FDA Adverse Event
Injury
Summary report: N
BIOSENSE WEBSTER RMT CATHETER
MDR report key: 858265
·
Received June 1, 2007
Report
- Report Number
- 2029046-2007-00066
- Event Type
- Injury
- Date Received
- June 1, 2007
- Date of Event
- May 4, 2007
- Report Date
- June 1, 2007
- Manufacturer
- BIOSENSE WEBSTER, INC.
- Product Code
- DRF
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
THE SECTION ON PRECAUTIONS IN THE INSTRUCTION FOR USE STATES "CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION, OR TAMPONADE."
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING ABLATION, A PERFORATION WAS DISCOVERED WHEN THE PT'S BLOOD PRESSURE DROPPED FROM 100 TO 50. MEDICAL INTERVENTION ADMINISTERED WAS PERICARDIAL DRAIN. THE PROGNOSIS OF THE PT WAS REPORTED TO BE EXCELLENT. CATHETER USED DURING THE PROCEDURE WAS BIOSENSE WEBSTER RMT CATHETER. NO PRODUCT CATALOG NUMBER OR SERIAL NUMBER WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOSENSE WEBSTER RMT CATHETER | ELECTROPHYSIOLOGY CATHETER | DRF | BIOSENSE WEBSTER, INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI YR | Life Threatening |