MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-04-29 for NRG TRANSSEPTAL NEEDLE NRG-E-HF-71-C1 manufactured by Baylis Medical Company Inc..
[143537884]
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 medical 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
[143537885]
The nrg transseptal needle (rf needle) was used for transseptal puncture in an ablation procedure. After inserting the rf needle into the patient's right atrium via a swartz sl1 sheath, the physician had difficulty in positioning the needle tip to the atrial septum (the patient had hypertrophic cardiomyopathy). As the location of the atrial septum could not be confirmed on echocardiography, right atrial angiography was used. After transseptal puncture was achieved as a result of multiple rf energy deliveries, the rf needle was advanced and replaced with a guidewire. Then, it was observed that the patient's blood pressure had decreased and it was suspected that the aorta had been inadvertently damaged. Cardiac drainage was performed but blood was not drained. The hospital staff prepared for percutaneous cardiopulmonary support (pcps). However, the blood pressure and bleeding both became stable without the need for pcps. The procedure was aborted. There is no evidence to suggest that the baylis medical device caused or contributed to the reported incident. However, as the baylis medical 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 | 9710452-2019-00010 |
| MDR Report Key | 8562936 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-04-29 |
| Date of Report | 2019-04-29 |
| Date of Event | 2019-04-02 |
| Date Mfgr Received | 2019-04-05 |
| Date Added to Maude | 2019-04-29 |
| 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 | 2019-04-29 |
| Model Number | NRG-E-HF-71-C1 |
| Lot Number | NGFH060718 |
| 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 | 2019-04-29 |