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 2020-03-11 for TACTICATH? CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED? BID CURVE D-F A-TCSE-DF manufactured by St. Jude Medical (afd-plymouth).
[183179061]
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
[183179062]
Six hours following an atrial fibrillation procedure, a cardiac tamponade occurred. Transthoracic echocardiogram diagnosed the tamponade. A pericardiocentesis was performed to stabilize the patient. There were no patient symptoms observed prior to the tamponade. During the procedure, force measurements increased up to 100 g when maneuvering the ablation catheter and the physician alleged the tamponade was due to the ablation catheter. There were no performance issues with any abbott device.
Patient Sequence No: 1, Text Type: D, B5
[188855623]
An event of a cardiac tamponade was reported. The results of the investigation are inconclusive since the device was not returned for analysis. In addition, no log files were received and a review of the device history record was not possible as not lot number was provided. Based on the information received, the cause of the reported cardiac tamponade could not be conclusively determined. Per the ifu, cardiac perforation is a known risk during the use of this device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005334138-2020-00093 |
| MDR Report Key | 9820858 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-03-23 |
| Date Added to Maude | 2020-03-11 |
| 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 | 2020-03-11 |
| 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 (AFD-PLYMOUTH) |
| Manufacturer Address | 5050 NATHAN LANE NORTH PLYMOUTH MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-11 |