NRG Transseptal NeedleRecalls & reported problems across all models

We found 8 models of NRG Transseptal Needle by Baylis Médicale Cie Inc in the FDA's device registry (GUDID). Together they are named in 29 adverse event reports in the FDA's MAUDE database, received between May 23, 2019 and Aug 4, 2026 — classified as 1 death, 18 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (5 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported NRG Transseptal Needle problems

NRG Transseptal Needle models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• NRG Transseptal Needle NRG-E-HF-71-C1

  Catheter, Septostomy
  16 reports
• NRG Transseptal Needle NRG-E-HF-71-C0

  Catheter, Septostomy
  7 reports
• NRG Transseptal Needle NRG-71-C1

  Catheter, Septostomy
  1 report
• NRG Transseptal Needle NRG-E-98-C1

  Catheter, Septostomy
  1 report
• NRG Transseptal Needle NRG-71-C0

  Catheter, Septostomy
  1 death1 report
• NRG Transseptal Needle NRG-HF-98-C1

  Catheter, Septostomy
  1 report
• NRG Transseptal Needle NRG-E-HF-98-C0

  Catheter, Septostomy
  1 report
• NRG Transseptal Needle NRG-E-HF-98-C1

  Catheter, Septostomy
  1 report

Recent NRG Transseptal Needle adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

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

  It was reported that a patient experienced ST segment elevation and hypotension during a procedure. They received oxygen, vasopressors, and pacing resolving the issue and allowing the procedure to be completed without further complications.A FARAPULSE procedure to treat paroxysmal atrial fibrillation was performed. An NRG Transseptal Needle was selected for use. After the transseptal access was achieved with the needle, a non-Boston Scientific sheath was advanced into the left atrium of the patient. At this time, ST segment elevation was observed on inferior leads II, III, and aVf. Hypotension was also noted. No air was observed in a device or the patient. The patient, under anesthesia, was treated with oxygen, vasopressors, and pacing to increase heart rate. The physician also evaluated the heart using Intracardiac echocardiography (ICE). No effusion or wall motion abnormalities were observed. After a few minutes, the patient condition resolved. The procedure was completed as expected with no further complications and is in stable condition.

  Patient problems: Low Blood Pressure/ Hypotension; Non specific EKG/ECG Changes

  MAUDE report 50127706 ↗
• DeathJan 27, 2026Adverse Event Without Identified Device or Use Problem

  A CARDIAC ARREST OCCURRED AND THE PATIENT PASSED AWAY. IT WAS REPORTED THAT AN NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE DURING A CONCOMITANT PULSED FIELD ABLATION (PFA) AND THEN WATCHMAN PROCEDURE TO TREAT ATRIAL FIBRILLATION (AFIB). FOLLOWING COMPLETION OF THE PROCEDURE, ALL PRODUCTS WERE REMOVED FROM THE PATIENT. A NON-BOSTON SCIENTIFIC DEVICE WAS REQUESTED AND THE PATIENT WAS PREPARED FOR THE USE OF IT. ONCE TRANSSEPTAL WAS ACHIEVED, A NON-BOSTON SCIENTIFIC SHEATH WAS EXCHANGED FOR A NON-BOSTON SCIENTIFIC DELIVERY SHEATH. A NON-BOSTON SCIENTIFIC PIGTAIL CATHETER WAS INSERTED, AND THE PATIENT BLOOD PRESSURE DROPPED. A CARDIAC ARREST WAS REPORTED. A CARDIOPULMONARY RESUSCITATION (CPR) WAS ADMINISTRATED WHEN PACING COULD NOT BE CAPTURED. AFTER SEVERAL MINUTES OF ATTEMPTED TO STABILIZE THE PATIENT, A CORONARY ANGIOGRAPHY WAS PERFORMED. A NON-BOSTON SCIENTIFIC DEVICE WAS PLACED INTO THE PATIENT. THE PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND THE STANDARD COURSE OF CARE. THE WATCHMAN PROCEDURE WAS ABORTED. THE NRG NEEDLE WAS NOT IN THE BODY AT THE TIME OF THE ISSUE HAPPENED, AND ACCORDING TO THE PHYSICIAN, THE DEVICE DID NOT CONTRIBUTE TO THE EVENT. LATER, IT WAS REPORTED THAT THE

  Patient problems: Cardiac Arrest; Low Blood Pressure/ Hypotension

  MAUDE report 24193445 ↗
• MalfunctionNov 6, 2025Use of Device Problem; Difficult to Advance; Use of Device Problem; Difficult to Advance

