MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-24 for TACTICATH? CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED? BID CURVE D-F A-TCSE-DF manufactured by St. Jude Medical, Costa Rica Ltda.
[184711120]
The results, method and conclusion codes along with investigation results will be provided in the final report.
Patient Sequence No: 1, Text Type: N, H10
[184711121]
During a pulmonary vein isolation ablation procedure, a pericardial effusion occurred. At the end of the procedure, as the ablation catheter was being manipulated in the left ventricle, the patient became hypotensive. X-ray determined that the heart was not moving normally and a pericardial effusion was identified. A pericardiocentesis was performed and approximately 500ml of blood was drained so the patient was then transferred to the operating room for surgical repair and stabilization. There were no performance issues with any abbott device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008452825-2020-00161 |
| MDR Report Key | 9871252 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-03-19 |
| Date Mfgr Received | 2020-03-19 |
| Device Manufacturer Date | 2019-12-04 |
| Date Added to Maude | 2020-03-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STEPHANIE O' SULLIVAN |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517565400 |
| Manufacturer G1 | ST. JUDE MEDICAL, COSTA RICA LTDA |
| Manufacturer Street | PARQUE INDUSTRIAL, ZONA FRANCA COYOL S.A. EDIFICIO #44B, CALLE 0, AVENIDA 2, COYOL |
| Manufacturer City | ALAJUELA, COSTA RICA 1897-4050 |
| Manufacturer Country | CS |
| Manufacturer Postal Code | 1897-4050 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TACTICATH? CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED? BID CURVE D-F |
| Generic Name | CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION |
| Product Code | OAE |
| Date Received | 2020-03-24 |
| Model Number | A-TCSE-DF |
| Catalog Number | A-TCSE-DF |
| Lot Number | 7298283 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, COSTA RICA LTDA |
| Manufacturer Address | PARQUE INDUSTRIAL, ZONA FRANCA COYOL S.A. EDIFICIO #44B, CALLE 0, AVENIDA 2, COYOL ALAJUELA, COSTA RICA 1897-4050 CS 1897-4050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-24 |