MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-05-23 for NRG TRANSSEPTAL NEEDLE NRG-71-C1 manufactured by Baylis Medical Company Inc..
[145992126]
Review of the device history record for the lot in question confirmed that all parts met manufacturing requirements prior to release. There is no evidence to suggest that the baylis medical device caused or contributed to the reported incident. However, as the baylis medical device was reported to be among the devices used in the procedure, baylis medical has decided to submit this report. 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
[145992127]
Baylis medical was informed of a pulmonary vein isolation (pvi) procedure in which the nrg transseptal needle was used for transseptal puncture and a complication occurred. The physician performed two transseptal punctures with the nrg needle through a sl1 sheath with no issue. The physician pulled out the nrg needle to exchange for an agilis sheath. No baylis products were used again or placed inside the patient. The physician lost access with the agilis sheath but was later able to cross again through the same puncture site. The case proceeded and later, a perforation was discovered. The patient was deemed stable and did not have to leave the catheterization lab but the procedure was aborted. The nursing staff indicated that the physician felt that the baylis nrg transseptal needle nrg needle was not responsible for the perforation. The nursing staff stated that very high contact force was observed on the mapping system throughout the procedure. There is no evidence to suggest that the baylis medical device caused or contributed to the reported incident. However, as the baylis medical 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 | 9710452-2019-00016 |
| MDR Report Key | 8637312 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-05-23 |
| Date of Report | 2019-05-23 |
| Date of Event | 2019-04-23 |
| Date Mfgr Received | 2019-04-25 |
| Date Added to Maude | 2019-05-23 |
| 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. EAST |
| 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 | 2019-05-23 |
| Returned To Mfg | 2019-05-16 |
| Model Number | NRG-71-C1 |
| Lot Number | NGFA110918 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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. Other | 2019-05-23 |