FDA Adverse Event
Malfunction
Summary report: N
SEEDNET GOLD CRYOABLATION SYSTEM
MDR report key: 17931789
·
Received October 13, 2023
Report
- Report Number
- 2124215-2023-56741
- Event Type
- Malfunction
- Date Received
- October 13, 2023
- Date of Event
- September 19, 2023
- Report Date
- October 13, 2023
- Manufacturer
- BTG YOKNEAM
- Product Code
- GEH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
D2B: PRODUCT CODE- GEH, OCL.
Description of Event or Problem · 0
IT WAS REPORTED THAT AN ADDITIONAL SURGERY WAS REQUIRED AFTER INSUFFICIENT ICE WAS OBSERVED. THREE ICEROD PLUS 90 DEGREE NEEDLES WERE USED IN A LIVER CRYOABLATION PROCEDURE. THE SPACING BETWEEN THE NEEDLES WAS 1.5 CM. DURING THE PROCEDURE, HOWEVER, IT WAS NOTICED THAT THERE WAS A DELAY IN THE ICE FORMATION, AND THE ICEBALL WAS SMALLER THAN WAS EXPECTED. DESPITE CHANGING THE NEEDLES TO OTHER CHANNELS AND OTHER TROUBLESHOOTING MEASURES, THE NEEDLES STILL DID NOT FREEZE. DUE TO THE INSUFFICIENT ICE COVERAGE, THE PROCEDURE WAS NOT ABLE TO BE COMPLETED, AND ANOTHER WAS SCHEDULED FOR A LATER DATE. THE REPEAT SURGERY RESOLVED THE INCIDENT, AND NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 704613 | SEEDNET GOLD CRYOABLATION SYSTEM | UNIT, CRYOSURGICAL, ACCESSORIES | GEH | BTG YOKNEAM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Male |