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 2020-01-20 for BRK? TRANSSEPTAL NEEDLE, 71 CM LENGTH 407200 manufactured by St. Jude Medical.
[176076728]
The results/method and conclusion codes along with investigation results will be provided in the final report. Further information regarding the event were requested but not received.
Patient Sequence No: 1, Text Type: N, H10
[176076729]
Related manufacturer reference: 3008452825-2020-00028, 3005334138-2020-00024. During a tricuspid valve ablation procedure, a pericardial effusion occurred. Following transeptal puncture, substrate mapping of the left ventricle was started with the ablation catheter and then with mapping catheter. After a few minutes, the patient became hypotensive. Echocardiogram confirmed a pericardial effusion for which a pericardiocentesis was performed to stabilize the patient. The cause and location of the effusion remains unknown. There were no performance issues with any abbott device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008452825-2020-00027 |
| MDR Report Key | 9606616 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-20 |
| Date of Report | 2020-02-17 |
| Date of Event | 2020-01-10 |
| Date Mfgr Received | 2020-01-21 |
| Device Manufacturer Date | 2019-08-09 |
| Date Added to Maude | 2020-01-20 |
| 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 (AFD) |
| 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 | BRK? TRANSSEPTAL NEEDLE, 71 CM LENGTH |
| Generic Name | TROCAR |
| Product Code | DRC |
| Date Received | 2020-01-20 |
| Model Number | 407200 |
| Catalog Number | 407200 |
| Lot Number | 7127930 |
| 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 | 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. Other | 2020-01-20 |