ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿
Report
- Report Number
- 3005334138-2019-00527
- Event Type
- Injury
- Date Received
- September 20, 2019
- Date of Event
- July 16, 2019
- Report Date
- October 3, 2019
- Manufacturer
- ST. JUDE MEDICAL
- Product Code
- DRF
- UDI-DI
- 05415067028198
- PMA / PMN Number
- K172393
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED PERICARDIAL EFFUSION COULD NOT BE CONCLUSIVELY DETERMINED. PER THE IFU, CARDIAC PERFORATION IS A KNOWN RISK DURING THE USE OF THIS DEVICE.
THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.
A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT.
RELATED MANUFACTURING REFERENCE: 3005334138-2019-00528, 2030404-2019-00095, 2030404-2019-00096, 2030404-2019-00097. FOLLOWING AN ABLATION PROCEDURE A PERICARDIAL EFFUSION OCCURRED. TWO HOURS FOLLOWING THE PROCEDURE THE PATIENT EXPERIENCED SLIGHT DIZZINESS. ECHOCARDIOGRAPHY DIAGNOSED AN EFFUSION APPROXIMATELY 15 MM CIRCULAR IN THE FRONT OF THE RIGHT ATRIUM AND RIGHT VENTRICLE. A PERICARDIAL EFFUSION WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 894317 | ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿ | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | DRF | ST. JUDE MEDICAL | D-AVHD-DF16 | 6944467 | 05415067028198 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |