FDA Adverse Event
Injury
Summary report: N
CARTO XP EP NAVIGATION SYSTEM
MDR report key: 2760076
·
Received June 1, 2007
Report
- Report Number
- 9681484-2007-00067
- Event Type
- Injury
- Date Received
- June 1, 2007
- Date of Event
- May 3, 2007
- Report Date
- May 30, 2007
- Manufacturer
- BIOSENSE WEBSTER (ISRAEL), LTD.
- Product Code
- DQK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
INITIALLY REPORTED THAT THE CARTO SYSTEM KEPT FREEZING AND TROUBLE IN LOCATING CATHETER DURING MAPPING. THEN PATIENT INJURY WAS REPORTED. PATIENT INJURY WAS REPORTED UPON COMPLETION OF ABLATION IN THE LEFT ATRIUM. THE PATIENT WAS UNSTABLE AND A LARGE PERICARDIAL EFFUSION ON THE IC ECHO WAS NOTED. PATIENT WAS TREATED WITH FLUID, VASOPRESSORS AND AN EMERGENCY PERICARDIOCENTESIS TO DRAIN 600 CC OF BLOOD FROM THE PERICARDIAL SACK. SHE HAD 3 ADDITIONAL DAYS OF HOSPITALIZATION AND IS DOING WELL AT HIS TIME. ISSUE WAS REPORTED SINCE OUR CATHETER WAS IN USE WHEN THE INCIDENT OCCURRED. INCIDENT APPEARED TO BE PHYSICIAN ERROR ACCORDING TO THE CUSTOMER OR PROCEDURE RELATED, RATHER THAN DEVICE RELATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARTO XP EP NAVIGATION SYSTEM | CARDIAC ELECTROPHYSIOLOGY MAPPING SYSTEM | DQK | BIOSENSE WEBSTER (ISRAEL), LTD. | CP-4055-00 | 4461 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization | TIP CATHETER| NAVISTAR DS DIAGNOSTIC/ABLATION DEFLECTABLE 8 MM |