BRK™ G407211Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 05414734205153), received between Nov 2, 2018 and May 26, 2026 — classified as 2 deaths, 21 injuries.

The most frequently reported specific device problem is “Device Contamination with Body Fluid” (1 report).

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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• 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 25273582 ↗
• DeathFeb 24, 2026Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  DURING THE ATRIAL FIBRILLATION WITH PULSED FIELD ABLATION, A CARDIAC EFFUSION OCCURRED THAT RESULTED IN PATIENT DEATH. THE TRANSSEPTAL PUNCTURE WAS PERFORMED WITH THE BRK NEEDLE AND 13F SHEATH GUIDED BY ETO WITH NO ISSUE. AFTER THE PUNCTURE, A 0.035 WIRE WAS INSERTED INTO THE LSPV AND CONFIRMED BY THE FLUOROSCOPY. THE PFA CATHETER WAS INSERTED INTO THE LA, THE PHYSICIAN FILLED IT AND STARTED THE CONTACT BASELINE ON THE POSTERIOR WALL WITH NO ISSUE. THE LSPV WAS ISOLATED WITH NO ISSUE. THEN THE 0.035 WIRE WAS INSERTED INTO THE LIPV AND CONFIRMED WITH FLUOROSCOPY. THE PHYSICIAN MOVED THE PFA CATHETER AND 13F SHEATH FROM THE LSPV WITH THE 0.35 WIRE RETRIEVED CLOCKWISE AND INSERTED THE GUIDEWIRE INTO THE LIPV. THE PFA CATHETER WAS MOVED TOWARD THE VEIN BUT DURING ISOLATION, THE ANESTHETIST NOTED A DROP ON C02 EXPIRED. THE PHYSICIAN LOOKED ON FLUOROSCOPY AND NOTED NO CARDIAC CONTRACTION. CARDIAC EFFUSION WAS CONFIRMED WITH TTE. A PERICARDIOCENTESIS WAS PERFORMED AND WHILE DRAINING, ADRENALINE WAS INJECTED TO INCREASE CARDIAC RHYTHM. AT THE SAME TIME, A CS CATHETER WAS INSERTED IN THE RV TO STIMULATE BUT THE HEART WAS NOT CONTRACTED, CONFIRMING AN ELECTRO-MECHANIC DISSOCIATION. A CARDIAC

  Patient problems: Cardiac Perforation

  MAUDE report 24431038 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION WHICH REQUIRED A PERICARDIOCENTESIS. THE TRANSEPTAL PUNCTURE WAS NOTED TO BE DIFFICULT RELATED TO PATIENT ANATOMY. WHILE MAPPING IN THE LEFT ATRIUM, A DROP IN BLOOD PRESSURE WAS OBSERVED. AN ULTRASOUND WAS DONE WHICH REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT STABILIZED. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 23648726 ↗
• InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION (PVI) ATRIAL FIBRILLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED WHICH REQUIRED A PERICARDIOCENTESIS TO STABILIZE THE PATIENT. PVI HAD STARTED BUT STOPPED WHEN IT WAS NOTED THAT THE PATIENT WAS NOT HEMODYNAMICALLY STABLE. AN ULTRASOUND WAS DONE WHICH REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED, THE PATIENT REMAINED STABLE. DURING THE TRANSSEPTAL PUNCTURE, THE PUNCTURE WAS PERFORMED TOO FAR POSTERIORLY AND ENDED UP IN THE PERICARDIUM INSTEAD OF THE LEFT ATRIUM. IT IS THOUGHT THAT THIS LIKELY RESULTED IN THE PERICARDIAL EFFUSION. THERE WERE NO REPORTED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 21265042 ↗
• InjuryJan 22, 2025Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED WHICH REQUIRED A PERICARDIOCENTESIS TO STABILIZE THE PATIENT. BECAUSE THE HANDLE OF THE NEEDLE BROKE WHILE PERFORMING TRANSEPTAL PUNCTURE (THE PROXIMAL PART OF THE DEVICE OUTSIDE OF THE PATIENT, A PERICARDIAC EFFUSION OCCURRED AND A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. BECAUSE THE PATIENT WAS FINE, THE PHYSICIAN DECIDED TO CONTINUE THE PROCEDURE WITH A 2ND NEEDLE. THE PROCEDURE WAS COMPLETED AND THE PATIENT IS FINE.

