MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-11-22 for NRG TRANSSEPTAL NEEDLE manufactured by Baylis Medical Company Inc..
[128190962]
There is no suspected device failure. The reported patient complication is an inherent risk in this type of procedure.
Patient Sequence No: 1, Text Type: N, H10
[128190963]
The nrg transseptal needle was used transseptal puncture during a procedure. The physician retracted the transseptal needle, sheath and dilator from the superior vena cava (svc) into the right atrium and onto the interatrial septum. Tenting was observed and the physician instructed the nurse to apply radiofrequency (rf). The nurse held down the rf application button and no rf was applied before the needle mechanically crossed into the left atrium. The nurse released the rf application button and the needle perforated the left atrial appendage. Heparin was reversed and pericardiocentesis was performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710452-2018-00042 |
| MDR Report Key | 8098876 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-11-22 |
| Date of Report | 2018-11-22 |
| Date of Event | 2018-10-26 |
| Date Mfgr Received | 2018-10-26 |
| Date Added to Maude | 2018-11-22 |
| 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. EAST |
| 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 | 2018-11-22 |
| 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. Required No Informationntervention | 2018-11-22 |