  IT WAS REPORTED THAT NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE. IT WAS MENTIONED THAT IT WAS DIFFICULT TO CROSS THE SEPTUM USING NRG NEEDLE. THUS, THE CABLE WAS FIRST REPLACED AND ANOTHER ATTEMPT WAS MADE TO STILL NOT ABLE TO CROSS. DUE TO DIFFICULT ANATOMY, IT WAS DIFFICULT TO GET GOOD TENTING SPOT. THE PHYSICIAN DID NOT WANT TO REPLACED THE NEEDLE, SO AS PER THE PHYSICIAN REQUEST, THE NURSE SCRAPE OFF THE INSULATION AT THE PROXIMAL END OF THE NEEDLE, CONNECTED CAUTERY TO IT AND WAS ABLE TO CROSS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME NEEDLE. NO PATIENT COMPLICATIONS WAS REPORTED. THE NEEDLE IS NOT EXPECTED TO BE RETURN AS DISPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23488324 ↗
• InjuryAug 1, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A PERICARDIAL EFFUSION (PE) OCCURRED. DURING A FARAPULSE ABLATION OF ATRIAL FIBRILLATION PROCEDURE, A NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE. THE PHYSICIAN ATTEMPTED TO PERFORM THE TRANSSEPTAL PUNCTURE (TSP) WITH THE FARADRIVE AND THE NRG NEEDLE. AFTER TENTING THE NEEDLE, THE PHYSICIAN KEPT MOVING THE NEEDLE INSIDE THE PATIENT. AFTER A FEW POSITIONING IN THE LEFT ATRIUM, IT WAS NOTED THAT SOME OF THE CONTRAST WAS OUTSIDE OF THE HEART SILHOUETTE. THE SYSTEM WAS WITHDRAWN AND PERFORMED THE TRANSSEPTAL WITH A NON-BOSTON SCIENTIFIC TRANSSEPTAL DEVICE. AFTER THE PROCEDURE, THE ECHO PHYSICIAN CONFIRMED A DISCREET PERICARDIAL EFFUSION. THE EFFUSION WAS DRAINED IT AND THE PATIENT HAD NO OTHER PROBLEM. THE PATIENT WAS FULLY RECOVERED. IN THE PHYSICIAN'S OPINION, THE NRG NEEDLE DID NOT CONTRIBUTE TO THE EVENT, IT WAS THE FARADRIVE DILATOR THAT MAY HAVE CONTRIBUTED TO IT. THE PATIENT HAS A RELATIVE SMALL RIGHT ATRIUM AND MOVING IT TRYING TO POSITION THE SHEATH IN THE FOSSA WAS THE MAIN CAUSE. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). IT WAS FURTHER CONFIRMED THAT THE PATIENT HAS BEEN DISCHARGED IN THE NEXT DAY AFTER FULL EP PROCEDURE PROTOCOL

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 22688662 ↗
• InjuryJul 30, 2025Display or Visual Feedback Problem; Device Sensing Problem; Display or Visual Feedback Problem; Device Sensing Problem

  IT WAS REPORTED THAT A PERICARDIAL EFFUSION (PE) AND CARDIAC TAMPONADE OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A PULMONARY VEIN ISOLATION PROCEDURE, A NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE. THE PHYSICIAN PERFORMED TRANSSEPTAL USING NRG NEEDLE. THE EP MENTIONED THAT IT WAS HARD TO SEE TENTING. AFTER THE TRANSSEPTAL, THE ELECTROPHYSIOLOGIST (EP) BEGAN MAPPING WITH A NON-BOSTON SCIENTIFIC MAPPING CATHETER. AFTER THE MAP HAS BEEN CREATED, THE MAPPING CATHETER WAS WITHDRAWN AND THE FARADRIVE SHEATH WAS INSERTED FOLLOWED BY FARAWAVE CATHETER. THE PHYSICIAN WAS HAVING DIFFICULTIES MANEUVERING THE SHEATH BUT THE PATIENT ALSO HAD AN ATYPICAL ANATOMY WITH A VERY DILATED ATRIUM. AFTER THE LEFT VEINS WERE ABLATED, WHILE THE EP STARTED MOVING THE CATHETER TO THE RIGHT VEINS, THE ANESTHESIA NOTED THAT THE PRESSURE DROPPED FROM ABOUT 160 TO 60 MMHG SYSTOLIC. THE EP USED ULTRASOUND AND CONFIRMED PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED WHICH CONTINUED FOR ABOUT TWO HOURS BEFORE THE PATIENT COULD BE TRANSFER TO AN AVAILABLE OPERATING ROOM FOR A STERNOTOMY. WHEN A STERNOTOMY WAS DONE, THE SURGEON NOTICED THAT IT WAS THE BASE OF THE LAA THAT HAD BEEN LACERATED, WHICH WAS W