  Patient problems: Cardiac Perforation

  MAUDE report 21210671 ↗
• InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE ABLATION PROCEDURE, A CARDIAC TAMPONADE OCCURRED, AND A DRAINAGE WAS PERFORMED. THE TRANSSEPTAL PUNCTURE WAS PERFORMED, AND IT WAS NOTED TO BE DIFFICULT AS THE LOCATION WAS FIBROUS DUE TO PERVIOUS TRANSSEPTAL CROSSINGS. AFTER THE LEFT ATRIAL ACCESS WAS GAINED, IT WAS NOTED THAT THE PATIENT'S BLOOD PRESSURE DROPPED. WHEN THE ULTRASOUND WAS CONDUCTED, A CARDIAC TAMPONADE WAS OBSERVED. THE ABLATION PROCEDURE WAS CANCELLED AT THIS TIME, AND A DRAINAGE WAS PERFORMED. NO FURTHER PATIENT COMPLICATIONS WERE NOTED.

  Patient problems: Cardiac Perforation

  MAUDE report 20256909 ↗
• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATYPICAL ATRIAL FIBRILLATION PROCEDURE IN THE LEFT ATRIUM, AN AORTIC PERFORATION OCCURRED WHICH REQUIRED TREATMENT. WHILE PERFORMING THE TRANSSEPTAL PUNCTURE, THE AORTA WAS PUNCTURED WITH THE NEEDLE. THIS WAS NOTED ON X-RAY AND THE PROCEDURE WAS STOPPED IMMEDIATELY. THE PATIENT REMAINED STABLE, AN ECHOCARDIOGRAM WAS DONE AND THE PATIENT WAS CONTINUALLY MONITORED. THERE WAS NO PERICARDIUM PUNCTURE. THERE WERE NO PERFORMANCE ISSUES WITH THE DEVICE.

  Patient problems: Great Vessel Perforation

  MAUDE report 20013562 ↗
• InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PERSISTENT ATRIAL FIBRILLATION PROCEDURE IN THE LEFT ATRIUM, A PERICARDIAL EFFUSION WAS NOTED, REQUIRING A PERICARDIOCENTESIS AND SURGERY. THE PULMONARY VEINS WERE FULLY ISOLATED WITH A TACTICATH SE ABLATION CATHETER. THE PATIENT THEN BECAME HYPOTENSIVE, AND A PERICARDIAL EFFUSION WAS DIAGNOSED VIA ULTRASOUND. IT IS ALLEGED THAT THE PERFORATION OCCURRED DURING TRANSSEPTAL PUNCTURE. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL, PRINCESS GRACE HOSPITAL, FOR CARDIAC SURGERY. DURING SURGERY, THE PERFORATION WAS FOUND BETWEEN THE LEFT VEINS IN THE LEFT ATRIUM. THE PATIENT IS NOW STABLE. THE PHYSICIAN ALLEGES THAT THE PERFORATION OCCURRED DUE TO PATIENT ANATOMY, SUCH AS A RECESS, BUT THERE WAS NO SCAN TO IDENTIFY THIS PRIOR TO THE PROCEDURE.

