MAUDE Adverse Event Report: BAYLIS MEDICALE CIE INC NRG TRANSSEPTAL NEEDLE; CATHETER, SEPTOSTOMY

Model Number	NRG-E-HF-71-C0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	12/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a pericardial effusion (pe) occurred.The procedure was cancelled.During a pulse field ablation procedure indicated for a case of paroxysmal atrial fibrillation, a versacross access solution kit and a nrg rf needle were selected for use.The physician got placement in fossa and attempted to cross septum with versacross rf wire three times.Then, increased to two seconds constant however was still unable to cross transeptal.Hence, transeptal was obtained using a nrg transseptal needle and torflex sheath but later a pericardial effusion was discovered and required a pericardiocentesis.The procedure was cancelled.The nrg needle and versacross return are expected.In the physician opinion, since he could not cross with versacross and changed to nrg first time to cross septum and pe developed, he felt the nrg may have contributed to the adverse event.
Additional Manufacturer Narrative
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.A separate problem report will be filed for the versacross rf wire.
Additional Manufacturer Narrative
Due to additional information received, the initial mdr was updated in the blocks b5 (describe event or problem), f10 and h6 (patient codes).The device has been received for analysis.Upon 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.
Event or Problem Description
It was reported a pericardial effusion (pe) occurred.The procedure was cancelled.During a pulse field ablation procedure indicated for a case of paroxysmal atrial fibrillation, a versacross access solution kit and a nrg rf needle were selected for use.The physician got placement in fossa and attempted to cross septum with versacross rf wire three times.Then, increased to two seconds constant however was still unable to cross transeptal.Hence, transeptal was obtained using a nrg transseptal needle and torflex sheath but later a pericardial effusion was discovered and required a pericardiocentesis.The procedure was cancelled.The nrg needle and versacross return are expected.In the physician opinion, since he could not cross with versacross and changed to nrg first time to cross septum and pe developed, he felt the nrg may have contributed to the adverse event.It was further confirmed fluoroscopy and ice were used for visualization.It was attempted to cross with versacross four times, the versacross rf wire was protruding out of the dilator when attempting to cross and slight forward pressure was applied upon fourth attempt to cross.Tenting was seen mid anterior on the fossa.No malfunction was noted on the versacross only that it was unable to obtain crossing with application of rf.Physician felt that somehow it could have contributed to the patient's tamponade because it could not cross multiple times.Act was therapeutic.
Additional Manufacturer Narrative
The device was returned for analysis.Upon receipt at our post market quality assurance laboratory, the rf needle was visually inspected.The device passed flushing test (pre and post decontamination); the distal sideports of the needle as well as the luer at the handle appeared to be clear of debris and free of defects, and no visual damages were noted.Next, the device passed puncture test with rf needle and connector cable on a bench-top model.Also, the device passed the design specifications for the active tip length measurement, continuity test.Additionally, the design specification for the curve overlay inspection was not met which was due to the manual reshaping of the needle which was evident along the curve profile.There is no evidence to suggest the device did not meet design specifications, and device failure is not suspected.Therefore, the reported allegation related to pericardial effusion can't be confirmed.
Event or Problem Description
It was reported a pericardial effusion (pe) occurred.The procedure was cancelled.During a pulse field ablation procedure indicated for a case of paroxysmal atrial fibrillation, a versacross access solution kit and a nrg rf needle were selected for use.The physician got placement in fossa and attempted to cross septum with versacross rf wire three times.Then, increased to two seconds constant however was still unable to cross transeptal.Hence, transeptal was obtained using a nrg transseptal needle and torflex sheath but later a pericardial effusion was discovered and required a pericardiocentesis.The procedure was cancelled.The nrg needle and versacross return are expected.In the physician opinion, since he could not cross with versacross and changed to nrg first time to cross septum and pe developed, he felt the nrg may have contributed to the adverse event.It was further confirmed fluoroscopy and ice were used for visualization.It was attempted to cross with versacross four times, the versacross rf wire was protruding out of the dilator when attempting to cross and slight forward pressure was applied upon fourth attempt to cross.Tenting was seen mid anterior on the fossa.No malfunction was noted on the versacross only that it was unable to obtain crossing with application of rf.Physician felt that somehow it could have contributed to the patient's tamponade because it could not cross multiple times.Act was therapeutic.

• Brand Name: NRG TRANSSEPTAL NEEDLE
• Common Device Name: CATHETER, SEPTOSTOMY
• Manufacturer (Section D): BAYLIS MEDICALE CIE INC; 5959 trans-canada highway; montreal H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2775 matheson blvd east; mississauga, on L4W 4 P7; CA L4W 4P7
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 21001980
• Report Number: 2124215-2024-81458
• Device Sequence Number: 13221475
• Product Code: DXF
• UDI-Device Identifier: 00685447004523
• UDI-Public: 00685447004523
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K073326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: NRG-E-HF-71-C0
• Device Catalogue Number: NRG-E-HF-71-C0
• Device Lot Number: 0033436097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: 12/27/2024; 02/28/2025
• Initial Report FDA Received Date: 12/23/2024
• Supplement Report FDA Received Date: 01/15/2025; 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Hospitalization
• Patient Sex: Unknown