MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-11-09 for NRG TRANSSEPTAL NEEDLE manufactured by Baylis Medical Company Inc..
[126891153]
There is no suspected device failure. The reported patient complication is an inherent risk in this type of procedure. There is no evidence to suggest that the baylis medical device caused or contributed to the reported complication. 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
[126891154]
A report was received from another manufacturer regarding an incident in which the baylis medical rf needle was used: "prior to vt ablation patient had lv aneurysm with trace effusion. Ablation performed at the mouth of the aneurysm. Patient's effusion slightly increased to 0. 75 cm at the end of the procedure. An echo performed after the procedure revealed significant increase to 1. 7cm with diastolic collapse of ra and rv. Pericardiocentesis performed. Pericardial drain was hemorrhagic and saturation was 54% suggestive of right sided perforation. Likely while performing transseptal puncture with ra wire getting difficult to cannulate svc due to adhesions of icd lead at the level of svc coil possibly may have caused perforation in ra appendage area. Slow bleed; after draining, pt doing well with good hemodynamics" there is no evidence to suggest that the baylis medical device caused or contributed to the reported complication. 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 | 9710452-2018-00040 |
| MDR Report Key | 8057417 |
| Report Source | OTHER |
| Date Received | 2018-11-09 |
| Date of Report | 2018-11-09 |
| Date of Event | 2018-09-20 |
| Date Mfgr Received | 2018-10-11 |
| Date Added to Maude | 2018-11-09 |
| 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 | 2018-11-09 |
| 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. Required No Informationntervention | 2018-11-09 |