FDA Adverse Event
Injury
Summary report: N
FREEZOR MAX SURGICAL CRYOABLATION DEVICE
MDR report key: 703504
·
Received April 24, 2006
Report
- Report Number
- 3002648230-2006-00002
- Event Type
- Injury
- Date Received
- April 24, 2006
- Date of Event
- March 15, 2006
- Report Date
- April 3, 2006
- Manufacturer
- CRYOCATH TECHNOLOGIES, INC.
- Product Code
- NFC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PATIENT HAD FAILED PREVIOUS RF ABLATION. THE PHYSICIAN FIRST USED THE ENSITE ARRAY CATHETER TO DETERMINE THE PROXIMITY OF ABLATION TO THE PHRENIC NERVE, THEN THE PRESZOR MAX DEVICE. THE CRYOABLATIONS WERE CONDUCTED NEAR THE PHRENIC NERVE, PRIOR TO WHICH THE PHRENIC NERVE PACING WAS PERFORMED. THE THIRD ABLATION WAS LOCATED ON THE PHRENIC NERVE WHICH WAS MONITORED UNDER FLURO EVERY 30-40 SECONDS. THE PROCEDURE WAS HALTED WHEN THE PHYSICIAN SAW NO MOVEMENT OF THE PHRENIC NERVE. THE PATIENT SUFFERED FROM PHRENIC NERVE PARALYSIS AND WAS SCHEDULED TO RETURN TO THE HOSPITAL FOR FOLLOW UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FREEZOR MAX SURGICAL CRYOABLATION DEVICE | CARDIOVASCULAR CRYOCATHETER | NFC | CRYOCATH TECHNOLOGIES, INC. | 229F3 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |