NRG TRANSSEPTAL NEEDLE
Report
- Report Number
- 2124215-2024-43738
- Event Type
- Malfunction
- Date Received
- July 17, 2024
- Date of Event
- June 20, 2024
- Report Date
- September 27, 2024
- Manufacturer
- BAYLIS MEDICAL COMPANY INC.
- Product Code
- DXF
- PMA / PMN Number
- K073326
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AT BOSTON SCIENTIFIC'S POST MARKET LABORATORY, THE NRG RF NEEDLE WAS FIRST VISUALLY INSPECTED, AND IT PASSED FLUSHING TEST. HOWEVER, THE DEVICE FAILS FOR PROXIMAL END AND DISTAL TIP INTEGRITY, SINCE THERE WERE SIGNS OF MANUAL RESHAPING AT THE DISTAL END AND SHAFT OF THE NEEDLE. THERE WERE MULTIPLE BENDS/KINKS ALONG THE SHAFT OF THE NEEDLE. ALSO, THE DEVICE FAILED VISUAL TESTING, AS THE NEEDLE WAS MISSING THE CONNECTOR, AND CABLE HAD EVIDENCE OF BEING PULLED FROM THE HANDLE. FURTHER, THE NRF NEEDLE WAS INSPECTED WITH CURVE OVERLAY AND IT FAILED. FINALLY, THE DEVICE PASSED THE TEST FOR DISTAL HYPO TUBE OUTER DIAMETER. THE LABELING REVIEW WAS CONDUCTED, AND IT WAS DETERMINED IT IS POSSIBLE THAT THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE LABELLED INDICATIONS/INSTRUCTIONS FOR USE, WHICH WARNS THE USER TO 'DO NOT BEND THE NRG TRANSSEPTAL NEEDLE. EXCESSIVE BENDING OR KINKING OF THE NEEDLE TIP MAY DAMAGE THE INTEGRITY OF THE NEEDLE AND MAY CAUSE PATIENT INJURY. CARE MUST BE TAKEN WHEN HANDLING THE NEEDLE.' THE REPORTED ALLEGATION CAN BE CONFIRMED AS THE NEEDLE WAS FOUND TO BE KINKED/BENT DUE TO MANUAL RESHAPING DURING THE PROCEDURE, WHICH COULD ULTIMATELY AFFECT PROPER RF ENERGY DELIVERY.
IT WAS REPORTED THAT AN NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE FOR TRANSSEPTAL PUNCTURE FOR A PULMONARY VEIN ISOLATION (PVI) PROCEDURE. DURING THE PROCEDURE, IT WAS MENTIONED THAT NRG NEEDLE WAS NOT DELIVERING RF ENERGY WHEN PUSHING THE BUTTON ON THE BMC GENERATOR AND THEREFORE WAS UNABLE TO PERFORATE THE SEPTUM. MULTIPLE ATTEMPTS WERE MADE TO THE APPLY RF BUT CONTINUE TO BE UNSUCCESSFUL. THE PHYSICIAN WAS EVENTUALLY ABLE TO PERFORATE THE SEPTUM THROUGH A PATENT FORAMEN OVALE (PFO) BY ACCIDENT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE BMC GENERATOR WAS IN 'READY' MODE AND RF TONE WAS HEARD WHEN ENERGIZATION WAS ATTEMPTED. NO PATIENT COMPLICATIONS WERE REPORTED. THE GENERATOR DID NOT SHOW ANY ISSUES NOR ERRORS OR ALERTS, ALTHOUGH IT WILL BE RETURNING FOR ANALYSIS ALONG WITH NRG RF NEEDLE.
IT WAS REPORTED THAT AN NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE FOR TRANSSEPTAL PUNCTURE FOR A PULMONARY VEIN ISOLATION (PVI) PROCEDURE. DURING THE PROCEDURE, IT WAS MENTIONED THAT NRG NEEDLE WAS NOT DELIVERING RF ENERGY WHEN PUSHING THE BUTTON ON THE BMC GENERATOR AND THEREFORE WAS UNABLE TO PERFORATE THE SEPTUM. MULTIPLE ATTEMPTS WERE MADE TO THE APPLY RF BUT CONTINUE TO BE UNSUCCESSFUL. THE PHYSICIAN WAS EVENTUALLY ABLE TO PERFORATE THE SEPTUM THROUGH A PATENT FORAMEN OVALE (PFO) BY ACCIDENT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE BMC GENERATOR WAS IN 'READY' MODE AND RF TONE WAS HEARD WHEN ENERGIZATION WAS ATTEMPTED. NO PATIENT COMPLICATIONS WERE REPORTED. THE GENERATOR DID NOT SHOW ANY ISSUES NOR ERRORS OR ALERTS, ALTHOUGH IT WILL BE RETURNING FOR ANALYSIS ALONG WITH NRG RF NEEDLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2040433 | NRG TRANSSEPTAL NEEDLE | CATHETER, SEPTOSTOMY | DXF | BAYLIS MEDICAL COMPANY INC. | NGFD081223 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |