BRK™ G407208Recalls & reported problems

Summary

The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 05414734205139), received between Jun 28, 2018 and Aug 12, 2026 — classified as 3 deaths, 65 injuries, 7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 75 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem

  During an atrial fibrillation procedure, a pericardial effusion was noticed after the transesophageal ultrasound. Drainage was not required and ablation was not performed due to the patient's particular anatomy and scoliosis. The pericardial effusion was pre-existing. However, the physician alleges that tenting on the aorta may have caused the pericardial effusion with the BRK needle.

  Patient problems: Cardiac Perforation

  MAUDE report 50228653 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  DURING A LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE, A FEW MINUTES FOLLOWING THE TRANSSEPTAL PUNCTURE, A DROP IN SATURATION WAS OBSERVED AND A TRANSESOPHAGEAL ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED. THE TRANSSEPTAL POSITION WAS ANTERIOR/INFERIOR. THE CAUSE OF THE PERICARDIAL EFFUSION IS UNKNOWN. THE PATIENT IS STABLE. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 25393748 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  DURING A PFA PROCEDURE WITH A VOLT CATHETER, THE PATIENT BECAME HYPOTENSIVE AND ULTRASOUND REVEALED A PERICARDIAL EFFUSION IN THE RIGHT VENTRICLE. A PERICARDIOCENTESIS WAS PERFORMED, HOWEVER THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR SURGERY. THE PHYSICIAN STATED THAT THE EVENT WAS DUE TO A DIFFICULT TRANSSEPTAL PUNCTURE. TRANSSEPTAL WAS PERFORMED WITH A SWARTZ SHEATH AND BRK NEEDLE. DIFFICULTIES WERE EXPERIENCED DUE TO THE PATIENT'S SPECIFIC ANATOMY. THE GUIDE WAS USED TO CHANGE TO AN AGILIS SHEATH BUT TRANSSEPTAL WAS LOST. TRANSSEPTAL PUNCTURE WAS ABOUT TO BE PERFORMED WITH THE AGILIS SHEATH AND A NEW BRK NEEDLE, HOWEVER IT WAS ADVISED TO PERFORM THE PUNCTURE WITH THE SWARTZ SHEATH AND THE BRK NEEDLE INSTEAD. ABLATION STARTED, HOWEVER, THE PERFORATION WAS THEN NOTED AND A PERICARDIOCENTESIS AND SURGICAL INTERVENTION WAS PERFORMED. THE PATIENT IS STABLE AND THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 25273583 ↗
• InjuryJan 19, 2026Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PVI PROCEDURE, THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION WHICH REQUIRED A PERICARDIOCENTESIS. DUAL TRANSEPTAL ACCESS WAS PERFORMED USING ICE IMAGING. THE PATIENT WAS IN SINUS RHYTHM. STANDARD LEFT ATRIAL GEOMETRY AND BASELINE MAPPING WAS PERFORMED. UPON COMPLETION OF MAPPING, A PERICARDIAL EFFUSION WAS NOTED WITH ICE. A PERICARDIOCENTESIS WAS PERFORMED UNDER FLUOROSCOPY. THE PATIENT REMAINED STABLE THROUGHOUT AND WAS TRANSFERRED TO THE WARD WITH NO CHANGE OR INCREASE IN EFFUSION SIZE. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 24108488 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A CARDIAC TAMPONADE OCCURRED REQUIRING A PERICARDIOCENTESIS. TRANSSEPTAL PUNCTURE WAS PERFORMED UNDER ECHOCARDIOGRAPHIC GUIDANCE, SEEMINGLY WITHOUT DIFFICULTY. AN ADVISOR FL MAPPING CATHETER WAS PLACED IN THE LEFT ATRIUM. SHEATH FILTERING ON ENSITE WAS DIFFICULT. GEOMETRY MAPPING BEGAN BUT THE PHYSICIAN HAD SIGNIFICANT DIFFICULTY NAVIGATING WITHIN THE LEFT ATRIUM AND DECIDED TO REPLACE THE CATHETER WITH A TACTICATH SE ABLATION CATHETER. UPON INTRODUCTION OF THE TACTICATH, IMPEDANCE WAS ELEVATED IN CERTAIN AREAS (>300 OHMS) AND THE GEOMETRY DID NOT MATCH THE CT SCAN. THE PATIENT'S BLOOD PRESSURE DROPPED. TRANSTHORACIC ECHOCARDIOGRAPHY REVEALED A SIGNIFICANT PERICARDIAL TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED, THE PATIENT STABILIZED AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. THE PHYSICIAN ALLEGES THE BRK NEEDLE CAUSED OR CONTRIBUTED TO THE TAMPONADE. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 23645247 ↗
• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A REDO ATRIAL FIBRILLATION, WHILE MAPPING WITH THE ADVISOR HD GRID X CATHETER, THE PATIENT DEVELOPED A PERICARDIAL EFFUSION. IT WAS DURING MAPPING THAT THE PATIENT BECAME HYPOTENSIVE. FLUOROSCOPY AND ULTRASOUND SHOWED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. IT IS UNKNOWN WHAT CAUSED THE PERICARDIAL EFFUSION HOWEVER THE PHYSICIAN ALLEGES IT OCCURRED DURING MAPPING OR PRIOR. THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 22805963 ↗
• InjuryJul 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, AN ULTRASOUND REVEALED A PERFORATION. THE PATIENTS BLOOD PRESSURE AND CAPNIA DROPPED AFTER INJECTION OF STRYADINE WHEN CHECKING PROPER ISOLATION OF THE PULMONARY VEINS. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS CONTINUOUSLY MONITORED.

