MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,litera report with the FDA on 2018-07-26 for NRG TRANSSEPTAL NEEDLE manufactured by Baylis Medical Company Inc..
[115186925]
The reported patient complication is an inherent risk to this type of procedure. There is no evidence to suggest the baylis medical devices caused or contributed to the reported complications. However, as the baylis devices were among the several devices used in the procedures, baylis medical has decided to submit this report.
Patient Sequence No: 1, Text Type: N, H10
[115186926]
During a periodic review of published literature by the manufacturer, baylis medical devices were identified among several other manufacturers' devices as having been used in procedures with reported complications. There is no evidence to suggest the baylis medical devices caused or contributed to the reported complications. However, as the baylis devices were among the several devices used in the procedures, baylis medical has decided to submit this report. Article reference: arkles j, zado e, supple g, et al. Feasibility of transseptal access in patients with previously scarred or repaired interatrial septum. Journal of cardiovascular electrophysiology (2015); 26(9): 963-968. As per the article, "our standard equipment until 2006 consisted of 2 mullins sheaths (medtronic, inc. , (b)(4), usa) that were serially deployed in the (b)(4) with standard brokenbrough (brk) needles; the ablation and circular mapping catheter were advanced in the (b)(4) through these sheaths. Beginning in 2007, we switched to the agilis nxt deflectable sheath and sl-1 sheath (both st. Jude medical inc. , (b)(4), usa) with accompanying brk or brk-1 needles. The agilis sheath was typically deployed with the 1st tsp and the sl-1 sheath was deployed during the 2nd tsp. In the event that tsp was unsuccessful despite using cautery with the conventional needle, the latter was exchanged for one of the alternative needle platforms including the safesept transseptal guidewire (pressure products, (b)(4), usa) or the nrg transseptal needle (baylis, (b)(4), usa)... A 1% (n = 6) rate of complications in this group, all of which were pericardial effusions. Three of these pericardial effusions required pericardiocentesis and 3 were managed conservatively; none required cardiac surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710452-2018-00031 |
| MDR Report Key | 7724549 |
| Report Source | COMPANY REPRESENTATIVE,LITERA |
| Date Received | 2018-07-26 |
| Date of Report | 2018-07-26 |
| Date Mfgr Received | 2018-06-28 |
| Date Added to Maude | 2018-07-26 |
| 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. EEAST |
| 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 | 2018-07-26 |
| 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 | 2018-07-26 |