NRG Transseptal Needle NRG-E-HF-71-C1 (UDI 00685447000211)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00685447000211), received between Mar 26, 2019 and Sep 4, 2026 — classified as 2 deaths, 8 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• DeathSep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient death occurred.During a Faraview procedure, a NRG Transseptal Needle was selected for use. It was mentioned that the physician was only going to perform Pulmonary Vein Isolation and Posterior Wall Isolation with Farawave catheter. The patient was placed under general anesthesia. Physician started the punctures at around 6pm for the catheters and intracardiac echocardiography (ICE) catheter. Another physician was as performing transthoracic ultrasound during the whole length of the procedure. The doctors placed the Coronary Sinus catheter and proceeded to perform the transeptal puncture using NRG and Torflex. Ultrasound was performed to do the puncture and soon after, the RF was applied and the dilator was advanced. The Physician motioned that there was some fluid around the heart in the ultrasound. It was also mentioned that patient experienced a cardiac arrest. Pericardiocentesis was performed but the patient started to deteriorate. Patient coded and the doctors started performing CPR, called for the respiratory therapy specialists and a cardiac surgeon, who performed a thoracotomy but finally after 30min of CPR, blood transfusion, plasma, one cardio

  Patient problems: Cardiac Arrest; Cardiac Perforation; Cardiac Tamponade; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50600131 ↗
• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A CARDIAC PERFORATION AND PERICARDIAL EFFUSION (PE) OCCURRED. DURING A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A NRG TRANSSEPTAL NEEDLE AND TORFLEX GUIDING SHEATH WAS SELECTED FOR USE. A J-TIP GUIDEWIRE WAS INSERTED INTO THE FEMORAL ACCESS TO THE SUPERIOR VENA CAVA (SVC). THE TORFLEX SHEATH WAS ADVANCED OVER THE WIRE AND THE GUIDEWIRE WAS EXCHANGED FOR THE NRG NEEDLE. THE PHYSICIAN DROPPED DOWN ONTO THE FOSSA USING STANDARD TRANSSEPTAL TECHNIQUE BUT FELL TOO LOW. HENCE, THE PHYSICIAN REQUESTED FOR THE GUIDEWIRE TO WIRE BACK AGAIN INTO THE SVC. THE RT HANDED A NON-BOSTON SCIENTIFIC PIGTAIL WIRE INSTEAD WHICH GOT STUCK IN TORFLEX DILATOR. THE PHYSICIAN PULLED OUT THE ENTIRE SYSTEM. SINCE THERE WAS NO NEW TORFLEX SHEATH, A NON-BOSTON SCIENTIFIC SHEATH WAS USED AS A REPLACEMENT. THE J-TIP RE-ADVANCED WITH THE SHEATH OVER IT, POSITIONED ONTO AN INFERIOR-POSTERIOR POSITION ON THE SEPTUM. THE RADIO FREQUENCY WAS DELIVERED USING NRG AND THE TRANSSEPTAL WAS PERFORMED SUCCESSFULLY. THE PHYSICIAN SWAPPED OUT THE NEEDLE FOR THE NON-BOSTON SCIENTIFIC WIRE AND NOTICED THAT IT ADVANCED IN A STRANGE POSITION ON FLUORO AND PULLED BACK. IT WAS THEN RE-ADVANCED INTO T

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 20621252 ↗
• InjuryMay 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE. A PERFORATION WAS REPORTED. THE PROCEDURE WAS CANCELLED. DURING A WATCHMAN LAAC PROCEDURE, WHILE ATTEMPTING THE TRANSSEPTAL PUNCTURE, THE NRG NEEDLE PUNCTURED THE AORTIC ROOT. THE SET UP FOR TRANSSEPTAL WAS NORMAL FLOW, AND THE PHYSICIAN SAW A VISIBLE TENT IN THE SEPTUM BEFORE APPLY ENERGY TO THE NRG. AFTER ENTRY WAS APPLIED THE AIR/BUBBLE ARTIFACT WAS APPARENT IN THE AORTA, MAINTAINED POSITION AND CALLED FOR SURGICAL BACKUP. THUS, THE PROCEDURE WAS CANCELLED. THE PATIENT WAS HEMODYNAMICALLY STABLE, AND WAS TAKEN TO THE SURGERY ROOM FOR REPAIR. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. THE PATIENT WAS ADMITTED TO HOSPITAL BEYOND STANDARD OF CARE AND PATIENT DID GOOD, AND IT HAS BEEN DISCHARGED. IT WAS FURTHER CONFIRMED THAT NO PERFORATION NOR PERICARDIAL EFFUSION WAS NOTED PRIOR TO PROCEDURE. ALSO, THERE WERE MULTIPLE PACEMAKER WIRES TO WORK AROUND TO GET TO SEPTUM. NO MALFUNCTIONS NOTED WITH THE DEVICE. IN THE PHYSICIAN'S OPINION, THE NRG NEEDLE HAS CONTRIBUTED TO THE PERFORATION, DUE TO ITS USAGE.