  Patient problems: Cardiac Perforation

  MAUDE report 22648084 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A LEFT PREMATURE VENTRICULAR CONTRACTION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED REQUIRING A PERICARDIOCENTESIS. AFTER TWO ATTEMPTS, THE TRANSSEPTAL PUNCTURE WAS SUCCESSFUL. THE FAST-CATH INTRODUCER WAS THEN CHANGED FOR AN AGILIS STEERABLE INTRODUCER. AFTER INSERTION OF THE ADVISOR HD GRID X CATHETER IN THE LEFT VENTRICLE AND MAPPING WAS STARTED THE PATIENT BECAME HYPOTENSIVE AND BRADYCARDIC, THEN WENT INTO SINUS ARREST, AND THEN HAD JUNCTIONAL RHYTHM. AN ECHOCARDIOGRAM WAS USED TO CONFIRM THE PERICARDIAL EFFUSION. PERICARDIAL PUNCTURE WAS THEN PERFORMED, THE PATIENT STABILIZED, AND THE PROCEDURE WAS STOPPED. THE PHYSICIAN DOES NOT ALLEGE ANY PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Arrhythmia; Cardiac Perforation

  MAUDE report 21878892 ↗
• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED REQUIRING SURGERY TO REPAIR. AT THE BEGINNING OF THE PROCEDURE, THE TRANSSEPTAL PUNCTURE WAS PERFORMED, AND THE MAPPING CATHETER WAS INSERTED INTO THE SHEATH. MAPPING WAS PERFORMED FOR APPROXIMATELY 2 MINUTES WHEN IT WAS NOTED THAT THE CATHETER WAS INTO THE PERICARDIUM. THE PATIENT'S BLOOD PRESSURE THEN DROPPED. AN ULTRASOUND REVEALED A SMALL PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED BUT THE EFFUSION WAS NOT RESOLVED SO THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR SURGERY. THE PHYSICIAN BELIEVES THE TRANSSEPTAL PUNCTURE WAS THE CAUSE FOR THE PERICARDIAL EFFUSION. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 21447932 ↗
• MalfunctionSep 25, 2024Fracture; Fracture

