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 2020-02-21 for FLEXABILITY? ABLATION CATHETER, SENSOR ENABLED? A-FASE-D manufactured by St. Jude Medical.
[180756250]
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
[180756251]
Following a ventricular tachycardia ablation procedure, a cardiac perforation occurred. The patient became hypotensive and a trans esophageal echocardiogram confirmed a 1cm pericardial effusion. A pericardiocentesis was performed, however the effusion did not terminate and the patient underwent cardiosurgery. The surgeon reported a likely perforation of the left ventricle, close to the apex, in the setting of a very thin and fragile myocardium. The surgical procedure successfully treated the perforation. The physician indicated the cause of the perforation was likely done when mapping the left ventricle with the flexibility se catheter. The patient was recovering in the icu and eventually transferred. There were no performance issues with the abbott device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005334138-2020-00062 |
| MDR Report Key | 9741851 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-21 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-02-07 |
| Date Mfgr Received | 2020-02-28 |
| Date Added to Maude | 2020-02-21 |
| 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 (AFD-PLYMOUTH) |
| 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 | FLEXABILITY? ABLATION CATHETER, SENSOR ENABLED? |
| Generic Name | CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER |
| Product Code | OAD |
| Date Received | 2020-02-21 |
| Model Number | A-FASE-D |
| 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. Other | 2020-02-21 |