NRG Transseptal Needle NRG-E-HF-71-C0 (UDI 00685447000204)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00685447000204), received between Oct 3, 2019 and Mar 10, 2026 — classified as 6 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (9 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CARDIAC PERFORATION AND CARDIAC TAMPONADE OCCURRED. DURING A FARAPULSE ATRIAL FIBRILLATION PROCEDURE, A NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE. THE PHYSICIAN WAS INITIALLY AT WRONG POSITION AND HAD TO READJUST THE POSITION AND PERFORMED TRANSSEPTAL PUNCTURE (TSP). THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) CONFIRMED TSP WENT GOOD WITHOUT TAMPONADE. THE PROCEDURE WAS COMPLETED HOWEVER AT THE END, THE PHYSICIAN NOTED IN THE ECHO A LARGE TAMPONADE IN RIGHT VENTRICULAR (RV) WALL. IT WAS NECESSARY TO DRAIN THE BLOOD FROM PERICARDIUM (350 ML). THE PATIENT REMAINED HOSPITALIZED. ACT WAS ABOVE 300. THE PERFORATION WAS CONFIRMED BY TRANSESOPHAGEAL ECHOCARDIOGRAPHY, AND THE SUSPICION IS THAT SOMETHING WENT WRONG DURING THE TRANSSEPTAL PUNCTURE PROCESS. PHYSICIAN TRIED TO DO THE TRANSSEPTAL ACCESS IN TWO PLACES. PHYSICIAN WAS NOT CONFIDENT THAT THE SYSTEM WAS IN A SECURE POSITION. THEREFORE, HE REPOSITIONED THE SYSTEM AFTER THE INITIAL ATTEMPT. AFTER THIS ATTEMPT, CHECKED THE PERICARDIUM USING TRANSESOPHAGEAL ECHOCARDIOGRAPHY, AND THE ECHOCARDIOGRAPHER REPORTED NO ISSUES. CARDIAC TAMPONADE WAS OBSERVED AFTER ALL CATHETERS WERE WITHDRAWN. THE DEVICE IS NOT EXPECTED TO B

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion; Pericarditis

  MAUDE report 24563849 ↗
• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem

  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.

  Patient problems: Hematoma; Low Blood Pressure/ Hypotension; Retroperitoneal Hemorrhage

  MAUDE report 24401789 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  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.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 24216026 ↗
• MalfunctionNov 24, 2025Failure to Deliver Energy; Off-Label Use; Failure to Advance; Failure to Deliver Energy; Off-Label Use; Failure to Advance

  IT WAS REPORTED THAT NRG TRANSSEPTAL NEEDLE SELECTED FOR USE. DURING PROCEDURE, WHEN THE NRG NEEDLE WAS CONNECTED TO THE ELECTRICAL CONSOLE, A GENERIC ERROR MESSAGE APPEARED ON THE SCREEN OF THE BMC RF GENERATOR. AFTER PRESSING 'DISMISS,' THE DISPLAY INDICATED THAT THE PRODUCT WAS 'READY' FOR USE. AFTER THREE ATTEMPTS TO ACTIVATE THE RADIOFREQUENCY WITH THE SAME NEEDLE, THE TRANSSEPTAL PUNCTURE WAS NOT PERFORMED. THE RADIO FREQUENCY WAS DELIVERED THE THREE TIMES, THE SOUND FOR IT WAS HEARD, BUT THE SEPTUM WAS NOT CROSSED. NO ERROR OCCURRED WHEN THE RF ENERGY WAS ACTIVATED. AN ERROR ONLY APPEARED WHEN THE FIRST NEEDLE WAS CONNECTED, THE CABLE WAS NOT REPLACED. THE SEPTUM WAS QUITE FLOPPY. GENERATOR WAS IN READY MODE WHEN THE ISSUE WAS ENCOUNTERED. NO CHALLENGES NOTED RELATED TO THE PATIENT ANATOMY. THERE WAS TENTING OF THE SEPTUM CONFIRMED BEFORE ATTEMPTING TO DELIVER RF ENERGY. THE FIRST NEEDLE WAS MANUALLY RESHAPED PRIOR TO THE PROCEDURE. HENCE, THE DEVICE WAS REPLACED AND THE PROCEDURE PROCEEDED NORMALLY. PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATION WAS REPORTED. THE DEVICE IS NOT EXPECTED TO RETURN FOR ANALYSIS AS DISPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23638650 ↗
• MalfunctionMay 16, 2025Material Deformation; Material Deformation

