FDA Adverse Event
Malfunction
Summary report: N
NRG TRANSSEPTAL NEEDLE
MDR report key: 11286720
·
Received February 5, 2021
Report
- Report Number
- 9710452-2021-00006
- Event Type
- Malfunction
- Date Received
- February 5, 2021
- Date of Event
- January 6, 2021
- Report Date
- February 5, 2021
- Manufacturer
- BAYLIS MEDICAL COMPANY INC.
- Product Code
- DXF
- PMA / PMN Number
- K073326
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THERE WAS NO PATIENT IMPACT OR CONSEQUENCE. BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT DUE TO THE PROCEDURAL DELAY THAT OCCURRED .
Description of Event or Problem · 1
THE BAYLIS RADIOFREQUENCY PERFORATION GENERATOR SHOWED A HIGH IMPEDANCE CODE WHEN THE NRG TRANSSEPTAL NEEDLE WAS USED TO ATTEMPT RF DELIVERY, RESULTING IN A 20-MINUTE DELAY IN THE PROCEDURE. A NEW NRG TRANSSEPTAL NEEDLE WAS USED AND THE TRANSSEPTAL ACCESS WAS ACHIEVED SUCCESSFULLY. BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT DUE TO THE PROCEDURAL DELAY OF 20 MINUTES THAT OCCURRED FOR THIS PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 186715 | NRG TRANSSEPTAL NEEDLE | RF TRANSSEPTAL NEEDLE | DXF | BAYLIS MEDICAL COMPANY INC. | NRG-E-HF-98-C1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |