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 Codes	Hematoma (1884); Low Blood Pressure/ Hypotension (1914); Retroperitoneal Hemorrhage (4483)
Date of Event	02/02/2026
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 from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a hematoma occurred.During a left atrial appendage closure (laac) procedure, an nrg transseptal needle was selected for use.The patient had a tortuous groin.During the procedure, a non-boston scientific dilator was used to dilate the patient's vein.A non-bsc sheath with nrg needle were used.The needle was used to cross the septum with no issues with transesophageal echocardiography (tee) and fluoroscopy guidance.After crossing the septum, the watchman sheath was inserted.The patient's blood pressure (bp) dropped, and the procedure was completed successfully.A computed tomography (ct) scan was performed after the implant procedure.The ct showed a retroperitoneal bleed at the iliac.The patient was admitted for observation and is expected to fully recover.The device is not expected to be returned for analysis.
Event or Problem Description
It was reported that a hematoma occurred.During a left atrial appendage closure (laac) procedure, a nrg transseptal needle was selected for use.The patient had a tortuous groin.During the procedure, a non-boston scientific dilator was used to dilate the patient's vein.A non-bsc sheath with nrg needle were used.The needle was used to cross the septum with no issues with transesophageal echocardiography (tee) and fluoroscopy guidance.After crossing the septum, the watchman sheath was inserted.The patient's blood pressure (bp) dropped, and the procedure was completed successfully.A computed tomography (ct) scan was performed after the implant procedure.The ct showed a retroperitoneal bleed at the iliac.The patient was admitted for observation and is expected to fully recover.The device is not expected to be returned for analysis.It was further reported that the patient was discharged and recovered.
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.
Additional Manufacturer Narrative
Device technical analysis: it was indicated that the device was disposed; therefore, a technical analysis of the complaint device could not be completed.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: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk analysis: a review of the nrg transseptal needle risk documentation was completed and confirmed that the event of hypotension, hemorrhage, hematoma were defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on the information provided, the reported event of hypotension, hemorrhage, hematoma are a known inherent risk of the nrg transseptal needle device.Hypotension, hemorrhage, hematoma are an expected procedural complication addressed within the ifu for the nrg transseptal needle.
Event or Problem Description
It was reported that a hematoma occurred.During a left atrial appendage closure (laac) procedure, a nrg transseptal needle was selected for use.The patient had a tortuous groin.During the procedure, a non-boston scientific dilator was used to dilate the patient's vein.A non-bsc sheath with nrg needle were used.The needle was used to cross the septum with no issues with transesophageal echocardiography (tee) and fluoroscopy guidance.After crossing the septum, the watchman sheath was inserted.The patient's blood pressure (bp) dropped, and the procedure was completed successfully.A computed tomography (ct) scan was performed after the implant procedure.The ct showed a retroperitoneal bleed at the iliac.The patient was admitted for observation and is expected to fully recover.The device is not expected to be returned for analysis.It was further reported that the patient was discharged and recovered.

• 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: 24401789
• Report Number: 2124215-2026-09567
• Device Sequence Number: 13226330
• Product Code: DXF
• UDI-Device Identifier: 00685447000204
• UDI-Public: (01)00685447000204(17)281020(10)37790905
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 04/17/2026

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: 0037790905
• 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: 02/02/2026
• Supplement Date Received by Manufacturer: 02/13/2026; 03/27/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 02/26/2026; 04/17/2026
• Date Device Manufactured: 10/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Female