MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-09-11 for NRG TRANSSEPTAL NEEDLE NRG-E-HF-98-C1 manufactured by Baylis Medical Company Inc..
[119928829]
There is no suspected device failure. The reported patient complication is an inherent risk to this type of procedure.
Patient Sequence No: 1, Text Type: N, H10
[119928830]
The baylis medical nrg transseptal needle (rf needle) was used for transseptal puncture in a patient undergoing an atrial fibrillation procedure for the second time. The patient was anesthetized and access was obtained via the right and left groin. An intracardiac echocardiography (ice) catheter was inserted into the left groin. The rf needle was inserted through a sheath to the superior vena cava and dropped onto the fossa. Tenting was observed on ice and rf energy was applied to cross the septum. Pressure monitoring and oxygen saturation levels were obtained to confirm access to the left atrium. The rf needle and dilator were retracted back to the right atrium. A second successful puncture was obtained to the left atrium with the rf needle. The patient experienced a brief drop in blood pressure and re-stabilized. Once in the left atrium, mapping was performed and an ablation was performed. A pericardial effusion was observed on ice and continued to increase during the ablation. The procedure was cancelled and heparin was reversed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710452-2018-00034 |
| MDR Report Key | 7866577 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-09-11 |
| Date of Report | 2018-08-13 |
| Date of Event | 2018-08-13 |
| Date Mfgr Received | 2018-08-13 |
| Date Added to Maude | 2018-09-11 |
| 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 | DR. MEGHAL KHAKHAR |
| Manufacturer Street | 2775 MATHESON BLVD. EEAST |
| Manufacturer City | MISSISSAUGA, ONTARIO L4W 4P7 |
| Manufacturer Country | CA |
| Manufacturer Postal | L4W 4P7 |
| Manufacturer G1 | BAYLIS MEDICAL COMPANY INC. |
| Manufacturer Street | 2775 MATHESON BLVD. EAST |
| Manufacturer City | MISSISSAUGA, ONTARIO L4W 4P7 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | L4W 4P7 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NRG TRANSSEPTAL NEEDLE |
| Generic Name | RF TRANSSEPTAL NEEDLE |
| Product Code | DXF |
| Date Received | 2018-09-11 |
| Model Number | NRG-E-HF-98-C1 |
| Catalog Number | NRG-E-HF-98-C1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAYLIS MEDICAL COMPANY INC. |
| Manufacturer Address | 5959 TRANS-CANADA HIGHWAY MONTREAL, QUEBEC H4T 1A1 CA H4T 1A1 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-11 |