMY (NP) CATHETER. FOLLOWING THE DRAINAGES, CRP/LPK LEVELS WERE SINKING. THE PATIENT IMPROVED SOME, AND THERE WERE NO BACTERIA IN DRAIN CULTURES BUT GROWTH OF CANDIDA. CONTINUED WITH IV ANTIBIOTICS AND ANTIFUNGAL TREATMENT. ON (B)(6) 2025, THE PATIENT FELT A LITTLE BETTER AND LAB VALUES WERE ALMOST NORMALIZED. THE PATIENT NOW ALSO RECEIVED TOTAL PARENTERAL NUTRITION (TPN) FOR EXTRA ENERGY AND NUTRITION TO HEAL. THE PATIENT, HOWEVER, WAS NOT WELL AND THE UROLOGIST DECIDED THAT THE SAFEST OPTION WAS TO PERFORM A NEPHRECTOMY. ON (B)(6) 2025, THE NEPHRECTOMY SURGERY WAS PERFORMED. IT WAS A DIFFICULT SURGERY BECAUSE OF HARD/FIBROTIC URINOMA INFLAMMATION. THERE WAS NO REMAINING TUMOR IN THE KIDNEY AND INFLAMMATION IN THE KIDNEY AND THE SURROUNDING TISSUES. ON (B)(6) 2025, THE PATIENT WAS TIRED AND UNSTABLE. THE PATIENT EXPERIENCED FAST ATRIAL FIBRILLATION, CARDIAC FAILURE AND INCREASED PLEURAL EFFUSION. A NEW CT OF THE HEAD, THORAX, AND ABDOMEN REVEALED THERE WAS STILL SOME FLUID COLLECTIONS IN THE POST-OPERATIVE AREA AND LEFT-SIDED PLEURAL EFFUSION. ON (B)(6) 2025, THE PATIENT WAS UNCOOPERATIVE WHEN GETTING A PLEURAL PIGTAIL; THEREFORE, NO DRAINAGE WAS INSERTED. A FEW DAYS LATER, AFTER SLOW WORSENING OF THE PATIENT CONDITION (WEAK/ATRIAL FIBRILLATION, LOW BLOOD PRESSURE), THE PATIENT EXPIRED ON (B)(6) 2025. POSTMORTEM, IT WAS NOTED THAT THERE WAS NO CLEAR CAUSE OF DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1395809 | ICESEED NEEDLE | UNIT, CRYOSURGICAL, ACCESSORIES | GEH | BTG YOKNEAM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Male | Hospitalization| R| D |