MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NRG TRANSSEPTAL NEEDLE; CATHETER, SEPTOSTOMY

Model Number	NRG-E-HF-98-C1
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	11/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.Detailed product information was not provided to bsc.Good faith efforts to obtain the information are in progress.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information at this time.A supplemental report will be filed if the information is received.
Event or Problem Description
It was reported that a patient experienced pericardial effusion.The physician performed a pulse field ablation (pfa) for atrial fibrillation.The transseptal puncture with an nrg needle was challenging.After the case, a pericardial effusion beyond baseline was noted.The patient was monitored for 10 minutes and the physician decided to perform a pericardiocentesis.500 ml of fluid was removed from the pericardium without incident.The blood pressure of the patient stabilized, but the patient was admitted to the intensive care unit (icu) for closer monitoring.The patient was expected to fully recover.The physician believed that this event may have happened during transseptal puncture.The device is not expected to return for analysis as it was disposed.The patient was discharged home two days after the incident.The physician believed that this event may have been related to the coronary sinus (cs) catheter.The physician could not place the cs catheter into the cs and notable effort was reported to place the catheter.
Additional Manufacturer Narrative
B5: describe event or problem - updated h6: impact codes- updated it was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was unable to be obtained.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information.
Event or Problem Description
It was reported that a patient experienced pericardial effusion.The physician performed a pulse field ablation (pfa) for atrial fibrillation.The transseptal puncture with an nrg needle was challenging.After the case, a pericardial effusion beyond baseline was noted.The patient was monitored for 10 minutes and the physician decided to perform a pericardiocentesis.500ml of fluid was removed from the pericardium without incident.The blood pressure of the patient stabilized, but the patient was admitted to the intensive care unit (icu) for closer monitoring.The patient was expected to fully recover.The physician believed that this event may have happened during transseptal puncture.The device is not expected to return for analysis as it was disposed.The patient was discharged home two days after the incident.The physician believed that this event may have been related to the coronary sinus (cs) catheter.The physician could not place the cs catheter into the cs and notable effort was reported to place the catheter.It was further reported that the blood pressure of the patient stabilized after doing the pericardiocentesis but still required support from medications for a few hours after being transferred to icu.The patient was hypotensive but responded to medications.The lowest systolic blood pressure noted was in the 80s.The cs catheter was a non-boston scientific (bsc) device.

• Brand Name: NRG TRANSSEPTAL NEEDLE
• Common Device Name: CATHETER, SEPTOSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 23782370
• Report Number: 2124215-2025-90444
• Device Sequence Number: 15809713
• Product Code: DXF
• UDI-Device Identifier: 00685447000259
• UDI-Public: (01)00685447000259
• 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
• Report Date (Section B): 12/30/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: NRG-E-HF-98-C1
• Device Catalogue Number: NRG-E-HF-98-C1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 12/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BSW CS CATHETER.; CS CATHETER.; FARAWAVE CATHETER.; FARAWAVE CATHETER.; VIZIGO WIRE.; VIZIGO WIRE.
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Race: White