FDA Adverse Event
Injury
Summary report: N
LASSO 2515 NAV VARIABLE CATHETER
MDR report key: 1951666
·
Received January 6, 2011
Report
- Report Number
- 2029046-2011-00001
- Event Type
- Injury
- Date Received
- January 6, 2011
- Date of Event
- December 9, 2010
- Report Date
- December 9, 2010
- Manufacturer
- BIOSENSE WEBSTER, INC (IRWINDALE)
- Product Code
- DRF
- PMA / PMN Number
- K081258
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER STATED THAT NONE OF THE BIOSENSE WEBSTER EQUIPMENT WAS AT FAULT. THE CATHETERS INVOLVED IN THE EVENT WERE DISCARDED AT THE END OF THE PROCEDURE AND WERE NOT RETURNED FOR INVESTIGATION. (B)(4). CONCOMITANT BIOSENSE WEBSTER PRODUCTS USED DURING THE PROCEDURE: C3 WEBSTER QUADRAPOLAR WITH AUTO ID - FIXED: CATALOG NO.: F5QF005CT, LOT NO.: 15131987. EZ STEER THERMOCOOL SF NAV: CATALOG NO: BNI35DFH, LOT NO.: 15201056L.
Description of Event or Problem · 1
DURING THE EE OF CARTO3 V2 THE PATIENT HAD A TAMPONADE AT THE END OF THE PROCEDURE. THE PATIENT WAS STABLE AFTER THE TREATMENT AND WAS DISCHARGED FROM HOSPITAL THE SETTINGS ON THE GENERATOR WERE 2ML-MAPPING, 8ML-ABLATION 30W AND IF 35W 15ML FLOW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LASSO 2515 NAV VARIABLE CATHETER | ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE | DRF | BIOSENSE WEBSTER, INC (IRWINDALE) | D-1290-02-S | UNKNOWN_D-1290-02-S |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R |