BRK-1™ G407209Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 05414734205184), received between Jul 10, 2018 and Aug 3, 2026 — classified as 4 deaths, 38 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50118948 ↗
• InjuryJun 12, 2026Adverse Event Without Identified Device or Use Problem

  FOLLOWING COMPLETION OF A PVI PROCEDURE, A FOLLOW-UP EXAMINATION WAS PERFORMED, AND AN ULTRASOUND REVEALED A SMALL EFFUSION OVER THE RIGHT ATRIUM. THE PATIENT WAS MONITORED WITH NO ADDITIONAL INTERVENTION ADMINISTERED. IT WAS NOTED THAT THE TRANSSEPTAL PUNCTURE WAS DIFFICULT AND THE PATIENT HAD ABNORMAL CARDIAC ANATOMY. THE PATIENT IS STABLE. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 25487576 ↗
• MalfunctionMay 5, 2026Difficult to Insert

  DURING AN ATRIAL FIBRILLATION PFA PROCEDURE, THERE WAS A DELAY OF PROCEDURE WHEN THE SHEATH AND THE NEEDLE WERE PREPARED FOR TRANSSEPTAL PUNCTURE. AN OBSTRUCTION WAS NOTED WITHIN THE SHEATH AS THE NEEDLE COULD NOT BE INSERTED THROUGH THE DILATOR. THE SHEATH, DILATOR, AND THE NEEDLE WAS EXCHANGED, AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT HEALTH CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25089277 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  AFTER AN OPAL NON-ABBOTT (FARAPULSE PFA BY BOSTON SCIENTIFIC) PROCEDURE, THE CATHETERS WERE TO BE REMOVED WHEN THE PATIENT'S HEART RATE INCREASED AND THE BLOOD PRESSURE DECREASED. AN EFFUSION WAS OBSERVED. A PERICARDIOCENTESIS WAS PERFORMED AND APPROXIMATELY 60 ML OF FLUID WAS REMOVED. A TRANSESOPHAGEAL ECHOCARDIOGRAM WAS USED FOR THE WHOLE PROCEDURE. THE CAUSE OF THE EFFUSION WAS BELIEVED TO BE A FLAP OF TISSUE WHICH WAS PRESENT AT THE FOSSA WHEN PERFORMING THE TRANSSEPTAL PUNCTURE. DUE TO CHALLENGING PATIENT ANATOMY, THE PHYSICIAN REPLACED THE SL0 SHEATH DURING THE TRANSEPTAL PUNCTURE TO BE SURE THE ISSUE WAS NOT RELATED TO THE SHEATH, WHICH IT WAS NOT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 24819096 ↗
• DeathApr 1, 2026Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION (PVI), THE NON-ABBOTT CATHETER (FARAPULSE BY BOSTON SCIENTIFIC) WAS WITHDRAWN BACK INTO THE RIGHT ATRIUM. THE PERICARDIUM WAS PUNCTURED AND BLOOD WAS WITHDRAWN FROM THE PERICARDIAL SAC. WHEN THE BLOOD PRESSURE DID NOT STABILIZE, CHEST COMPRESSIONS WERE INITIATED. ANTICOAGULANTS WERE ADMINISTERED. THE PATIENT EXPERIENCED ASYSTOLE FOLLOWED BY A DROP IN BLOOD PRESSURE. AN ULTRASOUND WAS PERFORMED, REVEALING A PERICARDIAL TAMPONADE. A PERICARDIOCENTESIS WAS THEN PERFORMED. THE BLOOD PRESSURE DID NOT STABILIZE. RESUSCITATION EFFORTS CONTINUED BUT WERE UNSUCCESSFUL. THE PATIENT DIED ON THE OPERATING TABLE. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE. THE PHYSICIAN THINKS THE PERFORATION POSSIBLE OCCURRED AFTER THE FIRST ENERGY RELEASE.