  Patient problems: Perforation of Vessels

  MAUDE report 19255749 ↗
• MalfunctionApr 23, 2024Material Integrity Problem; Material Integrity Problem

  IT HAS BEEN REPORTED THAT AN NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE FOR AN UNKNOWN PROCEDURE. IT WAS MENTIONED THAT THE NEEDLE WAS BROKEN/SNAPPED BEFORE USING OR TOUCHING IT. PROCEDURE OUTCOME WAS NOT PROVIDED. NO PATIENT COMPLICATIONS WERE REPORTED. PRODUCT IS NOT EXPECTED TO RETURN FOR ANALYSIS. (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19164335 ↗
• MalfunctionMar 15, 2024Device Markings/Labelling Problem; Adverse Event Without Identified Device or Use Problem; Device Markings/Labelling Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN NRG TRANSSEPTAL NEEDLE EXPERIENCED AN ISSUE WITH THE LABEL BEING TORN. NO PATIENT COMPLICATIONS REPORTED. DEVICE AND PROCEDURE OUTCOME ARE UNKNOWN. PRODUCT IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18914426 ↗
• InjuryNov 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A NRF RF NEEDLE WAS SELECTED FOR USE DURING A WATCHMAN PROCEDURE. PHYSICIAN WAS DRAGGING THE NRG NEEDLE FROM SUPERIOR VENA CAVA INTO SEPTUM. THEN, PATIENT WENT INTO ASYSTOLE. COMPRESSIONS STARTED. A TEMPORARY PACEMAKER WAS INSERTED. THUS, THE WATCHMAN PROCEDURE CONTINUED AND IT WAS COMPLETED SUCCESSFULLY. THE TEMP PACEMAKER WAS LEFT IN PLACE. NO OTHER PATIENT COMPLICATIONS WERE NOTED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). THE PATIENT IS FULLY RECOVERED. THE CURRENT STATUS IS UNKNOWN. NO ISSUE WAS NOTED WITH THE NRG NEEDLE. THE SEPTUM WAS CROSSED WITH NO ISSUES AFTER THE INTERVENTION. THERE WERE TWO ATTEMPTS TO CROSS THE SEPTUM, AND RF WAS APPLIED ONCE, WITH THE SAME NRG NEEDLE. NOTHING UNUSUAL ABOUT THE PATIENT ANATOMY WAS NOTED. IN THE PHYSICIANS OPINION, THE DEVICE CONTRIBUTES TO THE PATIENT COMPLICATION, SINCE THE PATIENT WENT ASYSTOLE WHEN TRYING TO CROSS THE SEPTUM.

