FDA Adverse Event
Injury
Summary report: N
EZ STEER THERMOCOOL NAV BI-DIRECTIONAL CATHETER
MDR report key: 1746903
·
Received July 6, 2010
Report
- Report Number
- 2029046-2010-00030
- Event Type
- Injury
- Date Received
- July 6, 2010
- Date of Event
- May 20, 2010
- Report Date
- June 8, 2010
- Manufacturer
- BIOSENSE WEBSTER, INC (IRWINDALE)
- Product Code
- OAD
- PMA / PMN Number
- P030031
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CONCOMITANT BIOSENSE WEBSTER PRODUCTS USED DURING THE PROCEDURE: GENERIC - WEBSTER DECAPOLAR - DEFLECTABLE: CATALOG NO: UNKNOWN, LOT NO: UNKNOWN. STOCKERT 70 SYSTEM: MODEL NO: M-5463-01, (B)(4). CARTO 3 SYSTEM: MODEL NO: M-4800-01, (B)(4). COOL FLOW PUMP, U.S. SHIP KIT: MODEL NO: M-5491-02, (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT IN PASSING CONVERSATION AFTER A SUCCESSFUL AF CASE SEVERAL WEEKS AGO, THE PATIENT WAS SENT TO HOLDING WHEN 20 MINUTES LATER, IT WAS NOTICED THAT THE PATIENT'S BLOOD PRESSURE HAD DROPPED. A SURFACE ECHO CONFIRMED PERICARDIAL EFFUSION/TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS HELD FOR OBSERVATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EZ STEER THERMOCOOL NAV BI-DIRECTIONAL CATHETER | CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER | OAD | BIOSENSE WEBSTER, INC (IRWINDALE) | D-1292-05-S | UNKNOWN_D-1292-05-S |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R |