  Patient problems: Asystole; Cardiac Perforation

  MAUDE report 24753092 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  DURING THE ATRIAL FIBRILLATION PROCEDURE, THE AORTA WAS PUNCTURED WITH THE NEEDLE. WHEN ATTEMPTING TO PERFORM TRANSSEPTAL PUNCTURE WITH THE NEEDLE, THE NEEDLE MOVED TO THE OTHER SIDE AND THE AORTA WAS PUNCTURED. THE PROCEDURE WAS STOPPED AND INTERVENTION WAS PERFORMED. THE PATIENT WAS NOT STABLE WHEN LEAVING THE HOSPITAL AND WAS ON THE WAY TO ANOTHER HOSPITAL FOR AN EMERGENCY OPERATION. THE PATIENT HAD HEART SURGERY BEFORE, SO THE ANATOMY WAS DIFFERENT THAN THE PHYSICIAN EXPECTED. THERE WERE NO PERFORMANCE ISSUES NOTED WITH ANY ABBOTT DEVICE.

  Patient problems: Great Vessel Perforation

  MAUDE report 24743552 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PFA PROCEDURE, FOLLOWING THE TRANSESOPHAGEAL ECHO GUIDED TRANSEPTAL, A PERICARDIAL EFFUSION WAS DIAGNOSED WITH TRANSESOPHAGEAL ECHOCARDIOGRAM. HEPARIN REVERSAL WAS ADMINISTERED. THE PATIENT IS STABLE. THE PHYSICIAN ALLEGES THE TRANSSEPTAL PUNCTURE BEING TOO POSTERIOR AS THE CAUSE FOR THE PERICARDIAL EFFUSION. THERE WERE NO ISSUES NOTED DURING THE TRANSSEPTAL PUNCTURE. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 23989255 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE PROCEDURE, A PERICARDIAL EFFUSION/TAMPONADE WAS NOTED, RESULTING IN A PERICARDIOCENTESIS. POST TRANSSEPTAL PUNCTURE, THE NON-ABBOTT CATHETER (QDOT) WAS ADVANCED INTO THE PERICARDIAL SPACE. THERE WAS RESTRICTED MOVEMENT, SO THE CATHETER REMOVED. A PERICARDIOCENTESIS WAS PERFORMED AND THE PROCEDURE WAS ABANDONED. THE PATIENT WAS TRANSFERRED TO THE ICU FOR MONITORING. THE PHYSICIAN ALLEGES THE TRANSSEPTAL PUNCTURE NEEDLE TO BE THE CAUSE.

  Patient problems: Cardiac Perforation

  MAUDE report 23786595 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PFA PROCEDURE, THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION WHICH REQUIRED A PERICARDIOCENTESIS. THE ACCESS TO THE LEFT ATRIUM WAS COMPLEX AND REQUIRED REPEATED ATTEMPTS DUE TO PATIENT ANATOMY. THE SL1 WAS USED WITH THE BRK FOR THE TRANSSEPTAL PUNCTURE WHICH REQUIRED MULTIPLE ATTEMPTS. THE SL1 WAS REPLACED BY THE AGILIS 13F WHICH WAS DIFFICULT TO ADVANCE. AFTER MULTIPLE INSERTION ATTEMPTS, THE DILATOR WAS OBSERVED TO BE BENT. THE AGILIS 13F WAS CHANGED TO A NON-ABBOTT SHEATH (FARADRIVE BY BOSTON SCIENTIFIC). PFA WAS SUCCESSFUL USING THE NON-ABBOTT CATHETER (FARAWAVE BY BOSTON SCIENTIFIC). APPROXIMATELY 45 MINUTES POST-PROCEDURE, WHILE IN THE RECOVERY AREA, THE PATIENT BECAME HYPOTENSIVE AND REPORTED SHORTNESS OF BREATH AND DIZZINESS. A TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED WHICH REVEALED A MODERATE PERICARDIAL EFFUSION COMPARED TO THE PRE-PROCEDURE TTE WHICH HAD SHOWN A SMALL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THE PHYSICIAN ALLEGES THE LEFT ATRIUM POSTERIOR WALL WAS ACCIDENTALLY PERFORATED BY THE BRK NEEDLE AS IT WAS NOTED THE TRANSSEPTAL CROSSING WAS DIFFICULT DUE TO CHALLENGING PATIENT ANATOMY AND REQU

