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 2020-02-18 for TRANSSEPTAL NEEDLE, BRK SERIES manufactured by St. Jude Medical.
[183004104]
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
[183004105]
Related manufacturer reference: 3005334138-2020-00052, 3008452825-2020-00087, 2030404-2020-00010, 3005334138-2020-00053. During an atrial fibrillation ablation procedure, a cardiac tamponade occurred. The patient became hypotensive and went into cardiac arrest. Cpr was performed and an ultrasound/fluoroscopy confirmed a cardiac tamponade in the left atrium. A pericardiocentesis was administered to stabilize the patient. It was unclear at which point during the procedure the perforation occurred but it was suggested by the physician that it could have occurred earlier in the procedure, when the patient felt unwell and gagged, potentially moving the catheters inside the heart. There were no performance issues with any abbott device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008452825-2020-00086 |
| MDR Report Key | 9719965 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-18 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-01-30 |
| Date Mfgr Received | 2020-02-19 |
| Date Added to Maude | 2020-02-18 |
| 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 | TRANSSEPTAL NEEDLE, BRK SERIES |
| Generic Name | TRANSSEPTAL NEEDLE |
| Product Code | DRC |
| Date Received | 2020-02-18 |
| 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 | 2020-02-18 |