  THIS REPORT IS TO ADVISE OF A NEEDLE FRACTURE NOTED DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20300121 ↗
• DeathSep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REFERENCE: 3005334138-2024-00358. DURING A VENTRICULAR TACHYCARDIA PROCEDURE, A CARDIAC TAMPONADE OCCURRED AND THE PATIENT EXPIRED. WHILE PERFORMING THE TRANSSEPTAL APPROACH, THE PATIENT'S BLOOD PRESSURE DROPPED FROM 110 TO 40. AN ECHOCARDIOGRAM WAS DONE WHICH IDENTIFIED A CARDIAC TAMPONADE. A PERICARDIOCENTESIS AND TRANSFUSION WERE PERFORMED, A TOTAL OF 1.5L WAS DRAINED. DURING THE PERICARDIOCENTESIS, THE PATIENT WENT INTO CARDIAC ARREST. CARDIAC MASSAGE WAS DONE BUT WAS UNSUCCESSFUL AND THE PATIENT DECEASED. THE PHYSICIAN BELIEVED THAT THE AORTA WAS PERFORATED BY THE SHEATH AND DILATOR DURING THE TRANSSEPTAL APPROACH.

  Patient problems: Cardiac Perforation; Great Vessel Perforation

  MAUDE report 20136421 ↗
• InjuryAug 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THERE WAS A PERICARDIAL EFFUSION. AT THE BEGINNING OF THE PROCEDURE, THE TACTISYS QUARTZ DID NOT READ THE CONTACT FORCE, AND NO RESET WAS POSSIBLE. WHEN THE FIRST TACTICATH SE CATHETER WAS CONNECTED, PRIOR TO INSERTION INTO THE PATIENT, THE CONTACT FORCE INFORMATION WAS STILL UNAVAILABLE. THE TACTICATH SE CATHETER WAS EXCHANGED, BUT THE ISSUE WAS DID NOT RESOLVE. THE PROCEDURE WAS THEN CONTINUED WITH THE SECOND TACTICATH SE CATHETER, DESPITE HAVING NO CONTACT FORCE INFORMATION. MAPPING WAS STARTED WITH AN INQUIRY AFOCUS MAPPING CATHETER BUT WAS BEING FINISHED IN THE LEFT ATRIUM WITH THE TACTICATH SE CATHETER WHEN THE TRANSSEPTAL ACCESS WAS LOST AND THE TACTICATH SE CATHETER WAS BACK IN THE RIGHT ATRIUM. THE PATIENT BECAME HYPOTENSIVE, AND A TRANSESOPHAGEAL ECHOCARDIOGRAM WAS PERFORMED SHOWING A PERICARDIAL EFFUSION. THE PERICARDIAL EFFUSION WAS NOTED ON THE ANTERIOR PART OF THE HEART BETWEEN THE RIGHT AND LEFT ATRIUM. NO INTERVENTION WAS ADMINISTERED AS THE PERICARDIAL EFFUSION SPONTANEOUSLY RESOLVED ON ITS OWN. THE PHYSICIAN ALLEGES THAT THE PERFORATION OCCURRED DURING TRANSSEPTAL PUNCTURE WITH THE BRK TRANSSEPTAL NEEDLE OR WHEN MANEUVERING

  Patient problems: Cardiac Perforation

  MAUDE report 19986832 ↗
• InjuryJul 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PREMATURE VENTRICULAR CONTRACTION OF LEFT VENTRICLE PROCEDURE, A TAMPONADE OCCURRED WHICH REQUIRED A PERICARDIOCENTESIS TO STABILIZE THE PATIENT. WHILE MAPPING, IT WAS NOTICED THAT THE MAPPING CATHETER WAS IN THE EPICARDIUM. THE PATIENT'S BLOOD PRESSURE DROPPED AND PRESENTED THORACIC PAIN. AN ECHOCARDIOGRAM WAS DONE WHICH REVEALED A PERICARDIAL EFFUSION AND TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED, 500ML WAS DRAINED, AND THE PATIENT STABILIZED. THE PHYSICIAN BELIEVES THE EFFUSION IS DUE TO A TRANSSEPTAL PUNCTURE, WHICH WAS NOTED TO BE POSTERIOR AND HAD BEEN DONE WITH SCOPE (NO ETO). THERE WERE NO REPORTED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 19793283 ↗
• MalfunctionJul 1, 2024Fracture; Improper or Incorrect Procedure or Method; Fracture; Improper or Incorrect Procedure or Method

