MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-10-17 for NRG TRANSSEPTAL NEEDLE manufactured by Baylis Medical Company Inc..
[124066516]
There is no suspected device failure. The reported patient complication is an inherent risk in this type of procedure.
Patient Sequence No: 1, Text Type: N, H10
[124066517]
The manufacturer was informed of an incident involving inadvertent perforation in a patient during a transseptal procedure in which the nrg transseptal needle (rf needle) was used. During the procedure, 2-3 applications of rf energy were applied but transseptal crossing was unsuccessful. While readjusting the torflex transseptal guiding sheath and pulling back of the rf needle, the rf needle unexpectedly crossed the septum. The posterior wall of the left atrium was inadvertently perforated. The torflex sheath was left in place. After removing the rf needle, the physician tried to place a protrack pigtail wire into the pericardial space. Once this was unsuccessful, the physician took an extra small safari wire and brought it into the pericardial sac. With the safari in place, the torflex sheath was removed and a 5fr straight pigtail catheter was brought in the pericardial sac and a contrast injection was made to confirm the placement of the catheter. After this, a pericardial drain was put in place to remove the effusion and the physician proceeded to successfully place a 24mm watchman device. The patient was reported to be doing well 45 days following the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710452-2018-00038 |
| MDR Report Key | 7975603 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-10-17 |
| Date of Report | 2018-10-17 |
| Date of Event | 2018-08-01 |
| Date Mfgr Received | 2018-09-19 |
| Date Added to Maude | 2018-10-17 |
| 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 | 2018-10-17 |
| 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 | 2018-10-17 |