NRG Transseptal Needle NRG-E-HF-71-C1 (UDI 00685447004530)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00685447004530), received between May 26, 2022 and Nov 6, 2025 — classified as 8 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (4 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 AFTER THE MAP HAS BEEN CREATED, THE MAPPING CATHETER WAS WITHDRAWN AND THE FARADRIVE SHEATH WAS INSERTED FOLLOWED BY FARAWAVE CATHETER.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 ↗
• 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 ↗
• 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 ↗
• MalfunctionMar 13, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE IN A PROCEDURE FOR TYPICAL FLUTTER. DURING THE PROCEDURE, WHILE ATTEMPTING TO GO TRANSSEPTAL, THE TRANSSEPTAL PUNCTURE WAS NOT ACHIEVED AND THE NRG RF NEEDLE WAS REMOVED. CONSIDERING IT WAS NOTED AFTER AN EP STUDY THAT THE ARRHYTHMIA WAS NOT COMING FROM THE LEFT SIDE, THUS IT WAS DECIDED TO PERFORM THE OBLATION ON THE RIGHT SIDE. HENCE, THE ARRYTHMIA WAS ABLE TO BE TREATED FROM THE RIGHT SIDE WITHOUT TRANSEPTAL ACCESS. THEREFORE, TRANSEPTAL ACCESS WAS ABORTED. IT WAS ALSO REPORTED THAT EXTRA FORCE WAS APPLIED WHILE ATTEMPTING TO CROSS THE SEPTUM. NO PATIENT COMPLICATIONS WERE REPORTED. THE OUTCOME OF THE PROCEDURE WAS NOT DISCLOSED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21599237 ↗
• InjuryDec 9, 2024Adverse Event Without Identified Device or Use Problem; Positioning Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  IT WAS REPORTED DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE INDICATED FOR A CASE OF NON-VALVULAR ATRIAL FIBRILLATION (NVAF), A NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE. THE PATIENT HAD AN EXISTING ABBOTT ATRIAL-SEPTAL OCCLUDER DEVICE IN INTRA ATRIAL SEPTUM. THE PHYSICIAN USED TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) FOR IMAGING GUIDANCE FOR THE TRANSEPTAL PUNCTURE. USUAL TRANSSEPTAL BICAVAL AND SHORT AXIS VIEWS WERE VISUALIZED ON TEE. WHEN THE RADIO FREQUENCY (RF) GENERATOR WAS TURNED ON AND AFTER THE RF BUTTON WAS PRESSED, BUBBLES WERE IMMEDIATELY SEEN IN THE AORTA. THE PHYSICIAN WITHDREW THE NEEDLE. PATIENT HEMODYNAMICS WERE STABLE WITHOUT CHANGES. A NON-BOSTON SCIENTIFIC INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER WAS INSERTED FOR ADDITIONAL VISUALIZATION OF THE SEPTUM AND AORTA. CARDIAC SURGERY WAS CALLED TO REVIEW THE CASE, AND NO FURTHER INTERVENTIONS WERE PERFORMED. GROIN WAS CLOSED AND PATIENT WAS EXTUBATED AND TRANSFERRED TO CRITICAL CARE UNIT FOR MONITORING OVERNIGHT. THE PROCEDURE WAS NOT COMPLETED AS THE PHYSICIAN DID NOT FEEL COMFORTABLE PROCEEDING AND WANTED MORE INFORMATION FROM CARDIAC SURGEON PRIOR TO PROCEEDING. PATIENT WAS IN CCU FOR OBSERVATION ONLY.

  Patient problems: Air Embolism; Hematoma; No Clinical Signs, Symptoms or Conditions; Perforation of Vessels