  THIS REPORT IS TO ADVISE OF A FRACTURE FOUND ON THE BRK NEEDLE DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19652556 ↗
• InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DAY AFTER A LEFT ATRIUM ACCESSORY PATHWAY ABLATION PROCEDURE, A PERICARDIAL EFFUSION WAS DIAGNOSED WHICH REQUIRED A PERICARDIOCENTESIS TO STABILIZE THE PATIENT. THE DAY AFTER THE PROCEDURE, THE PATIENT PRESENTED WITH HEART PAIN. AN ECHOCARDIOGRAM WAS DONE WHICH DIAGNOSED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED WHICH DRAINED 250-300ML AND THE PATIENT STABILIZED. THE PHYSICIAN IS UNSURE WHEN THE EFFUSION OCCURRED BUT SUSPECTS IT COULD HAVE OCCURRED EITHER DURING THE TRANSSEPTAL PUNCTURE, WHICH WAS PERFORMED WITH FLUOROSCOPY (NO ETO), OR DURING ABLATION. THERE ARE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 19634171 ↗
• MalfunctionApr 16, 2024Fracture; Fracture

  DURING THE ATRIAL FIBRILLATION PROCEDURE, WHEN REMOVING THE NEEDLE FROM THE INTRODUCER, IT WAS NOTED THAT THE NEEDLE WAS FRACTURED. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19116286 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATYPICAL FLUTTER FOR A CONGENITAL HEART (TRIDUX SURGERY), THE AORTA WAS PERFORATED. THE INTRODUCER WAS REMOVED, PATIENT REMAINED STABLE, AND THE PROCEDURE WAS COMPLETED. DURING THE TRANSSEPTAL PUNCTURE, THE AORTA WAS PERFORATED. FLUOROSCOPY CONFIRMED THE GUIDEWIRE AND DILATOR TIP WERE IN THE AORTA 1CM ABOVE THE AORTIC VALVES. CARDIOTHORACIC SURGEONS WERE CALLED TO ADVISE. STRUCTURAL ABNORMALITIES OF THE HEART ASSOCIATED WITH PREVIOUS SURGICAL PROCEDURES CAUSE THE REFLUX TO OCCUR BETWEEN THE AORTA AND THE RIGHT ATRIUM AND NOT TOWARDS THE PERICARDIUM. THE MEDICAL TEAM DECIDED TO REMOVE THE SHEATH AND GUIDE. THE PATIENT'S BLOOD PRESSURE WAS STABLE SO THE PROCEDURE WAS COMPLETED. PROTAMINE WAS ADMINISTERED AND THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM. THE PATIENT HAS SINCE BEEN DISCHARGED. THERE WERE NO REPORTED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Great Vessel Perforation

  MAUDE report 18977725 ↗
• InjuryNov 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, AFTER TRANSSEPTAL PUNCTURE WAS COMPLETED, IT WAS NOTED WHILE INSERTING THE CATHETER INTO THE LEFT ATRIUM THAT THERE WAS A PERICARDIAL EFFUSION IN THE POSTERIOR SIDE OF THE LEFT VENTRICLE ON THE TRANSESOPHAGEAL ECHOGRAPHY. THE PROCEDURE AND HEPARIN WAS STOPPED AND PROTAMINE WAS ADMINISTERED. TRANSTHORACIC ECHOGRAPHY WAS USED TO CHECK THE EFFUSION, BUT NO DRAINAGE WAS NEEDED AND THE PATIENT IS STABLE. THERE WERE NO ALLEGED ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 18052723 ↗
• InjuryAug 17, 2023Difficult to Insert; Difficult to Insert

  RELATED MANUFACTURING REFERENCE: 3008452825-2023-00360. 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 17568574 ↗
• InjuryJan 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE MITRACLIP PROCEDURE, A PERICARDIAL EFFUSION OCCURRED AND A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THE PATIENT PRESENTED WITH GRADE 4 DEGENERATIVE MITRAL REGURGITATION (MR) AND A FLOPPY SEPTUM. DURING THE PROCEDURE, IT WAS NOTED THAT DUE TO THE FLOPPY SEPTUM, THERE WERE DIFFICULTIES KEEPING CONTACT ON THE SEPTUM DURING TRANSSEPTAL PUNCTURE. THE PROCEDURE CONTINUED AND AT THE END OF PROCEDURE, AN ECHOGRAPHY REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES. THE PHYSICIAN'S OPINION IS THAT THE TRANSSEPTAL PUNCTURE COULD HAVE CAUSED THE PERICARDIAL EFFUSION.