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

  MAUDE report 22668171 ↗
• InjuryJul 14, 2025Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD EXPERIENCED AN ANGINA, HYPOTENSION AND PERICARDIAL EFFUSION (PE) POST PROCEDURE. DURING A PULSE FIELD ABLATION PULMONARY VEIN ISOLATION PROCEDURE, A NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS STABLE IMMEDIATELY POST PROCEDURE. SHORTLY AFTER IN RECOVERY, THE PATIENT COMPLAINED OF ANGINA. THE PHYSICIAN SUSPECTED POSSIBLE CORONARY VASOSPASM AND TREATED FOR THAT. AROUND FIVE (5) HOURS LATER, THE PATIENT BECAME HYPOTENSIVE (SYSTOLIC 70S), AND INCREASING ANGINA RADIATING TO JAW. THE PHYSICIAN SAW THE PATIENT IN SHORT STAY, PERFORMED AN ECHO AND FOUND A SMALL EFFUSION. CHEST DRAIN WAS INSERTED AND PATIENT WAS STABILIZED AFTER THAT. THE PHYSICIAN INITIALLY THOUGHT IT COULD HAVE BEEN DURING TRANSSEPTAL PUNCTURE. THE NRG NEEDLE WAS USED TO CROSS MECHANICALLY INSTEAD OF RADIO FREQUENCY APPLICATION. HOWEVER AFTER EVALUATING THE PATIENT, THE EFFUSION WAS ON THE RIGHT SIDE OF THE HEART. THUS, THE PHYSICIAN SUSPECTS DURING VASCULAR ACCESS, THE NON-BOSTON SCIENTIFIC (SL1) SHEATH USED MAY HAVE SCRAPED THE WALL OF THE RIGHT ATRIUM. THE PATIENT STAYED IN CRITICAL CARE UNIT OVERNIGHT, AND WAS DISCHARGED THE NEXT DAY. PHYSICIAN NOTED THA

  Patient problems: Angina; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 22500848 ↗
• InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERICARDIAL EFFUSION (PE) OCCURRED. DURING THE PREPARATION OF THE PULMONARY VEIN ISOLATION/ WATCHMAN PROCEDURE TO TREAT ATRIAL FIBRILLATION, AN NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE. THE PE OCCURRED ON RIGHT VENTRICLE (RV) BEFORE THE PROCEDURE, BUT THE ANESTHESIA DID NOT OBSERVE IT. PHYSICIAN NOTICED PE DURING TRANSSEPTAL PUNCTURE (TSP). DURING TSP (MID/MID) PHYSICIAN WANTED TO SEE MORE EFFUSION THEREFORE HE STARTED CLEARING IT USING NON-BOSTON SCIENTIFIC ACUNAV CATHETER AND NOTICED CONSIDERABLE PE. A PERICARDIOCENTESIS (TAP) WAS PERFORMED. THE PHYSICIAN PUT AN EXCHANGE WIRE OVER THE LEFT ATRIUM (LA). THE PROCEDURE WAS CANCELLED. THE PATIENT IS EXPECTED TO BE FULLY RECOVERED. THE PRODUCT IS NOT EXPECTED TO BE RETURNED AS IT WAS DISPOSED. IN THE PHYSICIAN'S OPINION, THE DEVICE OR PROCEDURE DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT COMPLICATION.

  Patient problems: Pericardial Effusion

  MAUDE report 22037058 ↗
• InjuryMay 13, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT PERICARDIAL EFFUSION (PE) OCCURRED. DURING A PULMONARY VEIN ISOLATION FOR PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE, A NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE. THE PROCEDURE WAS GUIDED BY USING TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND FLUOROSCOPY. THE TRANSEPTAL PUNCTURE COMPLETED. IT WAS CHALLENGING TO ENGAGE THE FOSSA OVALIS (FO) INITIALLY USING TEE AND FLUORO GUIDANCE. A CONTRAST WAS DONE STAINING PERICARDIUM/SEPTUM. DEVICE WERE PULLED BACK AND REENGAGED FO. A SECOND TRANSSEPTAL ATTEMPT WAS SUCCESSFUL WITH NRG. POST ABLATION (TOTAL APPLICATIONS 43) NOTED SMALL TO MODERATE EFFUSION ON TEE WITHOUT RIGHT VENTRICULAR (RV)/ RIGHT ATRIUM COLLAPSE. PATIENT WAS HEMODYNAMICALLY STABLE. PATIENT WAS DISCHARGED THE SAME DAY FOLLOWING A POST PROCEDURE TRANSTHORACIC ECHO. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). THE SAME NRG WAS USED FOR BOTH TSP. DESPITE THE USE OF TEE, THE HEART AXIS WAS SLIGHTLY OFF MAKING VISUALIZATION OF THE FOSSA DIFFICULT. THE FOSSA WAS DIFFICULT TO ENGAGE WHEN THE NEEDLE DROPPED DOWN. ADDITIONAL HEPARIN BOLUS ONLY GIVEN ONCE NO ACUTE EFFUSION WAS NOTED ON TEE FOLLOWING THE TSP. DYE STAINING ON THE SEPTAL MYOCARDIUM NOT