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 19APR2025 IT WAS REPORTED AN NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE FOR AN ELECTROPHYSIOLOGY PROCEDURE TO TREAT A CASE OF ATRIAL FIBRILLATION (A FIB). HOWEVER, UPON REMOVAL FROM THE PACKAGING IT WAS NOTED THAT THE NEEDLE HAD SIGNS OF DAMAGE/DEFECTIVENESS AND COULD THEREFORE NOT BE USED. THE PROCEDURE WAS INITIALLY HALTED AND EVENTUALLY COMPLETED SUCCESSFULLY USING A DIFFERENT DEVICE (SAME MODEL). NO PATIENT COMPLICATIONS REPORTED. THE PRODUCT HAS RETURNED FOR ANALYSIS. HOWEVER, ANALYSIS REVEALED THAT THE NRG NEEDLE TIP WAS BROKEN AND FULLY DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22037063 ↗
• MalfunctionJun 25, 2024Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT HAS BEEN REPORTED THAT AN NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR A PULSE FIELD ABLATION CASE. DURING THE PROCEDURE, IT WAS MENTIONED THAT WHILE TRYING TO GO TRANSSEPTAL, THE NRG RF NEEDLE WAS UNABLE TO CROSS THE SEPTUM. THREE ATTEMPTS TO DELIVER RADIO FREQUENCY WERE DONE, WITH NO SUCCESS. THEREFORE, THE DEVICE WAS PULLED OUT FOUND TO HAVE ITS TIP BROKEN. THE DEVICE WAS THEN REPLACED, TRANSSEPTAL PUNCTURE WAS ACHIEVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE WILL NOT RETURN FOR ANALYSIS. NO OTHER ISSUES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19608278 ↗
• MalfunctionSep 25, 2023Material Deformation; Material Deformation

  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 DEVICE APPEARED TO HAVE A BURR ON THE TUBE. 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 17809041 ↗
• MalfunctionJun 29, 2023Material Integrity Problem; Material Integrity Problem

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 09JUN2023. IT WAS REPORTED THAT A NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE. DURING A TRANSEPTAL PUNCTURE TO TREAT AN ATRIUM FIBRILLATION, THE NRG NEEDLE WAS NOTED TO BE BENT AT THE TIP, WHEN IT WAS REINSERTED INTO THE DILATOR. A NEW DEVICE WAS INSERTED, AND SEPTAL PUNCTURE WAS PERFORMED WITHOUT ANY PROBLEM. ALSO, ON FLUOROSCOPY, THE TIP FROM THE DILATOR LOOKED DIFFERENT THAN USUAL, SO IT WAS PULLED OUT ONCE, AND CONFIRMED THAT THE TIP WAS BENT. NO PATIENT COMPLICATIONS WERE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. HOWEVER, ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE TIP OF THE NEEDLE WAS BROKEN AND DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17226662 ↗
• MalfunctionJun 28, 2023Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT A NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR TRANSEPTAL ASSESS FOR A CATHETER ABLATION PROCEDURE. RADIO FREQUENCY APPLICATION FOR CROSSING THE SEPTUM WAS PERFORMED FOUR TIMES; HOWEVER, A SEPTAL PUNCTURE WAS UNABLE TO PERFORMED. THEREFORE, A NEW NRG RF NEEDLE WAS OPENED AND THE SEPTAL PUNCTURE WAS ABLE TO PERFORMED WITHOUT ANY PROBLEM. NO PATIENT COMPLICATIONS WERE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS DUE TO INFECTION/CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17218785 ↗
• MalfunctionJun 23, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A BMC NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR TRANSSEPTAL ACCESS. UPON OPENING THE PACKAGE OUTSIDE THE PATIENT PRIOR TO USE A UNSPECIFIED DEFECT WAS IDENTIFIED. HOWEVER, THE PROCEDURE WAS DISCONTINUED. NO PATIENT COMPLICATIONS REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER SEDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17191637 ↗
• InjuryJun 20, 2023Difficult to Advance; Positioning Problem; Physical Resistance/Sticking; Difficult to Advance; Positioning Problem; Physical Resistance/Sticking

