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 2020-01-15 for BRK-1? XS TRANSSEPTAL NEEDLE, 71 CM LENGTH G407209 manufactured by St. Jude Medical.
[175022916]
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
[175022917]
Related manufacturer reference: 3008452825-2020-00015, 3005334138-2020-00019, 3008452825-2020-00016, 3008452825-2020-00018, 3008452825-2020-00019, 3005334138-2020-00020, 3005334138-2020-00021. During the mapping of a ventricular tachycardia ablation procedure, following mapping of the right and left ventricle, the patient experienced respiratory failure and pulseless electrical activity. An immediate cardiac massage was performed, without the restoration of natural heart contraction. There was no pericardial effusion visible with the intracardiac echo and the procedure was interrupted before the ablation. The patient expired. The cause of the respiratory failure and subsequent death is unknown. There were no performance issues with any abbott device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008452825-2020-00017 |
| MDR Report Key | 9590521 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-15 |
| Date of Report | 2020-02-17 |
| Date of Event | 2020-01-08 |
| Date Mfgr Received | 2020-01-21 |
| Device Manufacturer Date | 2019-09-20 |
| Date Added to Maude | 2020-01-15 |
| 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-1? XS TRANSSEPTAL NEEDLE, 71 CM LENGTH |
| Generic Name | TROCAR |
| Product Code | DRC |
| Date Received | 2020-01-15 |
| Model Number | G407209 |
| Catalog Number | G407209 |
| Lot Number | 7190953 |
| 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. Death | 2020-01-15 |