MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION 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 Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	01/08/2026
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.Good faith effort attempts to try and retrieve additional details regarding the reported event are in progress, but further information was unable to be obtained.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that hypotension occurred.It was reported that during a pulmonary vein isolation procedure, a nrg transseptal needle was selected for use.It was noted that the patient blood pressure dropped prior to getting transeptal access.The patient was treated with vasopressors and blood pressure back to normal after extubating.The patient was admitted to intensive care unit for observation and is expected to fully recover.The device is not expected to be returned for analysis (disposed).
Additional Manufacturer Narrative
Due to additional information received, this supplemental report is being submitted for the updated field describe event or problem (b5), in section b - adverse event or product problem.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.
Event or Problem Description
It was reported that hypotension occurred.It was reported that during a pulmonary vein isolation procedure, a nrg transseptal needle was selected for use.It was noted that the patient blood pressure dropped prior to getting transeptal access.The patient was treated with vasopressors and blood pressure back to normal after extubating.The patient was admitted to intensive care unit for observation and is expected to fully recover.The device is not expected to be returned for analysis (disposed).It was further reported that the nrg was inside the body when hypotension was noted.No difficulty during transseptal was noted.The procedure was resumed after it was treated.Act was over 300-350.In the physician opinion, the device did not contribute to patient complication.The patient was discharged next day with no issues.
Additional Manufacturer Narrative
Investigation summary: based on the available information, although the product was disposed of and could not be returned, we have determined that the hypotension is a known inherent risk of use of this device.Device history record review: the manufacturing batch record review confirmed that the device met all material, assembly, and performance specifications.Device technical analysis: it was indicated the device is unavailable for return; therefore, a technical analysis of the complaint device could not be completed.Labeling review: based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use.Risk review: a risk review performed for the nrg transseptal needle device confirmed that the events of hypotension are known events defined in the product risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Product risk benefit includes consideration of risk severity and rate, and the overall residual risk of the nrg transseptal needle device is acceptable.Investigation conclusion: based on the information provided, the reported event of hypotension is a known inherent risk of the nrg transseptal needle device.Hypotension is an expected procedural complication addressed within the ifu for the nrg transseptal needle.There were no allegations of a quality or manufacturing deficiency leading to the adverse event as reported to bsc, and the device has not been returned for analysis at this time.
Event or Problem Description
It was reported that hypotension occurred.It was reported that during a pulmonary vein isolation procedure, a nrg transseptal needle was selected for use.It was noted that the patient blood pressure dropped prior to getting transeptal access.The patient was treated with vasopressors and blood pressure back to normal after extubating.The patient was admitted to intensive care unit for observation and is expected to fully recover.The device is not expected to be returned for analysis (disposed).It was further reported that the nrg was inside the body when hypotension was noted.No difficulty during transseptal was noted.The procedure was resumed after it was treated.Act was over 300-350.In the physician opinion, the device did not contribute to patient complication.The patient was discharged next day with no issues.

• Brand Name: NRG TRANSSEPTAL NEEDLE
• Common Device Name: CATHETER, SEPTOSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; multitenant #2, street #58 zon; cartago, 03 30106 ; CS 30106
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 24216026
• Report Number: 2124215-2026-05379
• Device Sequence Number: 9238566
• Product Code: DXF
• UDI-Device Identifier: 00685447000204
• UDI-Public: (01)00685447000204(17)281016(10)37769161
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 03/25/2026

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: 0037769161
• 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: 01/08/2026
• Supplement Date Received by Manufacturer: 01/27/2026; 02/27/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 02/12/2026; 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Race: White