  Patient problems: Cardiac Perforation

  MAUDE report 23551293 ↗
• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING EVENT WAS RECEIVED FROM A VOLUNTARY MEDWATCH REPORT: DURING AN ATYPICAL FLUTTER PROCEDURE, A CARDIAC PERFORATION OCCURRED WHICH DID NOT REQUIRE ANY INTERVENTION. THE RIGHT ATRIAL MAP WAS PERFORMED WITH A NON-ABBOTT CATHETER (OCTARAY BY JOHNSON AND JOHNSON). TRANSSEPTAL PUNCTURE WAS DONE TO ACCESS THE LEFT ATRIUM. THE PHYSICIAN NOTICED SHE PUNCTURED THE SEPTUM AND GOT INTO THE PERICARDIUM. THE PATIENT BLOOD PRESSURE WAS STABLE. THE SHEATH WAS RETRIEVED AND THE TRANSSEPTAL PUNCTURE WAS PERFORMED AGAIN. THE LEFT ATRIAL MAP WAS PERFORMED WITH THE NON-ABBOTT CATHETER (OCTARAY BY JOHNSON AND JOHNSON). ABLATION WAS DONE WITH THE NON-ABBOTT CATHETER (SMARTTOUCH SURROUND FLOW BY JOHNSON AND JOHNSON). THE PROCEDURE FINISHED SUCCESSFULLY. LATER IN THE DAY, AN ECHOCARDIOGRAM WAS PERFORMED, AND NO TAMPONADE WAS FOUND. THE PATIENT WAS STABLE. THE NEXT DAY THE PATIENT WAS STILL STABLE WITH NO SYMPTOMS RELATED TO THE EVENT. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

  Patient problems: Cardiac Perforation

  MAUDE report 23479996 ↗
• InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN IMPLANT PROCEDURE, A PERICARDIAL EFFUSION OCCURRED REQUIRING SURGICAL INTERVENTION. FOLLOWING TRANSSEPTAL PUNCTURE, DURING DEVICE DEPLOYMENT, THE PATIENT BECAME HYPOTENSIVE. ECHOCARDIOGRAPHIC IMAGING REVEALED THE PRESENCE OF A PERICARDIAL EFFUSION. THE PATIENT REQUIRED EVALUATION AND MANAGEMENT BY THE CARDIOVASCULAR SURGERY TEAM, WHO IDENTIFIED AN INJURY AT THE LEFT ATRIOVENTRICULAR JUNCTION. THE PERICARDIAL EFFUSION WAS SUCCESSFULLY MANAGED, AND THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) FOR CLOSE MONITORING AND FURTHER CARE. THE PATIENT REMAINS HEMODYNAMICALLY STABLE, WITH NO EVIDENCE OF ACTIVE BLEEDING. THE PATIENT HAS SINCE RECOVERED AND WAS DISCHARGED. THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES. THE PHYSICIAN REPORTED CHALLENGES DURING THE TRANSSEPTAL PUNCTURE DUE TO SUBOPTIMAL IMAGE QUALITY OF THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND TO THE PATIENT'S ANATOMICAL CHARACTERISTICS.

  Patient problems: Cardiac Perforation

  MAUDE report 23420657 ↗
• MalfunctionJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE, A PERFORATION OCCURRED AROUND THE RIGHT VENTRICLE AND RIGHT ATRIUM WHICH REQUIRED A PERICARDIOCENTESIS TO STABILIZE THE PATIENT. DURING REMOVAL OF THE CATHETERS, THE PATIENTS BLOOD PRESSURE AND CAPNIA DROPPED AFTER INJECTION OF STRYADINE WHEN CHECKING PROPER ISOLATION OF THE PULMONARY VEINS. AN ULTRASOUND WAS PERFORMED WHICH REVEALED A PERFORATION AND A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT.

  Patient problems: Cardiac Perforation

  MAUDE report 22648149 ↗
• InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AF PROCEDURE, THERE WAS DIFFICULTY INSERTING THE ADVISOR MAPPING CATHETER THROUGH SL1 INTO THE LEFT ATRIUM. THE SHEATH WAS EXCHANGED WHICH RESOLVED THE ISSUE. WHILE THE ADVISOR CATHETER AND THE FLEXABILITY WERE IN THE LEFT ATRIUM TO ABLATE, IT WAS NOTED THAT THE PATIENT'S BLOOD PRESSURE DECREASED. ECHO WAS PERFORMED WHICH SHOWED A PERICARDIAL EFFUSION. THE PROCEDURE ENDED AND THE FLUID WAS DRAINED. THE PHYSICIAN ALLEGES THAT THE EFFUSION WAS CAUSED BY THE TRANSEPTAL PUNCTURE AND NOT BY THE CHANGE OF THE SHEATH. THE PATIENT WAS CURRENTLY STABLE.