  Patient problems: Cardiac Perforation

  MAUDE report 19644422 ↗
• InjuryMar 15, 2024Device Contamination with Body Fluid; Device Contamination with Body Fluid

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A CLOT WAS NOTED IN THE NEEDLE. THE PHYSICIAN HAD JUST CROSSED OVER TO THE LEFT ATRIUM WHEN IT WAS NOTED THAT HE COULD NO LONGER FLUSH THE NEEDLE. THE DILATOR WAS LEFT ACROSS AND THE NEEDLE WAS REMOVED. WHEN FLUSHING THE NEEDLE ON THE STERILE TABLE, A LARGE CLOT WAS NOTED WITHIN THE NEEDLE. THE SHEATH WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18913777 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE ATRIAL FIBRILLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED WHICH WAS DIAGNOSED WITH AN ECHOCARDIOGRAM. THIS RESULTED IN THE DISCONTINUATION OF THE PROCEDURE AND MONITORING OF THE PATIENT UNTIL STABLE. AT THE END OF THE PROCEDURE, IT WAS NOTED THAT THE PATIENT'S BLOOD PRESSURE HAD DROPPED. AN ECHOCARDIOGRAM WAS PERFORMED, AND A SMALL PERICARDIAL EFFUSION WAS DIAGNOSED. THE PHYSICIAN STOPPED THE PROCEDURE, AND THE PATIENT WAS MONITORED UNTIL STABLE. THE PATIENT WAS THEN TRANSFERRED TO THE INTENSIVE CARE UNIT FOR OBSERVATION. THERE ARE NO REPORTED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE IN THIS EVENT.

  Patient problems: Cardiac Perforation

  MAUDE report 17175028 ↗
• InjuryAug 16, 2022Difficult to Insert; Difficult to Insert

  DURING A PERSISTENT ATRIAL FIBRILLATION ABLATION PROCEDURE, AN EFFUSION OCCURRED. TWO TRANSSEPTAL PUNCTURES WERE PERFORMED TO ADVANCE THE CATHETERS INTO THE LEFT ATRIUM (LA) AT THE SAME TIME. THE FIRST TRANSSEPTAL PUNCTURE WENT FINE, HOWEVER, THE SECOND SEEMED MORE DIFFICULT TO THE PHYSICIAN. JUST AFTER THE SECOND PUNCTURE, AN ECHOCARDIOGRAM WAS DONE WHICH CONFIRMED THERE WAS NO EFFUSION. THE PATIENTS VITALS WERE NORMAL AND STABLE. AFTER MAPPING, ABLATION OF THE ROOF LINE AND ANTERIOR LINE WERE COMPLETED. THE PATIENT BECAME HYPOTENSIVE AND A RECHECK ECHO REVEALED AN EFFUSION ALL AROUND THE HEART. A PERICARDIOCENTESIS WAS PERFORMED WHICH STABILIZE THE PATIENT AND THE PROCEDURE WAS STOPPED. THE PHYSICIAN ASSUMED THE EFFUSION OCCURRED AFTER THE SECOND TRANSEPTAL PUNCTURE WITH THE NEEDLE.

