MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-03-21 for NRG TRANSSEPTAL NEEDLE NRG-E-HF-71-C1 manufactured by Baylis Medical Company Inc..
[139548761]
It was determined that the lot number of the nrg transseptal needle used in the procedure was either ngfg040618 or ngfg060718, the expiry date was either 28-may-2021 or 28-jun-2021 and the unique device identifier (udi) was either (b)(4) or (b)(4). 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: N, H10
[139548762]
A report was received indicating that an embolic event occurred in a patient following an atrial fibrillation procedure. This report is being submitted because in which the nrg transseptal needle (rf needle) was of the several devices used in the procedure. During the procedure, two swartz braided transseptal guiding introducers were inserted through the right femoral vein along with a sheath from another manufacturer and an electrophysiology (ep) catheter. Double transseptal puncture was achieved with the rf needle and the two swartz introducers were advanced to the left atrium. Through one of the swartz sheaths, an inquiry ep catheter was used for pre-ablation mapping on each of the four pulmonary veins and then placed in the left superior pulmonary vein. A tacticath se irrigated ablation catheter was inserted through the second swartz sheath and used to ablate all four pulmonary veins and then the left atrial (la) roof and bottom lines to isolate the posterior wall. There was an impedance increase during the ablation procedure. The tacticath se catheter was removed from the patient for inspection. No anomalies were observed so the catheter was re-inserted and the procedure resumed. The procedure was completed with no adverse patient consequences. Following the procedure, the patient experienced decreased visual acuity and difficulty speaking. Symptoms of an embolic event were observed so the patient was transferred to another hospital. During transfer, the patient became paralyzed on the left side of the body. Magnetic resonance imaging (mri) and computed tomography (ct) scans were performed and revealed a substance within the brain, similar in intensity to bone. A thrombolytic agent was administered but did not dissolve the substance. A catheter was used to try and remove the substance with no resolution. The patient still has paralysis in their left leg but is able to speak. Other than the increased impedance, there were no abnormal observations and no failure had been observed with any of the devices used. The patient was receiving heparin during the procedure. The physician suspected that it was not a blood clot that led to the cerebral infarction but rather a foreign substance. The exact cause of the incident remains unknown. 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 | 9710452-2019-00005 |
| MDR Report Key | 8441949 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-03-21 |
| Date of Report | 2019-03-21 |
| Date of Event | 2019-01-29 |
| Date Mfgr Received | 2019-02-20 |
| Date Added to Maude | 2019-03-21 |
| 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 | 2019-03-21 |
| Model Number | NRG-E-HF-71-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. Hospitalization; 2. Other | 2019-03-21 |