  Patient problems: Pericardial Effusion

  MAUDE report 22012269 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED HYPOTENSION. THE PROCEDURE WAS CANCELLED. DURING A PULSE FIELD ABLATION PROCEDURE, A NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE. THE PHYSICIAN PERFORMED TRANSSEPTAL PUNCTURE (TSP). SHORTLY AFTER THE TSP AND PRIOR TO INSERTION OF THE FARADRIVE, THERE WAS A SUDDEN DROP IN THE BLOOD PRESSURE. THE PHYSICIAN DID NOT SEE AN EFFUSION, AND NOTED NORMAL LEFT ATRIUM PRESSURES AFTER CROSSING. THE CASE WAS ABORTED DUE TO A SUDDEN DROP IN THE PATIENT'S BLOOD PRESSURE AND THE PATIENT WAS SENT FOR A CHEST COMPUTED TOMOGRAPHY (CT) SCAN. THE PATIENT WAS DISCHARGED ON (B)(6) 2025. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). CT INITIALLY SHOWED CONSOLIDATION OF THE LEFT LUNG. HYPOTENSION WAS TREATED WITH CALCIUM, ADRENALINE, PHENYLEPHRINE, VASOPRESSIN, SODIUM BICARBONATE. THE PATIENT HAS HAD A PREVIOUS ATTEMPT AT ABLATION AND HAD THE SAME RESPONSE FOLLOWING TRANSSEPTAL. THE PHYSICIAN BELIEVES THIS IS RELATED TO THE PROCEDURE, BUT NOT TO THE NRG NEEDLE PRODUCT.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 21977565 ↗
• MalfunctionMay 7, 2025Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR SUPRAVENTRICULAR TACHYCARDIA (SVT) ABLATION PROCEDURE. DURING PREPARATION, IT WAS MENTIONED THAT WHEN ATTEMPT WAS MADE TO INSERT THE NRG NEEDLE INTO THE SHEATH, THE TIP OF THE NEEDLE GOT BENT, WHEN THE PHYSICIAN MADE AN ATTEMPT TO RESHAPE BACK TO C1, THE TIP OF THE NEEDLE BROKE OFF WITHOUT ANY FORCE APPLIED. THUS, THE NEEDLE WAS REPLACED WITH SAME MODEL NEEDLE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURN FOR ANALYSIS (DISPOSED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21977561 ↗
• InjuryApr 2, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED PATIENT EXPERIENCED PERICARDIAL AFFUSION AND CARDIAC TAMPONADE. DURING A CONCOMITANT PULSE FIELD ABLATION (PFA) AND WATCHMAN PROCEDURE, A NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE. THE PATIENT HAD COMPLICATED ANATOMY DUE TO KYPHOSIS. THE PHYSICIAN HAD DIFFICULTY PERFORMING TRANSEPTAL PUNCTURE DUE TO ANATOMY. POST TRANSSEPTAL, THE PATIENT MAINTAINED BASELINE HEMODYNAMICS. A NON-BOSTON SCIENTIFIC PFA CATHETER INSERTED, AND ABLATION WAS PERFORMED. UPON REMOVAL OF ABLATION CATHETER, IMAGING PHYSICIAN NOTICED A MODERATE SIZED EFFUSION ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). A WATCHMAN DEVICE DEPLOYED SUCCESSFULLY. A PERICARDIOCENTESIS WAS PERFORMED POST SUCCESSFUL IMPLANT. LATER, THE PATIENT UNDERWENT SURGERY AND WAS HOSPITALIZED AND DISCHARGED ON (B)(6) 2025. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). THE PHYSICIAN BELIEVES THAT MAYBE THE EVENT OCCURRED WHILE TRYING TO GAIN TRANSEPTAL ACCESS.