  Patient problems: Cardiac Arrest

  MAUDE report 18237579 ↗
• MalfunctionSep 25, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT HAS BEEN REPORTED THAT AN NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE FOR AN UNKNOWN PROCEDURE. IT HAS BEEN MENTIONED THAT THE USER EXPERIENCED AN ISSUE WHERE THE NEEDLE WAS EXPOSED TO FOREIGN MATERIAL. NO PATIENT COMPLICATIONS REPORTED. DEVICE AND PROCEDURE OUTCOME ARE UNKNOWN. PRODUCT IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17813320 ↗
• MalfunctionSep 25, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT HAS BEEN REPORTED THAT AN NRG TRANSSEPTAL NEEDLE EXPERIENCED AN ISSUE WHERE IT WAS EXPOSED TO FOREIGN MATERIAL. NO PATIENT COMPLICATIONS REPORTED. DEVICE AND PROCEDURE OUTCOME ARE UNKNOWN. PRODUCT IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17812834 ↗
• InjuryAug 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERICARDIAL EFFUSION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS ATTEMPTED USING A WATCHMAN TRUSEAL ACCESS SYSTEM (WAS). TRANSSEPTAL PUNCTURE (TSP) WAS PERFORMED WITH A NRG TRANSSEPTAL NEEDLE. PERICARDIAL EFFUSION (PE) WAS DISCOVERED SHORTLY AFTER THE TSP AND THE WAS CROSSING THE INTERATRIAL SEPTUM. THE PE INCREASED IN SIZE AND THE PATIENT BECAME HYPOTENSIVE. AFTER A PERICARDIAL DRAIN WAS PLACED, BLOOD WAS RECIRCULATED TO THE PATIENT. THE ACTIVATED COAGULATION TIME (ACT) OF THE PATIENT WAS 368 SECONDS AT THIS POINT IN THE PROCEDURE. 720ML OF BLOOD WAS DRAINED AND PROTAMINE WAS ADMINISTERED. FOLLOWING ADMINISTRATION OF PROTAMINE AN ADDITIONAL 180ML OF BLOOD WAS DRAINED. AFTER THIS ADDITIONAL BLOOD WAS DRAINED THE ACT OF THE PATIENT WAS 116 SECONDS. A FURTHER 10ML OF BLOOD WAS DRAINED AND THE LAA CLOSURE PROCEDURE WAS ABORTED. AT AN UNSPECIFIED TIME FOLLOWING THE PROCEDURE A PERICARDIAL WINDOW WAS PLACED. SIX DAYS POST INDEX PROCEDURE THE PATIENT FULLY RECOVERED AND WAS DISCHARGED.

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 17646786 ↗
• MalfunctionJul 12, 2023Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT A NRG RF NEEDLE WAS SELECTED FOR USE DURING A PULMONARY VEIN ISOLATION PROCEDURE. DURING THE PROCEDURE, THE NRG NEEDLE FAILED TO CROSS THE SEPTUM, DESPITE DELIVERY OF THE RADIO FREQUENCY AND SOUND GIVEN AT THE TIME. THUS, THE NRG NEEDLE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17312434 ↗
• InjuryJun 20, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED DURING A WATCHMAN PROCEDURE, A BMC NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE. THE TRANSSEPTAL WAS ATTEMPTED FOR 20 MINUTES, CROSSING ONCE, SYSTEM CAME BACK. PERICARDIAL EFFUSION WAS NOTED DURING PRE TRANSSEPTAL. THEN TRIED LONGER, IT WAS NOTICED A PERICARDIAL EFFUSION LARGER THAN PRIOR. IT WAS NOTED ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) THAT A TRACE AROUND THE HEART TO START RIGHT SIDE AND APPEARED TO BE GETTING LARGER OVER TIME. PRESUMED CAUSE WAS CROSSING TOO POSTERIOR OR PUNCTURING THE RIGHT AORTIC ARCH (RAA) WITH THE NON-BOSTON SCIENTIFIC SHEATH. PERICARDIAL EFFUSION LOCATION WAS AT RIGHT ATRIUM AND VENTRICLE. THERE WAS A CARDIAC TAMPONADE, PATIENT WAS STABLE THROUGHOUT, LOW BLOOD PRESSURE WAS NOTED. PHYSICIAN IS NOT SURE IF IT WAS LOCATION OF TRANSSEPTAL PUNCTURE OR MULTIPLE MANEUVERS AND RE-WIRES TO THE SUPERIOR VENA CAVA (SVC). SMALL EFFUSION NOTED PRIOR TO PROCEDURE, SIZE WAS NOT NOTED. AFTER THE PROCEDURE, THE EFFUSION WAS NOTICEABLY LARGER AND GOT LARGER. THERE WAS DIFFICULTY GETTING TRANSSEPTAL, SEEING TENT ON SEPTUM ON IMAGING. MULTIPLE ATTEMPTS REQUIRED TO TRACK UP / DROP DOWN INTO POSITION ON SEPTUM BEFORE TRANSSEPTAL PUNCTURE WAS PERFORMED. PHYSIC

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension; Perforation; Pericardial Effusion

