MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-09-14 for NRG TRANSSEPTAL NEEDLE manufactured by Baylis Medical Company Inc..
[120291977]
There is no suspected device failure. The reported patient complication is an inherent risk to this type of procedure. There is no evidence to suggest that the baylis medical device caused or contributed to the reported incident. This report is being submitted as the baylis medical device was among the many devices used during the procedure.
Patient Sequence No: 1, Text Type: N, H10
[120291978]
The baylis medical nrg transseptal needle (rf needle) was used for transseptal puncture in a patient undergoing an atrial fibrillation procedure. Tenting and rf needle location were confirmed using intracardiac echocardiography (ice) and fluoroscopy. Rf energy was applied, but septum crossing was unsuccessful. Tenting and location were reconfirmed using imaging. Rf energy was applied, but crossing was still not successful. The device assembly (sheath, dilator, and rf needle) was removed from the patient and the transseptal procedure was started again. Transseptal puncture was attempted two more times unsuccessfully. A pericardial effusion was observed. The procedure was aborted and action was taken to remedy the issue. There is no evidence to suggest that the baylis medical device caused or contributed to the reported incident. This report is being submitted as the baylis medical device was among the many devices used during the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710452-2018-00035 |
| MDR Report Key | 7877017 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-09-14 |
| Date of Report | 2018-09-14 |
| Date of Event | 2018-08-15 |
| Date Mfgr Received | 2018-08-15 |
| Date Added to Maude | 2018-09-14 |
| 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 | 2018-09-14 |
| 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 | 2018-09-14 |