  Patient problems: Cardiac Perforation

  MAUDE report 15232089 ↗
• InjuryJun 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED DURING TRANSSEPTAL PUNCTURE. THE EFFUSION WAS LIMITED AND STABLE AND THE DECISION WAS MADE TO CONTINUE WITH THE PROCEDURE. A FEW MINUTES FOLLOWING TRANSSEPTAL PUNCTURE, AFTER MAPPING OF THE GEOMETRY AND INSERTION OF THE TACTICATH, THE EFFUSION INCREASED AND THE PROCEDURE WAS STOPPED. THE PATIENT BECAME HYPOTENSIVE AND AN ULTRASOUND REVEALED AN EFFUSION LOCALIZED TO THE RIGHT OF THE HEART, LIKELY IN THE ANTERIOR RIGHT ATRIUM. THE PATIENT WAS TREATED WITH HEART MASSAGE AND A PERICARDIOCENTESIS. THE PROCEDURE WAS STOPPED AND A PERICARDIAL DRAIN WAS PLACED. THE PATIENT IS IN STABLE CONDITION IN THE INTENSIVE CARE UNIT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 14756516 ↗
• InjuryDec 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, THE PATIENT BECAME HYPOTENSIVE AND A PERICARDIAL EFFUSION WAS THEN DIAGNOSED VIA AN ECHOCARDIOGRAM. THE PROCEDURE WAS COMPLETED ENTIRELY AND THEN A PERICARDIOCENTESIS WAS PERFORMED IN ORDER TO STABILIZE THE PATIENT. THE TRANSSEPTAL NEEDLE WAS THOUGHT TO HAVE CAUSED THE PERICARDIAL EFFUSION DURING THE TRANSSEPTAL PUNCTURE. THERE WERE NO PERFORMANCE ISSUES WITH THE ABBOT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 13009616 ↗
• InjuryNov 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, WHEN CONDUCTING THE TRANSSEPTAL PUNCTURE, WHEN THE PHYSICIAN BELIEVED HE PASSED THROUGH THE FORAMEN OVALE, AN EFFUSION ON THE TRANSESOPHAGEAL ULTRASOUND SCREEN WAS NOTED. AFTER WAITING AND MONITORING THE PATIENT'S CONDITION, WHICH REMAINED STABLE, THE PHYSICIAN PREFERRED TO STOP THE PROCEDURE AND SEND THE PATIENT TO INTENSIVE CARE FOR MONITORING. FURTHER FOLLOW-UP REVEALED THE PATIENT WAS STABLE. IT IS UNKNOWN IF INTERVENTION WAS ADMINISTERED OR NOT. THE PHYSICIAN BELIEVED THE PERICARDIAL EFFUSION OCCURRED DUE TO THE TRANSSEPTAL PUNCTURE WITH THE TRANSSEPTAL NEEDLE. THE PERFORATION WAS NOTED TO BE AROUND THE SEPTUM OF THE ATRIUM. NO PATIENT SYMPTOMS WERE NOTED. THERE WERE NO PERFORMANCE ISSUE WITH THE ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 12882231 ↗
• InjuryJun 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REPORT NUMBER: 3008452825-2021-00328. DURING A PAROXYSMAL ATRIAL FIBRILLATION (AF) PROCEDURE, THE AORTA WAS PUNCTURED. DURING REVIEW OF THE X-RAY, THE AORTA BECAME PUNCTURED BY THE NEEDLE AND THE SHEATH. THE PATIENT REMAINED IN STABLE CONDITION, BUT THE PROCEDURE WAS CANCELLED FOR THE SAFETY OF THE PATIENT. IT WAS NOTED THAT THE PUNCTURED AORTA WAS DUE TO THE INCORRECT ANALYSIS OF THE X-RAY BY THE PHYSICIAN. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Great Vessel Perforation

  MAUDE report 12024364 ↗
• DeathMar 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REPORT NUMBERS: 3008452825-2021-00169, 3008452825-2021-00179. DURING AN ATRIAL FIBRILLATION (AF) PROCEDURE, A TAMPONADE OCCURRED AND THE PATIENT PASSED AWAY FOLLOWING THE PROCEDURE. AFTER TRANSSEPTAL PUNCTURE, WHILE MANIPULATING THE ABLATION CATHETER, THE PATIENT BECAME HYPOTENSIVE, AND AN ULTRASOUND REVEALED A CARDIAC TAMPONADE FOR WHICH A DRAIN WAS PLACED TO STABILIZED THE PATIENT. THE PATIENT WAS STABILIZED AND THE PROCEDURE WAS COMPLETED. FOLLOWING THE PROCEDURE THE PATIENT PASSED AWAY. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT PRODUCTS.

  Patient problems: Cardiac Perforation

  MAUDE report 11574085 ↗
• InjuryFeb 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REF: 3008452825-2021-00056, 3008452825-2021-00073. FOLLOWING THE PROCEDURE APPROXIMATELY ONE HOUR LATER, A PERICARDIAL EFFUSION WAS DIAGNOSED VIA ULTRASOUND. A PERICARDIOCENTESIS WAS CONDUCTED AND THE PATIENT WAS STABILIZED. THERE WERE NO PERFORMANCE ISSUES WITH ANY DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 11334922 ↗
• InjuryDec 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, AT THE END A CARDIAC TAMPONADE WAS NOTED VIA ECHOCARDIOGRAM. A BRK NEEDLE WAS USED WITHOUT ISSUES DURING THE PROCEDURE, ALTHOUGH THE TRANSSEPTAL PUNCTURE WAS NOTED TO BE DIFFICULT. THE PATIENT WAS NOTED TO BE STABLE AND NO PERICARDIAL DRAIN WAS NEEDED. THE PROCEDURE WAS STILL COMPLETED. THE PERFORATION WAS BELIEVED TO HAVE OCCURRED AT THE BEGINNING OF THE PROCEDURE.