  MAUDE report 17163331 ↗
• MalfunctionJun 9, 2023Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT A NRG RF NEEDLE WAS SELECTED FOR USE DURING AN UNKNOWN PROCEDURE. DURING THE TRANSSEPTAL PUNCTURE, THE FOOTSWITCH WAS STEPPED ON, HOWEVER THE NRG NEEDLE DID NOT ENERGIZE. ANOTHER RE-STERILIZED CABLE WAS USED (REPLACED), BUT THE SITUATION DID NOT CHANGE; THEREFORE, THE RF NEEDLE WAS REPLACED AND THE PROCEDURE WAS PERFORMED. IT IS NOT A REPROCESSED NEEDLE. NO ISSUE WAS NOTED WITH THE FOOTSWITCH. NO ALERT/ERROR WAS DISPLAYED WHEN RF WAS ATTEMPTED. AT THIS TIME, IT HAS BEEN HEARD A "BEEP" SOUND TWICE ONCE TRYING TO DELIVER RF. THE PROCEDURE AND INDICATION WAS A TRANSSEPTAL. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17100348 ↗
• MalfunctionJun 8, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING A TRANSSEPTAL PROCEDURE, A BMC NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE. HOWEVER WHEN THE PHYSICIAN WAS TRYING TO REMOVE AIR PRIOR TO USE IN THE PATIENT, IT COULD NOT BE COMPLETED DUE TO THE LUER CONNECTOR BEING LOOSE WHICH CAUSED THE SALINE SOLUTION TO LEAK. IT WAS BELIEVED THAT THE SYRINGE SIDE OF THE DEVICE DID NOT SEEM TO BE AFFECTED. THE FLUID WAS LEAKING FROM THE CONNECTION PART BETWEEN THE LUER CONNECTOR AND THE SYRINGE. HENCE, THE DEVICE WAS REPLACED AND THE CONNECTION WAS MADE SECURELY. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED IN THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17089006 ↗
• InjuryJan 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A VENTRICULAR TACHYCARDIA ABLATION IN A PATIENT WITH PARAPLÉGIA, A HEMOTHORAX OCCURRED. THERE WAS NO POSSIBILITY TO USE FEMORAL ACCESS AND RETRO AORTIC ACCESS WAS NOT AN OPTION EITHER DUE TO AN AORTIC MECHANICAL VALVE. THEREFORE, THE PHYSICIAN DECIDED TO USE THE JUGULAR VENOUS APPROACH AND TRANSSEPTAL TO ACCESS THE LEFT VENTRICLE (LV). THE FIRST INTENT WAS TO PERFORM A VENTRICULAR TRANSSEPTAL BUT THE PHYSICIAN WAS NOT ABLE TO PASS THROUGH THE TRICUSPID VALVE. THE SECOND ATTEMPT WAS TO PERFORM AN ATRIAL TRANSSEPTAL, USING AGILIS EPI AND BAYLIS NEEDLE, BUT STABILITY WAS POOR. TRANSESOPHAGEAL ECHOCARDIOGRAPHY WAS USED IN BOTH CASES. THE PHYSICIAN THEN DECIDED TO PERFORM A TRANS-APICAL PUNCTURE, DIRECTLY THROUGH THE LV APEX. AGILIS EPI WAS INSERTED INTO THE LV AND AN HD GRID AND THEN THE TACTICATH CATHETER WAS USED TO MAP THE LV AND VENTRICULAR TACHYCARDIA. THE PATIENT WAS STABLE THROUGHOUT THE ENTIRE CASE. MAPPING AND ABLATION COULD BE PERFORMED WITHOUT ANY HEMODYNAMICAL ISSUE. THE PHYSICIAN DECIDED TO REMOVE THE CATHETERS AND CLOSED THE PUNCTURE USING A FEMOSEAL DEVICE; NO BLOOD LEAKAGE WAS OBSERVED. SHORTLY AFTER, SATURATION LOWERED AND ANALYSIS CONFIRMED A HEMOTHORAX, WITH B

  Patient problems: Hemothorax

  MAUDE report 13286056 ↗
• InjuryFeb 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CASE OF PERICARDIAL EFFUSION WAS REPORTED DURING A PROCEDURE WHERE THE VERSACROSS RF WIRE, VERSACROSS TRANSSEPTAL SHEATH, NRG TRANSSEPTAL NEEDLE AND TORFLEX TRANSSEPTAL GUIDING SHEATH WERE USED. THE PATIENT HAD AN EXISTING PERICARDIAL EFFUSION THAT GREW DURING THE PROCEDURE DUE TO A SUSPECTED RIGHT ATRIUM PUNCTURE. THE PROCEDURE WAS ABORTED AND A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT STABILIZED AND WAS KEPT OVERNIGHT. THERE IS NO EVIDENCE TO SUGGEST THAT THE BAYLIS MEDICAL DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. HOWEVER, AS A BAYLIS MEDICAL DEVICE WAS REPORTED TO BE AMONG THE DEVICES USED IN THE PROCEDURE, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT. SEPARATE PROBLEM REPORTS HAVE BEEN SUBMITTED FOR THE VERSACROSS TRANSSEPTAL SHEATH, VERSACROSS RF WIRE AND TORFLEX TRANSSEPTAL GUIDING SHEATH.

