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 2020-03-17 for TACTICATH? CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED? BID CURVE D-F A-TCSE-DF manufactured by St. Jude Medical.
[183736097]
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.?
Patient Sequence No: 1, Text Type: N, H10
[183736098]
During an idiopathic ventricular tachycardia procedure, a cardiac tamponade occurred. While ablating in the left ventricle, the patient experienced chest pain. Ablation was stopped and the patient's blood pressure began to decrease. Fluoroscopy confirmed the left side of the heart was not moving properly. Ultrasound identified a cardiac tamponade near the apex where multiple ablations were performed. A pericardial drain was used to stabilize the patient. There were no performance issues with any abbott device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005334138-2020-00113 |
| MDR Report Key | 9841508 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-23 |
| Date Added to Maude | 2020-03-17 |
| 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 |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55442 |
| 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 | 2020-03-17 |
| Model Number | A-TCSE-DF |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL |
| Manufacturer Address | 5050 NATHAN LANE NORTH PLYMOUTH MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-17 |