  Patient problems: Cardiac Perforation

  MAUDE report 21317308 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A MITRACLIP PROCEDURE, A PERICARDIAL EFFUSION OCCURRED WHICH REQUIRED A PERICARDIOCENTESIS TO STABILIZE THE PATIENT. THE TRANSSEPTAL PUNCTURE WAS PERFORMED AND A STEERABLE GUIDE CATHETER (SGC) WAS INSERTED AND ADVANCED TO THE MITRAL VALVE. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED WHICH REVEALED A THROMBUS AND A PERICARDIAL EFFUSION. HEPARIN WAS ADMINISTERED TO TREAT THE THROMBUS. A PERICARDIOCENTESIS WAS PERFORMED TO TREAT THE PERICARDIAL EFFUSION. THE SGC WAS REMOVED, AND THE PROCEDURE WAS DISCONTINUED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENT DOES NOT HAVE A PREEXISTING HISTORY OF THROMBUS AND A PRE-PROCEDURE TEE PERFORMED WAS NEGATIVE. THE PHYSICIAN DOES NOT KNOW WHAT CAUSED THE THROMBUS. THERE WERE REPORTED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation; Thrombosis/Thrombus

  MAUDE report 20776903 ↗
• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER THE CRYO ATRIAL FIBRILLATION PROCEDURE WAS OVER AND THE PATIENT WAS TRANSFERRED TO RECOVERY AREA, A PERICARDIAL EFFUSION WAS NOTED AND A PERICARDIOCENTESIS WAS PERFORMED. IN RECOVERY, THE PATIENT¿S BLOOD PRESSURE DROPPED, AND THE PATIENT WAS BROUGHT BACK TO THE ELECTROPHYSIOLOGY LAB. AN ECHO WAS PERFORMED, AND A MINOR PERICARDIAL EFFUSION WAS NOTED. THE PHYSICIAN WAS ABLE TO PERFORM A PERICARDIOCENTESIS AND THE PATIENT WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION. THE PHYSICIAN DOES NOT KNOW WHAT CAUSED THE EFFUSION OR WHEN THE EFFUSION OCCURRED. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 20237649 ↗
• InjurySep 16, 2024Difficult to Insert; Device Contamination with Body Fluid; Difficult to Insert; Device Contamination with Body Fluid

  RELATED MANUFACTURING REF: 3005334138-2024-00353, 3005334138-2024-00352 DURING AN ATRIAL FIBRILLATION PROCEDURE, THE TRANSSEPTAL NEEDLE WITH STYLET WENT THROUGH THE INTRODUCER DURING TRANSSEPTAL PUNCTURE. THE INTRODUCER WAS EXCHANGED, HOWEVER THE SAME ISSUE OCCURRED. THE PROCEDURE WAS THEN CANCELLED DUE TO A THROMBUS NOTED IN THE LEFT ATRIUM. THE THROMBUS WAS NOT PRESENT PRIOR TO THE PROCEDURE. THE PHYSICIANS CONSIDERED IT A MEDICAL CONDITION OF THE PATIENT. THE PATIENT'S NEUROLOGICAL STATUS WAS CHECKED, AND EVERYTHING WAS STABLE AT THE END OF THE PROCEDURE. PATIENT'S INFORMATION (E.G. AGE, WEIGHT, GENDER, ETHNICITY, RACE, PATIENT'S INITIALS) CANNOT BE HANDLED BY ABBOTT IN ABSENCE OF PATIENT'S WRITTEN CONSENT AS REQUIRED BY THE PERSONAL DATA PROTECTION NATIONAL LEGISLATION. NATIONAL LEGISLATION PREVENTS THE RECORDING OF SUCH INFORMATION. A WRITTEN CONSENT HAS NOT BEEN OBTAINED IN THIS CASE; THEREFORE, THIS INFORMATION IS NOT AVAILABLE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20227014 ↗
• MalfunctionSep 16, 2024Flaked; Flaked