  A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A TRANSSEPTAL PUNCTURE (TSP) WAS BEING PERFORMED USING AN NRG (RF) NEEDLE. TRANSSEPTAL POSITION WAS AIMED IN THE INFERIOR/POSTERIOR AND TENTING TO THE POSTERIOR/MID WAS CONFIRMED. WHEN THE RF NEEDLE WAS INSERTED, IT SLIPPED UPWARD, AND THE POSITION SHIFTED (DEVIATING IN THE DIRECTION OF SUPERIOR OUTSIDE FOSSA AND IT IS POSSIBLE THAT AN UNINTENDED LOCATION WAS MECHANICALLY PUNCTURED). ADJUSTMENT WAS PERFORMED AGAIN DOWNWARD, AND ENERGIZATION WAS PERFORMED IN THE MID POSITION, BUT THE NEEDLE DID NOT COME OFF (GOT STUCK DUE TO THE PATIENT ANATOMY), SO ENERGIZATION WAS PERFORMED AGAIN. A WATCHMAN FXD CURVE ACCESS SYSTEM (WAS) WAS ADVANCED AND IT WAS DEPLOYED AND RECAPTURED TWICE. THUS, THE WATCHAN WAS REMOVED SO THAT A NEW TRANSSEPTAL WITH THE SAME NRG RF NEEDLE COULD BE PERFORMED. UPON REMOVAL OF THE DEVICES, A DISSECTION WAS OBSERVED. IT WAS CONFIRMED THAT THERE WAS A PUNCTURE HOLE IN THE ATRIAL SEPTUM SECUNDUM, AND THE DISSECTION OF THE SEPTUM EXTENDED FROM THE PUNCTURE HOLE IN THE ATRIAL SEPTUM SECUNDUM IN A CEPHALIC AND DORSAL DIRECTION. THERE WAS NO ACCUMULATION OF PERICARDIAL EFFUSION. THE PROCEDURE WAS CANCELL

  Patient problems: Perforation of Vessels; Vascular Dissection

  MAUDE report 17162533 ↗
• MalfunctionMay 25, 2023Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT A NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE. DURING AN UNKNOWN PROCEDURE WHILE TRYING TO GO TRANSSEPTAL, THE NRG NEEDLE ENERGIZED, HOWEVER, IT COULD NOT SUCCESSFULLY GO TRANSSEPTAL. NO ISSUES WITH THE BMC GENERATOR WERE REPORTED, SINCE IT WAS WORKING WELL. THE TRANSSEPTAL WAS PERFORMED USING AN NON-BOSTON SCIENTIFIC NEEDLE. NO PATIENT COMPLICATIONS WERE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS AS IT WAS DISPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17003462 ↗
• MalfunctionMay 17, 2023Failure to Advance; Difficult to Advance; Material Deformation; Failure to Advance; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT THE NEEDLE FAILED TO CROSS THE SEPTUM AND HAD A KINK IN THE TIP. DURING A PROCEDURE AN NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE. A FIRST PUNCTURE WAS SUCCESSFUL, BUT THE SHEATH CAME OUT DUE TO AN OPERATION ERROR. ENERGIZATION WAS PERFORMED TWICE ATTEMPTING TO PUNCTURE AGAIN, BUT THE NEEDLE DID NOT CROSS. DURING ENERGIZATION AN ENERGIZATION SOUND WAS HEARD, BUT NO ERROR MESSAGE APPEARED. WHEN THE NEEDLE WAS REMOVED FROM THE SHEATH A KINK IN THE TIP WAS CONFIRMED. THE NEEDLE WAS REPLACED WITH ANOTHER OF THE SAME MODEL AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16947153 ↗
• MalfunctionMay 10, 2023Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE A NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE. AS THE NEEDLE WAS INSIDE THE PATIENT, THE NEEDLE WAS REPORTED TO HAVE FLOW ISSUES FROM THE FLUSHING PORT AS THERE WAS NO CIRCULATING FLOW. IT WAS CONFIRMED THAT THE SYRINGE WAS SECURELY ATTACHED TO THE HANDLE LUER. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEEDLE. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS NOT BEING RETURNED FOR FURTHER ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16903174 ↗
• MalfunctionApr 27, 2023Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A SEPTAL PUNCTURE PROCEDURE AN NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE. ENERGIZATION OF THE NEEDLE WAS ABLE TO BE PERFORMED WITH NO PROBLEMS; HOWEVER, THE SEPTAL PUNCTURE COULD NOT BE PERFORMED. ENERGIZATION WAS PERFORMED THREE TIMES THEREAFTER, BUT THE APPROACH WAS STILL NOT POSSIBLE. IT WAS NOTED THAT THE TIP OF THE NEEDLE FELT STIFFER THAN USUAL AS WELL. THE NEEDLE WAS REPLACED WITH ANOTHER OF THE SAME MODEL. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16825684 ↗
• MalfunctionApr 3, 2023Failure to Advance; Material Integrity Problem; Failure to Advance; Material Integrity Problem

