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..
[115226385]
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
[115226386]
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. Article reference: pedersen m, leo m, kalla m, et al. Management of tamponade complicating catheter ablation for atrial fibrillation: early removal of pericardial drains is safe and effective and reduces analgesic requirements and hospital stay compared to conventional delayed removal. Jacc: clinical electrophysiology (2017); 3(4): 367-373. As per the article, "the authors performed a retrospective descriptive analysis of 43 cases of tamponade complicating afca from 2006 to 2015, comparing patients in whom the drain was removed early (group early removal (er); n 1/4 25) versus traditional delayed removal (group delayed removal [dr]; n 1/4 18)... Venous access was obtained via the femoral veins and a multipolar catheter placed in the coronary sinus (cs). In cases performed under general anesthesia, all transseptal punctures were carried out under transesophageal guidance. In cases carried out under sedation, 1 case was done with intracardiac echocardiography (ice probe, siemens, munich, germany) for transseptal puncture guidance, 1 was via a patent foramen ovale (pfo)/atrial septic defect (asd) and the remaining case was done with fluoroscopic guidance only. The punctures were done using either the brockenbrough (medtronic, inc. , minneapolis, minnesota), endrys (cook medical, bloomington, indiana) or the nrg rf (baylis medical, montreal, quebec, canada) transseptal needle through a long introducer sheath, usually the mullens (cook medical) or a sheath of the fast-cath transseptal guiding introducer sl series (st. Jude medical, austin, texas). At the operator's preference, either a second separate transseptal puncture was done or the ablation catheter was passed through a second sheath, usually an agilis (agilis nxt steerable introducer, st. Jude medical), and fed across the same initial puncture. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710452-2018-00030 |
| MDR Report Key | 7724552 |
| 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 |