  DURING THE PULMONARY VEIN ISOLATION PROCEDURE, IT WAS NOTED THAT WHILE INSERTING THE NEEDLE INTO THE SHEATH, THE NEEDLE DID NOT GO THROUGH THE SHEATH CLEANLY, AND A "SCRATCHING" FEEL WAS NOTED. THE NEEDLE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20226511 ↗
• InjuryAug 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A REDO MITRACLIP PROCEDURE, A PERICARDIAL EFFUSION OCCURRED ON THE DURING TRANSSEPTAL PUNCTURE REQUIRING A PERICARDIOCENTESIS. THE ORIGINAL MITRACLIP PROCEDURE WAS PERFORMED ON (B)(6) 2024 TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4. ONE CLIP WAS DEPLOYED ON THE MITRAL VALVE, REDUCING THE MR TO A GRADE OF 1. ON (B)(6) 2024, THE MR HAD INCREASED TO A GRADE OF 3. THE IMPLANTED CLIP REMAINED STABLE ON THE LEAFLETS AND THE PHYSICIAN STATED THE RECURRENT MR WAS DUE TO A PROGRESSION OF DISEASE. THE PATIENT UNDERWENT AN ADDITIONAL MITRACLIP PROCEDURE. DURING THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE AND AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION ON THE RIGHT SIDE DUE TO TRANSSEPTAL PUNCTURE. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT AND THE PROCEDURE WAS ABORTED. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 19990131 ↗
• InjuryApr 15, 2024Difficult to Insert; Device Contamination with Body Fluid; Difficult to Insert; Device Contamination with Body Fluid

  DURING A PULMONARY VEIN ISOLATION PROCEDURE, A SMALL BLOOD CLOT WAS NOTED ON THE NEEDLE. TRANSEPTAL PUNCTURE (WITH A STYLET) WAS DIFFICULT AND REQUIRED MULTIPLE ATTEMPTS TO CROSS THE SEPTUM. AFTER ONE OF THE ATTEMPTS, THE NEEDLE WAS REMOVED FROM THE PATIENT AND IT WAS NOTICED THAT THEN NEEDLE COULD NOT BE FLUSHED OR DRAWN BACK. THE PHYSICIAN ASKED FOR ANOTHER NEEDLE AND THE CASE CONTINUED WITHOUT ANY ADVERSE EVENTS. THE ORIGINAL NEEDLE WAS LATER CHECKED OUTSIDE THE PATIENT BY REINSERTING THE DILATOR AND A SMALL BLOOD CLOT WAS PUSHED OUT OF THE NEEDLE AND THE NEEDLE COULD BE FLUSHED EASILY.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19105986 ↗
• MalfunctionMar 20, 2024Gas/Air Leak; Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, AN AIR LEAK OCCURRED. ONCE THE NEEDLE WAS INSERTED INTO THE PATIENT, WHEN ATTEMPTING TO PULL BLOOD BACK, AIR ENTERED THE SYSTEM. IT SEEMED THE THREADING BETWEEN THE FLUSH AND NEEDLE WAS NOT TIGHT. THE NEEDLE WAS REPLACED AND THE PROCEDURE CONTINUED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18940233 ↗
• InjuryFeb 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE PROCEDURE, A TAMPONADE OCCURRED AT THE BEGINNING OF THE PROCEDURE. THE CATHETER WAS IN THE LEFT ATRIUM AT THE TIME AND INQUIRY WAS IN THE CORONARY SINUS. THE PATIENT BECAME HYPOTENSIVE AND AN ULTRASOUND REVEALED AN EFFUSION FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT.