  DURING TRANSSEPTAL PUNCTURE A NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE. AFTER OPENING THE DEVICE AS USUAL, FLUSHING WAS PERFORMED AND THE DEVICE WAS INSERTED INTO THE SHEATH. IT WAS REPORTED THAT ALTHOUGH ENERGIZATION WAS DONE, THE TIP DID NOT PASS THROUGH THE INTERATRIAL SEPTUM, INSERTION WAS REPEATED ABOUT THREE TIMES, BUT IT WAS STILL UNABLE TO CROSS. THE NEEDLE WAS REMOVED AND THE TIP WAS CHECKED, WHICH REVEALED THAT SOME PARTS OF POLYTETRAFLUOROETHYLENE COATING UP TO ABOUT THREE CENTIMETERS FROM THE TIP WERE PEELED OFF. A NEW NEEDLE WAS USED AND CROSSING WAS COMPLETED SUCCESSFULLY WITH ONE ENERGIZATION WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16663526 ↗
• MalfunctionMar 28, 2023Use of Device Problem; Obstruction of Flow; Failure to Advance; Use of Device Problem; Obstruction of Flow; Failure to Advance

  IT WAS REPORTED THAT DURING A PROCEDURE A NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE. DURING THE PROCEDURE THE RF NEEDLE WAS FLUSHED WITH SALINE SOLUTION AND MORE RESISTANCE THAN USUAL WAS FELT, HOWEVER, THE PROCEDURE CONTINUED, AND THE NEEDLE WAS INSERTED INTO THE RIGHT ATRIUM AND ENERGIZATION WAS PERFORMED BUT SEPTAL PUNCTURE COULD NOT BE ACHIEVED. THE RF NEEDLE WAS REMOVED FROM THE SHEATH AND FLUSHED WITH SALINE SOLUTION AGAIN, BUT IT COULD NOT BE FLUSHED. A NEW RF NEEDLE WAS USED AND SEPTAL PUNCTURE WAS PERFORMED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT COMPLICATIONS. THE DEVICE IS EXPECTED TO BE RETURNED FOR LABORATORY ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16628619 ↗
• MalfunctionMar 16, 2023Failure to Advance; Failure to Advance

