MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-07-19 for NRG TRANSSEPTAL NEEDLE NRG-E-HF-98-C1 manufactured by Baylis Medical Company Inc..
[114538320]
There is no suspected device failure. Review of the device history record for the lot in question confirmed all parts met manufacturing requirements prior to release. The reported patient complication is an inherent risk to this type of procedure. There is no evidence to suggest that the baylis medical device caused or contributed to the reported incident. This report is being submitted as the baylis medical device was among the many devices used during the procedure.
Patient Sequence No: 1, Text Type: N, H10
[114538321]
The baylis medical nrg transseptal needle (rf needle) together with the st. Jude agilis introducer was used for transseptal puncture in a procedure. After some time following the second transseptal puncture, pericardial effusion was observed. The rf needle, st. Jude agilis introducer, and biosense mapping catheter were in the patient when the effusion was observed. The patient was transferred to the operating room. The procedure was aborted due to the procedural complication. There is no evidence to suggest that the baylis medical device caused or contributed to the reported incident. This report is being submitted as the baylis medical device was among the many devices used during the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710452-2018-00027 |
| MDR Report Key | 7705431 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-07-19 |
| Date of Report | 2018-07-19 |
| Date of Event | 2018-06-21 |
| Date Mfgr Received | 2018-06-21 |
| Date Added to Maude | 2018-07-19 |
| 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 | 2018-07-19 |
| Model Number | NRG-E-HF-98-C1 |
| Catalog Number | NRG-E-HF-98-C1 |
| Lot Number | NGFA080517 |
| 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 | 2018-07-19 |