MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-03-26 for NRG TRANSSEPTAL NEEDLE NRG-E-HF-98-C1 manufactured by Baylis Medical Company Inc..
[139958230]
Review of the device history record for the lot in question confirmed that all parts met manufacturing requirements prior to release. There is no evidence to suggest that the baylis medical device caused or contributed to the reported incident. However, as the baylis device was reported to be among the devices used in the procedure, baylis medical has decided to submit this report. 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
[139958231]
The nrg transseptal needle (nrg needle) and torflex transseptal guiding sheath (tfk) were used for transseptal puncture in a procedure. The physician noticed an effusion on intracardiac echocardiography (ice) following the first and during the second transseptal puncture. The physician used an agilis sheath and 98 cm c1 nrg needle to perform the first transseptal puncture. The physician was able to puncture across the septum easily in a safe position in the middle of the septum via ice. The physician then prepared for the second transseptal using the 45 degree tfk and 71 cm c1 nrg needle. The physician had some difficulty getting into the correct position and was in a very posterior and low position with the sheath and dilator. The nrg needle was never exposed in this position. The physician then torqued the sheath and needle into a better tenting position and applied rf energy for 1 second (constant). Before putting anything across the septum other than the nrg needle, the physician scanned ice and noticed a large effusion developing. The physician monitored the effusion for a few minutes and decided in consultation with another physician that a pericardial tap was required. Once tapped, the physician noted that the blood was very dark and most likely from the right ventricle (rv). The physician noted it was very unlikely that the complication would have occurred as a result of transseptal puncture. It was the opinion of the physician that while putting the coronary sinus (cs) catheter in place, a small effusion may have been caused that grew much worse after heparinizing, as this was precisely when the effusion was noticed on ice. There is no evidence to suggest that the baylis medical device caused or contributed to the reported incident. However, as the baylis device was reported to be among the devices used in the procedure, baylis medical has decided to submit this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710452-2019-00008 |
| MDR Report Key | 8454004 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-03-26 |
| Date of Report | 2019-03-26 |
| Date of Event | 2019-02-25 |
| Date Mfgr Received | 2019-02-25 |
| Date Added to Maude | 2019-03-26 |
| 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 | 2019-03-26 |
| Returned To Mfg | 2019-03-05 |
| Model Number | NRG-E-HF-98-C1 |
| Lot Number | NGFG101218 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-03-26 |