  DURING TRANSSEPTAL PUNCTURE A NRG TRANSSEPTAL NEEDLE WAS SELECTED FOR USE. IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO PASS THE NEEDLE THROUGH A NON-BOSTON SCIENTIFIC SHEATH TO PERFORM BROCKENBROUGH "BB" METHOD PUNCTURE, BUT IT WAS NOT ABLE TO CROSS; THEREFORE, A NEW NEEDLE WAS USED AND CROSSING WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS. THE DEVICE WAS DISPOSED FOLLOWING THE PROCEDURE. IT WAS FURTHER REPORTED THAT TWO TO THREE ATTEMPTS TO CROSS WERE MADE, HOWEVER, IT WAS UNKNOWN WHY THE NEEDLE WAS UNABLE TO CROSS. THE PATIENT DID NOT HAVE TORTUOUS OR UNUSUAL ANATOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16558100 ↗
• InjurySep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CASE OF HEART BLOCK REQUIRING INTERVENTION DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE WAS REPORTED WHERE THE BAYLIS MEDICAL NRG TRANSSEPTAL KIT WAS USED FOR TRANSSEPTAL PUNCTURE. AS REPORTED, THE RIGHT BUNDLE WAS INADVERTENTLY KNOCKED WHILE MANEUVERING THE TRANSSEPTAL SYSTEM, CAUSING THE PATIENT TO GO INTO HEART BLOCK. CARDIOPULMONARY RESUSCITATION AND EXTERNAL PACING WERE PERFORMED. THE PATIENT WAS STABILIZED AND THE LAAC PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE IS NO REASONABLE EVIDENCE TO SUGGEST THAT THE BAYLIS MEDICAL DEVICES CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. HOWEVER, AS BAYLIS MEDICAL DEVICES WERE REPORTED TO BE AMONG THE DEVICES USED IN THE PROCEDURE, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT. A SEPARATE PROBLEM REPORT HAS BEEN SUBMITTED FOR THE TORFLEX TRANSSEPTAL GUIDING SHEATH WITH THE REPORT NUMBER 3019751610-2022-00028.

  Patient problems: Heart Block

  MAUDE report 15341259 ↗
• MalfunctionApr 21, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE NRG TRANSSEPTAL NEEDLE CAUSED AN ERROR CODE ON THE BAYLIS RADIOFREQUENCY PERFORATION GENERATOR WHEN RF DELIVERY WAS ATTEMPTED, RESULTING IN A 20-MINUTE PROCEDURAL DELAY. THE PROCEDURE WAS CARRIED OUT USING A NEW NRG TRANSSEPTAL NEEDLE. WHILE THERE WAS NO PATIENT INJURY REPORTED, BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT DUE TO THE 20-MINUTE PROCEDURAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11700950 ↗
• InjuryOct 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE NRG TRANSSEPTAL NEEDLE WAS USED IN A LEFT ATRIAL APPENDAGE OCCLUSION (LAAO) PROCEDURE IN WHICH A PERICARDIAL EFFUSION OCCURRED. AN LAAO PROCEDURE WAS PERFORMED AND AT 6:30 AM THE NEXT MORNING, A PERICARDIAL EFFUSION WAS DISCOVERED. THE PATIENT WAS BROUGHT IN TO THE LAB AND PERICARDIOCENTESIS WAS PERFORMED. ASKED FOR A POSSIBLE CAUSE, THE LEAD PHYSICIAN SUSPECTED THAT SINCE IT WAS A VERY SLOW EFFUSION, IT MOST LIKELY OCCURRED DUE TO THE APPENDAGE CLOSURE DEVICE. THE PHYSICIAN RECALLED SOME EXTRA MOVEMENT WHEN TENSION WAS APPLIED TO IT, SO A SMALL TEAR POSSIBLY OCCURRED AT THAT TIME. THERE IS NO EVIDENCE TO SUGGEST THAT A BAYLIS MEDICAL DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. HOWEVER, 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: Pericardial Effusion

  MAUDE report 9182671 ↗
• MalfunctionOct 3, 2019Failure to Deliver Energy; Failure to Deliver Energy

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE PHYSICIAN USED A NRG TRANSSEPTAL NEEDLE TO PERFORM THE TRANSSEPTAL BUT AT THE MOMENT OF APPLYING RADIOFREQUENCY (RF), THE GENERATOR SHOWED A MESSAGE (UNKNOWN CODE) AND DIDN'T APPLY RF. THERE WERE SEVEN ATTEMPTS BUT THE RF DIDN'T OCCUR. A NEW NRG NEEDLE WAS OPENED AND IT WORKED SUCCESSFULLY. BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT DUE TO THE PROCEDURAL DELAY OF 20 MINUTES THAT OCCURRED FOR THIS PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9154270 ↗