FDA Adverse Event
Injury
Summary report: N
QUAD ALAZER II
MDR report key: 638786
·
Received September 30, 2005
Report
- Report Number
- 2939222-2005-00022
- Event Type
- Injury
- Date Received
- September 30, 2005
- Date of Event
- September 21, 2005
- Report Date
- September 30, 2005
- Manufacturer
- EP TECHNOLOGIES BSC .
- Product Code
- LPB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
DURING THE ABLATION A STEAM POP WAS HEARD. ABLATION WAS STOPPED AND THE CATHETER WAS PULLED OUT AND THE PATIENT CRASHED. (CODED) PATIENT WENT INTO SURGERY AND IS NOW DOING BETTER. "MACHINE SETTINGS WERE 50 WATTS.. 60 DEGREE'S 120 SECONDS LAST SETTINGS ON THE GENERATOR WHEN THE ABLATION WAS STOPPED AND IMPEDANCE WAS 93 AND THAT THE FIRST BURN." IN ADDITION THE ESI ARRAY CATHETER WAS ALSO BEING USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | QUAD ALAZER II | THERAPEUTIC CATHETERS | LPB | EP TECHNOLOGIES BSC . | M004 5086TH 0 | 6468060 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Life Threatening |