FDA Adverse Event
Injury
Summary report: N
WEBSTER QUADROPOLAR - FIXED
MDR report key: 2629526
·
Received June 26, 2012
Report
- Report Number
- 2029046-2012-00087
- Event Type
- Injury
- Date Received
- June 26, 2012
- Date of Event
- June 1, 2012
- Report Date
- June 6, 2012
- Manufacturer
- BIOSENSE WEBSTER, INC (IRWINDALE)
- Product Code
- DRF
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT BWI PRODUCT USED DURING THE PROCEDURE: SMART TOUCH UNIDIRECTIONAL (DEVICE NOT MARKETED IN USA); MODEL #: D-1336-01-S, LOT #: 15530361M. PMA/510(K) #: K892265. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING MAPPING IN A PROCEDURE FOR AN ECTOPIC FOCUS IN THE LEFT VENTRICLE, THE PATIENT COMPLAINED OF CHEST PAIN. ECHOSCOPY WAS PERFORMED AND PERICARDIAL EFFUSION OF APPROXIMATELY 1.5CM IN SIZE WAS NOTED. THE PATIENT WAS TRANSFERRED TO THE CCU AND THE PROCEDURE STOPPED. A PERICARDIAL PUNCTURE WAS DONE. NO OTHER INFORMATION IS AVAILABLE AT THIS POINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WEBSTER QUADROPOLAR - FIXED | CATHETER, ELECTRODE RECORDING | DRF | BIOSENSE WEBSTER, INC (IRWINDALE) | WEBSTER QUADROPOLAR - FIXED | UNK_WBSTRQDRPLR-FXD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R |