ICESEED NEEDLE
Report
- Report Number
- 2124215-2025-57159
- Event Type
- Injury
- Date Received
- August 28, 2025
- Date of Event
- August 5, 2024
- Report Date
- May 8, 2026
- Manufacturer
- BTG YOKNEAM
- Product Code
- GEH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
B3: DATE OF EVENT ESTIMATED USING DATE ARTICLE WAS PUBLISHED. D3: MANUFACTURER ADDRESS 1: (B)(6). E1: INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. ZELLNER M, KELLENBERGER C, PISTORIUS S, DREHER T, PFAMMATTER T, KNUSEL P, GNANNT R. TECHNICAL FEASIBILITY AND OUTCOME OF CRYOABLATION OF ANEURYSMAL BONE CYSTS IN PEDIATRIC PATIENTS. FROM THE DEPARTMENT OF DIAGNOSTIC IMAGING (M.Z., C.J.K., S.P., R.G.), UNIVERSITY CHILDREN'S HOSPITAL ZURICH, ZURICH, SWITZERLAND; UNIVERSITY CHILDREN'S HOSPITAL ZURICH (M.Z., C.J.K., R.G.), CHILDREN'S RESEARCH CENTRE, ZURICH, SWITZERLAND; UNIVERSITY CHILDREN'S HOSPITAL ZURICH (T.D.), PEDIATRIC ORTHOPEDICS AND TRAUMATOLOGY, ZURICH, SWITZERLAND; UNIVERSITY HOSPITAL ZURICH (T.P.), INSTITUTE OF DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY, ZURICH, SWITZERLAND; AND CANTONAL HOSPITAL GRAUBUNDEN (P.K.), INSTITUTE OF DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY, CHUR, SWITZERLAND. RECEIVED APRIL 27, 2024; FINAL REVISION RECEIVED JULY 14, 2024; ACCEPTED JULY 27, 2024. DETAILED EVENT AND PRODUCT INFORMATION WAS NOT PROVIDED TO BOSTON SCIENTIFIC AS THIS WAS REPORTED THROUGH A LITERATURE ARTICLE. THE AUTHOR HAS BEEN CONTACTED IN ATTEMPT TO OBTAIN ADDITIONAL DETAILS.
CORRECTION: H6: PATIENT CODES: OBSTRUCTION/OCCLUSION CODE ADDED, AND NERVE DAMAGE AND TISSUE INJURY REMOVED. B3: DATE OF EVENT ESTIMATED USING DATE ARTICLE WAS PUBLISHED. D3: MANUFACTURER ADDRESS 1: TAVOR BUILDING 1, INDUSTRIAL PARK. E1: INITIAL REPORTER FACILITY NAME: (B)(6). ZELLNER M, KELLENBERGER C, PISTORIUS S, DREHER T, PFAMMATTER T, KNUSEL P, GNANNT R. TECHNICAL FEASIBILITY AND OUTCOME OF CRYOABLATION OF ANEURYSMAL BONE CYSTS IN PEDIATRIC PATIENTS. FROM THE DEPARTMENT OF DIAGNOSTIC IMAGING (M.Z., C.J.K., S.P., R.G.), UNIVERSITY CHILDREN'S HOSPITAL ZURICH, ZURICH, SWITZERLAND; UNIVERSITY CHILDREN'S HOSPITAL ZURICH (M.Z., C.J.K., R.G.), CHILDREN'S RESEARCH CENTRE, ZURICH, SWITZERLAND; UNIVERSITY CHILDREN'S HOSPITAL ZURICH (T.D.), PEDIATRIC ORTHOPEDICS AND TRAUMATOLOGY, ZURICH, SWITZERLAND; UNIVERSITY HOSPITAL ZURICH (T.P.), INSTITUTE OF DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY, ZURICH, SWITZERLAND; AND CANTONAL HOSPITAL GRAUBUNDEN (P.K.), INSTITUTE OF DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY, CHUR, SWITZERLAND. RECEIVED APRIL 27, 2024; FINAL REVISION RECEIVED JULY 14, 2024; ACCEPTED JULY 27, 2024. DETAILED EVENT AND PRODUCT INFORMATION WAS NOT PROVIDED TO BOSTON SCIENTIFIC AS THIS WAS REPORTED THROUGH A LITERATURE ARTICLE. THE AUTHOR HAS BEEN CONTACTED IN ATTEMPT TO OBTAIN ADDITIONAL DETAILS.
