MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-01-22 for NRG TRANSSEPTAL NEEDLE NRG-E-HF-71-C0 manufactured by Baylis Medical Company Inc..
[175921974]
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
[175921975]
During a procedure in which the nrg transseptal needle was used, a cardiac tamponade occurred. Following the procedure, the patient expired. During an ablation procedure for atrial fibrillation, an nrg transseptal needle was used for transseptal puncture. A biosense webster ablation catheter was introduced to the heart before the rf needle. Ablation was performed inside the right atrium and then the rf needle was used to access the left atrium. During the procedure, after transseptal puncture had been completed, the patient's blood pressure decreased and the patient experienced difficulty breathing and bradycardia. The patient's blood pressure kept decreasing and the patient went into shock. The patient received intubation and subsequently underwent cardiac surgery. Cardiac tamponade was confirmed but the location of the perforation was unknown. The patient was hospitalized in a coronary care unit with the use of a percutaneous cardiopulmonary support system. Following the case on (b)(6) 2019, the patient expired on (b)(6) 2019. There is no evidence to suggest that a baylis medical device caused or contributed to the reported incident. However, as baylis medical device were 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 | 9710452-2020-00003 |
| MDR Report Key | 9617821 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-01-22 |
| Date of Report | 2020-01-22 |
| Date of Event | 2019-12-26 |
| Date Mfgr Received | 2019-12-26 |
| Date Added to Maude | 2020-01-22 |
| 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 | 2020-01-22 |
| Model Number | NRG-E-HF-71-C0 |
| Lot Number | NGFA180419 |
| 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. Death | 2020-01-22 |