FDA Adverse Event
Death
Summary report: N
CELSIUS TERMOCOOL TC
MDR report key: 1698588
·
Received May 21, 2010
Report
- Report Number
- 2029046-2010-00023
- Event Type
- Death
- Date Received
- May 21, 2010
- Date of Event
- January 1, 2010
- Report Date
- April 23, 2010
- Manufacturer
- BIOSENSE WEBSTER, INC. (IRWINDALE)
- Product Code
- DRF
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CATHETER'S SPECIFIC MODEL # AND LOT # WERE: UNK. (B) (4)
Description of Event or Problem · 1
IT WAS REPORTED THAT APPROXIMATELY 3 MONTHS AFTER AN AF ABLATION PROCEDURE USING PRODUCTS FROM VARIOUS MFRS INCLUDING BIOSENSE WEBSTER, A PT DEVELOPED A PROGRESSIVE DEGENERATIVE CONDITION LATER DIAGNOSED AS DISSEMINATED INTRAVASCULAR COAGULOPATHY FROM WHICH THE PT THEN DIED FROM. FOLLOWING POST MORTEM, MICROSCOPIC FOREIGN BODIES WERE FOUND IN VARIOUS ORGANS DOWNSTREAM OF THE LEFT ATRIUM, AND IT WAS ASSUMED THAT THESE FOREIGN BODIES COULD ONLY HAVE COME FROM THE AF PROCEDURE. THESE MICROSCOPIC FOREIGN BODIES ARE BEING RECOVERED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CELSIUS TERMOCOOL TC | DRF CATHETER, ELECTRODE RECORDING | DRF | BIOSENSE WEBSTER, INC. (IRWINDALE) | CELSIUS THERMO TC | UNK_CELSIU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Death |