  Patient problems: Cardiac Perforation

  MAUDE report 16264112 ↗
• InjuryDec 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE ATRIAL FIBRILLATION PROCEDURE, A TAMPONADE OCCURRED DURING TRANSSEPTAL PUNCTURE WITH THE NEEDLE RESULTING IN CANCELLATION OF THE PROCEDURE. WHEN THE PATIENT BECAME HYPOTENSIVE AN ECHO WAS DONE AND THE TAMPONADE WAS NOTED IN THE AORTA. A PERICARDIOCENTESIS WAS DONE TO STABILIZE THE PATIENT. THE PATIENT IS RECOVERING WITH NO LONG TERM CONSEQUENCES. THERE WERE NO ALLEGED ISSUES WITH ANY ABBOTT PRODUCTS. THE PATIENT HAD A HIGH BMI WHICH MAY HAVE CONTRIBUTED TO THE EVENT.

  Patient problems: Cardiac Perforation

  MAUDE report 15912846 ↗
• InjuryNov 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING AN ATRIAL FIBRILLATION PROCEDURE, AN EFFUSION WAS NOTED IN THE RIGHT ATRIUM REQUIRING A PERICARDIOCENTESIS. DURING THE POST ASSESSMENT, AN ULTRASOUND REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES. THE PHYSICIAN INDICATED THIS OCCURRED DURING TRANSSEPTAL PUNCTURE.

  Patient problems: Cardiac Perforation

  MAUDE report 15714736 ↗
• InjuryOct 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING AN ATRIAL FIBRILLATION PROCEDURE, AN EFFUSION WAS NOTED WITH PROTAMINE ADMINISTERED DURING THE POST ASSESSMENT, AN ECHOCARDIOGRAM WAS PERFORMED, WHICH REVEALED THE EFFUSION. PROTAMINE WAS ADMINISTERED TO STABILIZE THE PATIENT. THE PATIENT WAS STABLE WHEN HE LEFT THE INTERVENTION ROOM.

  Patient problems: Cardiac Perforation

  MAUDE report 15665990 ↗
• InjuryOct 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ACCESSORY PATHWAY PROCEDURE (AT THE LEFT ATRIUM LATERAL WALL), A PERICARDIAL EFFUSION OCCURRED AND A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. TRANSSEPTAL PUNCTURE WAS PERFORMED WHILE POSITIONING THE SHEATH OVER THE OVAL FORAMEN AND PUSHING THE SHEATH INTO THE LEFT ATRIUM. THE GUIDE WAS IN THE LEFT SUPERIOR PULMONARY VEIN ACCORDING TO FLUOROSCOPY. THE DECAPOLAR INQUIRY WAS IN THE CS, THE QUADRIPOLAR INQUIRY WAS IN THE RIGHT ATRIUM AND THE TACTICATH WAS ON THE MITRAL ANNULUS WITH SIGNALS VISIBLE; NO ABLATION WAS PERFORMED. THE PATIENT COMPLAINED OF CHEST PAIN AND AN ULTRASOUND REVEALED A PERICARDIAL EFFUSION (TAMPONADE) FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS STABLE WHEN LEAVING THE OPERATING ROOM.

  Patient problems: Cardiac Perforation

  MAUDE report 15614181 ↗
• InjurySep 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE PATIENT DEVELOPED A PERICARDIAL EFFUSION IN THE LEFT ATRIUM. A DECAPOLAR CATHETER WAS PLACED IN THE SINUS, TRANSSEPTAL PUNCTURE WAS PERFORMED AND A VOLTAGE MAP WAS DONE IN THE LEFT ATRIUM. THE PATIENT BECAME HYPOTENSIVE AND AN ULTRASOUND REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THE PHYSICIAN THINKS THE NEEDLE WENT TOO FAR AND TOO QUICK INTO THE LEFT ATRIUM DURING TRANSSEPTAL PUNCTURE CAUSING THE EFFUSION.

  Patient problems: Cardiac Perforation

  MAUDE report 15476002 ↗