  Patient problems: Pericardial Effusion

  MAUDE report 11278190 ↗
• DeathAug 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A WATCHMAN PROCEDURE IN WHICH THE NRG TRANSSEPTAL NEEDLE WAS USED FOR A TRANSSEPTAL PUNCTURE, A PATIENT EXPIRED. THE PATIENT HAD A HISTORY OF ANEMIA, PREVIOUS BLEEDS, AND AT THE TIME HAD A VERY LOW HEMOGLOBIN LEVEL. PRIOR TO THE PROCEDURE, THE PHYSICIAN NOTED A BASELINE EFFUSION IN THE PATIENT. THE PHYSICIAN USED THE NRG NEEDLE TO SUCCESSFULLY GO TRANSSEPTAL, BUT THEN LOST ACCESS. THE PHYSICIAN WENT TRANSSEPTAL A SECOND TIME. WHILE PREPARING FOR THE WATCHMAN PROCEDURE, THE PATIENT'S BLOOD PRESSURE BEGAN TO DROP. THE PHYSICIAN STUDIED THE EFFUSION CONTINUOUSLY AND DETERMINED THERE WAS NO INCREASE FROM THE BASELINE. THE ROOM WAS CLEARED AND THE PHYSICIAN INSERTED A HEART CATH. STUDIES SHOWED A POSSIBLE CLOT AND SEVERE PLAQUE BUILDUP IN THE RIGHT CORONARY ARTERY. THE PHYSICIAN CHOSE TO INSERT A PACEMAKER AND AN IMPELLA DEVICE. THE PHYSICIAN THEN CALLED OFF THE OPERATING ROOM STAFF. THE PHYSICIAN TOOK THE PATIENT OFF THE PACEMAKER AND STATED THAT THE PATIENT WAS STABLE. THE PATIENT EXPIRED LATER THAT NIGHT. THERE IS NO EVIDENCE TO SUGGEST THAT THE BAYLIS MEDICAL DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. HOWEVER, AS THE BAYLIS MEDICAL DEVICE WAS REPORTED TO BE AMO

  Patient problems: Death

  MAUDE report 8942504 ↗
• InjuryMar 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE NRG TRANSSEPTAL NEEDLE (NRG NEEDLE) AND TORFLEX TRANSSEPTAL GUIDING SHEATH (TFK) WERE USED FOR TRANSSEPTAL PUNCTURE IN A PROCEDURE. THE PHYSICIAN NOTICED AN EFFUSION ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE) FOLLOWING THE FIRST AND DURING THE SECOND TRANSSEPTAL PUNCTURE. THE PHYSICIAN USED AN AGILIS SHEATH AND 98 CM C1 NRG NEEDLE TO PERFORM THE FIRST TRANSSEPTAL PUNCTURE. THE PHYSICIAN WAS ABLE TO PUNCTURE ACROSS THE SEPTUM EASILY IN A SAFE POSITION IN THE MIDDLE OF THE SEPTUM VIA ICE. THE PHYSICIAN THEN PREPARED FOR THE SECOND TRANSSEPTAL USING THE 45 DEGREE TFK AND 71 CM C1 NRG NEEDLE. THE PHYSICIAN HAD SOME DIFFICULTY GETTING INTO THE CORRECT POSITION AND WAS IN A VERY POSTERIOR AND LOW POSITION WITH THE SHEATH AND DILATOR. THE NRG NEEDLE WAS NEVER EXPOSED IN THIS POSITION. THE PHYSICIAN THEN TORQUED THE SHEATH AND NEEDLE INTO A BETTER TENTING POSITION AND APPLIED RF ENERGY FOR 1 SECOND (CONSTANT). BEFORE PUTTING ANYTHING ACROSS THE SEPTUM OTHER THAN THE NRG NEEDLE, THE PHYSICIAN SCANNED ICE AND NOTICED A LARGE EFFUSION DEVELOPING. THE PHYSICIAN MONITORED THE EFFUSION FOR A FEW MINUTES AND DECIDED IN CONSULTATION WITH ANOTHER PHYSICIAN THAT A PERICARDIAL TAP WAS REQUIRED. ONCE

  Patient problems: Pericardial Effusion

  MAUDE report 8454008 ↗