  Patient problems: Cardiac Perforation

  MAUDE report 18666790 ↗
• InjuryOct 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WHILE RECOVERING FROM AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A CARDIAC PERFORATION WAS NOTED. DURING THE PROCEDURE, WHILE ATTEMPTING THE TRANSSEPTAL PUNCTURE, AORTIC PRESSURE WAS RECORDED. THE SHEATH WAS NOT ADVANCED. THE NEEDLE WAS RETRACTED AND A SECOND PASS WAS SUCCESSFUL IN GAINING ACCESS TO THE LEFT ATRIUM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS STABLE THROUGHOUT WITH NO NEGATIVE CONSEQUENCES OBSERVED. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE DURING THE PROCEDURE. THE PHYSICIAN REPORTED THAT LATER THAT NIGHT THE PATIENT EXPERIENCED A TAMPONADE ON THE WARD. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT IS NOW STABLE AND RECOVERING. BASED ON THE LOCATION OF THE TAMPONADE, IT IS SUSPECTED THAT IT OCCURRED DURING THE AORTIC PUNCTURE.

  Patient problems: Cardiac Perforation

  MAUDE report 17977734 ↗
• InjurySep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE PROCEDURE, MAPPING OF THE RIGHT ATRIUM WAS PERFORMED WITH NON ABBOTT MAPPING CATHETERS (J&J PENTARAY, DECANAV AND STSF). THE TRANSEPTAL PHASE WAS THEN STARTED, TRANSSEPTAL PUNCTURE WAS PERFORMED AND THE NON ABBOTT CATHETER (PENTARAY) WAS INTRODUCED. IN THAT MOMENT, THE PHYSICIAN REALIZED THERE WAS A TAMPONADE AND A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT UNDER SUPERVISION.

  Patient problems: Cardiac Perforation

  MAUDE report 17746802 ↗
• InjuryAug 17, 2023Difficult to Insert; Difficult to Insert

  RELATED MANUFACTURING REFERENCE: 3008452825-2023-00359. DURING A VENTRICULAR TACHYCARDIA PROCEDURE, A SMALL PERICARDIAL EFFUSION OCCURRED. NO INTERVENTION WAS REQUIRED BUT THE PROCEDURE WAS CANCELLED. THE PATIENT REMAINED STABLE BUT WAS MONITORED OVERNIGHT IN THE INTENSIVE CARE UNIT. THE FIRST TRANSSEPTAL PUNCTURE WAS UNSUCCESSFUL DUE TO ROTATED HEART. PUNCTURE WAS BELIEVED TO BE IN PERICARDIUM AS EVIDENCED BY NO LEFT ATRIAL PRESSURE NOTED. TRANSESOPHAGEAL ECHOCARDIOGRAM GUIDANCE WAS USED FOR SECOND PUNCTURE ATTEMPT AND THE BRK XS WAS EXCHANGED FOR BRK 1. DURING ECHO, IT WAS NOTED THAT THERE WAS A SMALL EFFUSION. THE PHYSICIAN DECIDED TO CONTINUE THE PROCEDURE AT THIS TIME AS THE EFFUSION WAS SMALL AND STABLE AND THE PATIENT WAS ASYMPTOMATIC. SECOND TRANSEPTAL PUNCTURE WAS ATTEMPTED BUT WAS UNSUCCESSFUL WHICH WAS EVIDENCE BY AORTIC PRESSURES. THE PROCEDURE WAS ABANDONED, AND THE EFFUSION WAS STABLE. THE PHYSICIAN BELIEVES THE EFFUSION MOST LIKELY OCCURRED DURING THE FIRST TRANSEPTAL PUNCTURE WHICH WAS IN THE PERICARDIUM. HOWEVER, HE ABANDONED THE CASE AFTER THE SECOND TRANSEPTAL PUNCTURE WHICH WAS IN THE AORTA. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 17568580 ↗
• InjuryMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION A PERICARDIAL EFFUSION OCCURRED REQUIRING A PERICARDIOCENTESIS. ALL FOUR VEINS WERE SUCCESSFULLY ISOLATED, BUT POST PROCEDURE AN ECHOCARDIOGRAM WAS PERFORMED SHOWING THE PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS DONE AND THEN THE PATIENT WAS TRANSFERRED TO THE ICU. THE PATIENT REMAINED STABLE THROUGHOUT. THE PHYSICIAN SAID NO EQUIPMENT WAS AT FAULT BUT ALLEGES THE PERFORATION TO HAVE BEEN CAUSED BY TRANSEPTAL PUNCTURE.

  Patient problems: Cardiac Perforation

  MAUDE report 16613138 ↗