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 21753457 ↗
• MalfunctionMar 18, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR PULMONARY VEIN ISOLATION. DURING TRANSSEPTAL PUNCTURE, THE PHYSICIAN WAS ABLE TO CROSS THE SEPTUM WITH THE NRG NEEDLE, BUT IT WAS REPORTED THAT THE NRG NEEDLE DID NOT RESPOND AS NORMAL, AND IT SEEMED THAT THE RADIO FREQUENCY (RF) WAS NOT DELIVERED. NO ERROR CODE WAS REPORTED. THE DEVICE WAS RECONNECTED STILL THE ISSUE PERSISTED. EXTRA FORCE WAS NEEDED TO CROSS THE SEPTUM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATION WAS REPORTED. THE NEEDLE HAS RETURNED FOR ANALYSIS AND THE INVESTIGATION IS STILL IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21632507 ↗
• MalfunctionMar 13, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT A NRF TRANSSEPTAL NEEDLE WAS SELECTED FOR USE. DURING THE PROCEDURE, SEVERAL ATTEMPTS TO PERFORM THE TRANSSEPTAL PUNCTURE WERE ATTEMPTED, WITHOUT SUCCESS. STEADY FORWARD PRESSURE AFTER THE ENERGY ATTEMPTS MOVED THE NRG NEEDLE FORWARD INTO THE LEFT ATRIUM (LA). NO PATIENT COMPLICATIONS WERE REPORTED. NO PROCEDURE OUTCOME WAS DISCLOSED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21599786 ↗
• MalfunctionMar 13, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED A NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS MENTIONED THAT IT WAS NOT POSSIBLE TO CROSS THE SEPTUM. A FIRST NRG NEEDLE WAS ADVANCED INTO THE RIGHT ATRIUM (RA) THROUGH A NON-BOSTON SCIENTIFIC SR0 SHEATH, SEVERAL APPLICATIONS OF ENERGY WERE DELIVERED WITHOUT TRANSEPTAL ACCESS. HENCE, A SECOND NRG NEEDLE WAS THEN OPENED AND ADVANCED THROUGH THE SR0. THE SECOND NEEDLE WAS PLACED ON THE SEPTUM AND SEVERAL ATTEMPTS WERE MADE TO DELIVER ENERGY WITHOUT SUCCESS. RESTARTING THE BMC RF GENERATOR AND REPLACING THE GROUNDING PAD AND CABLE WERE ALSO TRIED AND NO IMPROVEMENT. EVENTUALLY A TRICKLE OF SALINE WAS NOTICED IN THE LEFT ATRIUM WAS NOTED ON INTRA CARDIAC ECHO. THE NRG NEEDLE WAS THEN REMOVED, AND A WIRE WAS INSERTED AND CROSSED THE SEPTUM. THE SR0 WAS ADVANCED OVER THE WIRE AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATION WAS REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). NO OTHER ISSUES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21599243 ↗
• MalfunctionMar 13, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED A NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS MENTIONED THAT IT WAS NOT POSSIBLE TO CROSS THE SEPTUM. A FIRST NRG NEEDLE WAS ADVANCED INTO THE RIGHT ATRIUM (RA) THROUGH A NON-BOSTON SCIENTIFIC SR0 SHEATH, SEVERAL APPLICATIONS OF ENERGY WERE DELIVERED WITHOUT TRANSEPTAL ACCESS. HENCE, A SECOND NRG NEEDLE WAS THEN OPENED AND ADVANCED THROUGH THE SR0. THE SECOND NEEDLE WAS PLACED ON THE SEPTUM AND SEVERAL ATTEMPTS WERE MADE TO DELIVER ENERGY WITHOUT SUCCESS. RESTARTING THE BMC RF GENERATOR AND REPLACING THE GROUNDING PAD AND CABLE WERE ALSO TRIED AND NO IMPROVEMENT. EVENTUALLY A TRICKLE OF SALINE WAS NOTICED IN THE LEFT ATRIUM WAS NOTED ON INTRA CARDIAC ECHO. THE NRG NEEDLE WAS THEN REMOVED, AND A WIRE WAS INSERTED AND CROSSED THE SEPTUM. THE SR0 WAS ADVANCED OVER THE WIRE AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATION WAS REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). NO OTHER ISSUES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21599240 ↗

Other Baylis Médicale Cie Inc products

• VersaCross Connect LAAC Access Solution10 models · 301 reports
• VersaCross Access Solution19 models · 98 reports · 1 recall
• VersaCross RF Wire2 models · 22 reports