  MAUDE report 20887063 ↗
• InjuryDec 3, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED A PERICARDIAL EFFUSION (PE) LEADING TO CARDIAC TAMPONADE OCCURRED. THE PROCEDURE WAS CANCELLED. IT WAS REPORTED DURING A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, TWO NRG TRANSSEPTAL NEEDLES AND A VERSACROSS CONNECT FOR LAAC KIT WAS SELECTED FOR USE. DURING TRANSEPTAL, THE PHYSICIAN STRUGGLED TO VISUALIZE A TENT ON THE FOSSA. THE FIRST ATTEMPT WAS WITH THE VERSACROSS CONNECT SYSTEM BUT WAS UNSUCCESSFUL. THEN, THE PHYSICIAN SWITCHED TO A NON-BOSTON SCIENTIFIC (SL0) SHEATH WITH NRG NEEDLE BUT IT WAS UNSUCCESSFUL AGAIN. A THIRD ATTEMPT WAS MADE WITH ANOTHER NON-BOSTON SCIENTIFIC (AGILIS) SHEATH WITH A NEW NRG NEEDLE. AT THIS TIME, AN EFFUSION WAS OBSERVED AROUND THE RIGHT ATRIUM (RA) OR RIGHT VENTRICULAR (RV). THE PHYSICIAN ABORTED THE CASE AND PROCEEDED TO TAP THE PATIENT. A DULL RED COLOR 545ML TOTAL REMOVED BUT 160ML GIVEN BACK TO PATIENT. THE PATIENT WAS HOSPITALIZED FOR THE PROCEDURE AND WAS TO REMAIN OVERNIGHT FOR MONITORING. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). NO PE WAS NOTED PRIOR TO THE PROCEDURE. THE PATIENT WAS NOT UNDER WARFARIN AT THE TIME. ELIQUIS WAS THE PATIENT OAC AND SHE WAS TO BE SWITCHED TO PLAVIX ASA PO

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 20834407 ↗
• MalfunctionApr 16, 2024

  ERROR CODE ON BAYLISS GENERATOR, (A015), CHANGED CABLES AND STILL DID NOT WORK. BAD NEEDLE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19114954 ↗
• InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A BLOOD CLOT WAS REPORTED DURING A PROCEDURE WHERE THE NRG TRANSSEPTAL NEEDLE WAS USED. THE BLOOD CLOT WAS OBSERVED ON THE NRG TRANSEPTAL NEEDLE IN THE RIGHT ATRIUM PRIOR TO TRANSSEPTAL PUNCTURE. THE NRG TRANSSEPTAL NEEDLE WAS REMOVED FROM THE BODY AND FLUSHED. ADDITIONAL HEPARIN WAS ADMINISTERED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. AS BAYLIS MEDICAL DEVICES WERE REPORTED TO BE AMONG THE DEVICES USED IN THE PROCEDURE, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15652295 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CASE OF BRADYCARDIA REQUIRING INTERVENTION WAS REPORTED DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE WHERE THE NRG TRANSSEPTAL NEEDLE (BAYLIS MEDICAL COMPANY) WAS USED WITH AN SL1 SHEATH (ST. JUDE MEDICAL) FOR INITIAL TRANSSEPTAL PUNCTURE. TRANSSEPTAL ACCESS WAS INITIALLY ATTEMPTED USING THE VERSACROSS TRANSSEPTAL SHEATH AND VERSACROSS RF WIRE (BAYLIS MEDICAL COMPANY). HOWEVER, THE DEVICES COULD NOT BE SUCCESSFULLY POSITIONED DUE TO COMPLEX PATIENT ANATOMY. THE PHYSICIAN EXCHANGED THE VERSACROSS DEVICES WITH A NRG TRANSSEPTAL NEEDLE AND A SL1 SHEATH. THE PHYSICIAN CONTINUED TO EXPERIENCE DIFFICULTY POSITIONING THE SL1 SHEATH AND THE NRG TRANSSEPTAL NEEDLE. WHILE THE DEVICES WERE BEING MANEUVERED, THE SHEATH MADE CONTACT WITH THE AV NODE RESULTING IN BRADYCARDIA. THE PROCEDURE WAS ABORTED AND A TEMPORARY PACEMAKER WAS INSERTED INTO THE PATIENT. THE PATIENT WAS TRANSFERRED TO THE ICU FOR MONITORING AND RECOVERY. THE PATIENT'S HEART RHYTHM RETURNED TO NORMAL AND THE TEMPORARY PACEMAKER WAS LATER REMOVED. THERE IS NO REASONABLE EVIDENCE TO SUGGEST THAT A BAYLIS MEDICAL DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. HOWEVER, AS BAYLIS MEDICAL DEVICE WAS REPORTED TO

  Patient problems: Bradycardia

  MAUDE report 14504421 ↗