  Patient problems: Cardiac Perforation

  MAUDE report 11015263 ↗
• InjuryAug 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: 3008452825-2020-00404, 3008452825-2020-00405, 3008452825-2020-00406, 2182269-2020-00071. DURING A PREMATURE VENTRICULAR CONTRACTION (PVC) PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. AFTER 2 HOURS, THE PATIENT BECAME HYPOTENSIVE AND AN ULTRASOUND REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS STABLE WHEN LEAVING THE ROOM. HOWEVER, THE PATIENT WAS THEN TRANSFERRED TO SURGERY FOR REPAIR AND IS IN STABLE CONDITION. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 10414019 ↗
• InjuryJan 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING TRANSSEPTAL PUNCTURE, A PERICARDIAL EFFUSION OCCURRED. CONTRAST MEDIUM WAS USED TO ASSIST DURING TRANSSEPTAL AND IT WAS NOTED THAT THE NEEDLE WAS ON THE SEPTUM WITH TENTING, BUT INTRODUCTION OF THE GUIDEWIRE REVEALED THAT IT WAS NOT IN THE LEFT ATRIUM. THE PATIENT BEGAN TO FEEL UNWELL A FEW SECONDS AFTER PUNCTURE AND WAS TREATED WITH MEDICATION BEFORE A SECOND SUCCESSFUL PUNCTURE. AFTER A WORSENING OF THE PATIENT'S HEMODYNAMIC STATE, AN ULTRASOUND REVEALED A PERICARDIAL EFFUSION FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 9652799 ↗
• InjuryOct 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REFERENCE: 3008452825-2019-00538. DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE A PERICARDIAL EFFUSION OCCURRED. FOLLOWING THE COMPLETION OF THE LEFT SIDED ABLATION THE PATIENT BECAME HYPOTENSIVE. A PERICARDIAL EFFUSION WAS CONFIRMED BY ECHOCARDIOGRAPHY AND A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. ONCE BLOOD PRESSURE WAS STABILIZED THE PATIENT WAS TRANSFERRED TO CARDIAC SURGERY TO REPAIR THE PERFORATION. THE ABLATION PROCEDURE WAS NOT COMPLETED AND THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE. THE USER STATED THE PERFORATION OCCURRED DURING TRANSSEPTAL PUNCTURE WITH THE BRK NEEDLE.

  Patient problems: Cardiac Perforation

  MAUDE report 9249736 ↗
• InjuryFeb 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE: 3008452825-2019-00031, 3008452825-2019-00032, 3008452825-2019-00033, 3005334138-2019-00048. DURING A PULMONARY VEIN ISOLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. FOLLOWING THE ABLATION, AT THE END OF THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE. AN ULTRASOUND CONFIRMED A PERICARDIAL EFFUSION, FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THE LOCATION OF THE EFFUSION REMAINS UNKNOWN. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE DURING THE PROCEDURE.

  Patient problems: Cardiac Perforation

  MAUDE report 8296273 ↗
• InjuryNov 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE: 3008452825-2018-00372, 2030404-2018-00077, 3005334138-2018-00417. DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, FOLLOWING A TRANSSEPTAL PUNCTURE, DURING GEOMETRY CREATION, A CARDIAC PERFORATION WAS NOTED. AN ECHOCARDIOGRAM CONFIRMED A PERFORATION, FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THE LOCATION AND CAUSE OF THE PERFORATION IS UNKNOWN. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE DURING THE PROCEDURE.

  Patient problems: Cardiac Perforation

  MAUDE report 8033402 ↗