MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-07-26 for NRG TRANSSEPTAL NEEDLE NRG-E-HF-71-C0 manufactured by Baylis Medical Company Inc..
[115188826]
The reported patient complication is an inherent risk to this type of procedure.
Patient Sequence No: 1, Text Type: N, H10
[115188827]
A report was received indicating that tamponade occurred in patient during an ablation procedure in which the baylis medical nrg transseptal needle (rf needle) was used for transseptal puncture. Successful transseptal puncture was achieved with the rf needle using the baylis rf generator (pulse setting of 1 second). However, the rf needle inadvertently perforated the posterior wall. The distal tip of the rf needle was confirmed to be protruding from the cardiac silhouette by fluoroscopy. The rf needle was removed from the patient and pericardiocentesis was performed. Following confirmation that the patient was in stable condition, the ablation procedure continued and was completed without further complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710452-2018-00029 |
| MDR Report Key | 7724553 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-07-26 |
| Date of Report | 2018-07-26 |
| Date of Event | 2016-04-05 |
| 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 |
| Model Number | NRG-E-HF-71-C0 |
| Catalog Number | NRG-E-HF-71-C0 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 |