IT WAS REPORTED VIA LITERATURE ARTICLE THAT IN A RETROSPECTIVE STUDY, PATIENTS UNDERWENT AT LEAST ONE CRYOABLATION TO TREAT AN ANEURYSMAL BONE CYST (ABC). THE RETROSPECTIVE STUDY INCLUDED SEVEN CHILDREN WITH AN AGE RANGE FROM 3.0 TO 11.9 YEARS. IMAGING FOLLOW-UP AND CLINICAL EXAMINATION WERE PERFORMED BY RADIOGRAPHY AT 1 MONTH AND 6 MONTHS AFTER THE PROCEDURE. MAGNETIC RESONANCE (MR) IMAGING WAS TAKEN 3 MONTHS AND 12 MONTHS POST-OPERATIVELY. ADDITIONAL FOLLOW-UP AND IMAGING WERE CONDUCTED ON AN INDIVIDUAL BASIS. THE CRYOABLATION NEEDLES USED IN THE PROCEDURES INCLUDED BOSTON SCIENTIFIC'S ICESEED, ICESPHERE, ICEROD, AND ICEPEARL CX 2.1 NEEDLES. ONE PATIENT UNDERWENT 3 CRYOABLATION PROCEDURES, WITH 3 NEEDLES IN THE FIRST PROCEDURE, 1 NEEDLE IN THE SECOND PROCEDURE, AND 1 NEEDLE IN THE THIRD PROCEDURE. THE PATIENT DEMONSTRATED PREMATURE FUSION OF THE LEFT PROXIMAL FEMORAL EPIPHYSIS FOLLOWING CRYOABLATION, WHICH REQUIRED FOLLOW-UP SURGERY. THIS WAS FOLLOWED BY THE DEVELOPMENT OF A COXA MAGNA DEFORMITY. ANOTHER PATIENT UNDERWENT 3 CRYOABLATION PROCEDURES, WITH 8 NEEDLES IN THE FIRST PROCEDURE, 2 NEEDLES IN THE SECOND PROCEDURE, AND 1 NEEDLE IN THE THIRD PROCEDURE. THE PATIENT EXPERIENCED A PARALYTIC ILEUS AFTER THE INITIAL CRYOABLATION PROCEDURE, WHICH RESOLVED SPONTANEOUSLY. THIS WAS ATTRIBUTED TO THE PROXIMITY OF THE CRYOABLATION NEEDLES/FORMED ICE BALLS TO THE RECTOSIGMOID COLON. A THIRD PATIENT UNDERWENT A SINGLE CRYOABLATION PROCEDURE WITH 1 NEEDLE USED. THE PATIENT EXPERIENCED A PATHOLOGICAL FRACTURE AFTER CRYOABLATION PROCEDURE, WHICH WAS PAINLESS AND MANAGED WITH A CAST.
IT WAS REPORTED VIA LITERATURE ARTICLE THAT IN A RETROSPECTIVE STUDY, PATIENTS UNDERWENT AT LEAST ONE CRYOABLATION TO TREAT AN ANEURYSMAL BONE CYST (ABC). THE RETROSPECTIVE STUDY INCLUDED SEVEN CHILDREN WITH AN AGE RANGE FROM 3.0 TO 11.9 YEARS. IMAGING FOLLOW-UP AND CLINICAL EXAMINATION WERE PERFORMED BY RADIOGRAPHY AT 1 MONTH AND 6 MONTHS AFTER THE PROCEDURE. MAGNETIC RESONANCE (MR) IMAGING WAS TAKEN 3 MONTHS AND 12 MONTHS POST-OPERATIVELY. ADDITIONAL FOLLOW-UP AND IMAGING WERE CONDUCTED ON AN INDIVIDUAL BASIS. THE CRYOABLATION NEEDLES USED IN THE PROCEDURES INCLUDED BOSTON SCIENTIFIC'S ICESEED, ICESPHERE, ICEROD, AND ICEPEARL CX 2.1 NEEDLES. ONE PATIENT UNDERWENT 3 CRYOABLATION PROCEDURES, WITH 3 NEEDLES IN THE FIRST PROCEDURE, 1 NEEDLE IN THE SECOND PROCEDURE, AND 1 NEEDLE IN THE THIRD PROCEDURE. THE PATIENT DEMONSTRATED PREMATURE FUSION OF THE LEFT PROXIMAL FEMORAL EPIPHYSIS FOLLOWING CRYOABLATION, WHICH REQUIRED FOLLOW-UP SURGERY. THIS WAS FOLLOWED BY THE DEVELOPMENT OF A COXA MAGNA DEFORMITY. ANOTHER PATIENT UNDERWENT 3 CRYOABLATION PROCEDURES, WITH 8 NEEDLES IN THE FIRST PROCEDURE, 2 NEEDLES IN THE SECOND PROCEDURE, AND 1 NEEDLE IN THE THIRD PROCEDURE. THE PATIENT EXPERIENCED A PARALYTIC ILEUS AFTER THE INITIAL CRYOABLATION PROCEDURE, WHICH RESOLVED SPONTANEOUSLY. THIS WAS ATTRIBUTED TO THE PROXIMITY OF THE CRYOABLATION NEEDLES/FORMED ICE BALLS TO THE RECTOSIGMOID COLON. A THIRD PATIENT UNDERWENT A SINGLE CRYOABLATION PROCEDURE WITH 1 NEEDLE USED. THE PATIENT EXPERIENCED A PATHOLOGICAL FRACTURE AFTER CRYOABLATION PROCEDURE, WHICH WAS PAINLESS AND MANAGED WITH A CAST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 603097 | ICESEED NEEDLE | UNIT, CRYOSURGICAL, ACCESSORIES | GEH | BTG YOKNEAM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |