FDA Adverse Event
Other
Summary report: N
VENASONIX
MDR report key: 390971
·
Received April 25, 2002
Report
- Report Number
- 2020638-2002-00005
- Event Type
- Other
- Date Received
- April 25, 2002
- Date of Event
- March 27, 2002
- Report Date
- March 27, 2002
- Manufacturer
- BIOSENSE WEBSTER, INC.
- Product Code
- ITX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
DURING AN "EP" PROCEDURE FOR ATRIAL FIBRILLATION USING A VENASONIX ULTRASOUND CATHETER PHRENIC NERVE PALSY OCCURRED. THIS IS A KNOWN SHORT TERM COMPLICATION. THE DOCTOR NOTICED THAT AT 60 SECONDS INTO THE VENASONIX ULTRASOUND, BURN OF THE RIGHT SUPERIOR PULMONARY VEIN, RIGHT DIAPHRAMATIC DAMAGE OCCURRED, HE IMMEDIATELY STOPPED. THE PROCEDURE WAS THEN COMPLETED BY "RF" APPLICATIONS. IN TOTAL 4 VENASONIX BURNS AND 14 "RF" BURNS COMPLETED THE PROCEDURE. 24 HOURS AFTER PROCEDURE THE DAMAGE WAS STILL PRESENT, BUT THE PATIENT WAS ASYMPTOMATIC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VENASONIX | CIRCUMFERENTIAL ULTRASOUND BALLOON CATHETER | ITX | BIOSENSE WEBSTER, INC. | D-1300-70-S | B12C0683B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Other | RF CATHETER 2002. |