BRK-1™ 407201Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 05414734205160), received between Jul 18, 2018 and Aug 19, 2026 — classified as 24 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (5 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 30 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem

  During the procedure, a pericardial effusion was noted while using a BRK needle. While attempting transseptal puncture, it was aborted due to significant atrial anatomical distortion from previous cardiac surgery. The pericardial effusion was noted during ablation of the cavotricupsid isthmus. A pericardiocentesis was perform with 120 ml of blood drained. The patient stabilized with no growth of the effusion. The patient remained stable with no complication after the pericardiocentesis.

  Patient problems: Cardiac Perforation

  MAUDE report 50330766 ↗
• InjuryMay 30, 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 DURING TRANSEPTAL PUNCTURE. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT.

  Patient problems: Cardiac Perforation

  MAUDE report 22116907 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A CARDIAC EFFUSION OCCURRED REQUIRING A PERICARDIOCENTESIS. WHILE MAPPING IN THE LEFT ATRIUM, THE PATIENT BECAME HYPOTENSIVE. AN ULTRASOUND REVEALED A CARDIAC EFFUSION AND A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THE PHYSICIAN ALLEGES THAT THE EVENT OCCURRED DURING TRANSSEPTAL PUNCTURE AND THAT THERE WERE NO ADVERSE EVENTS CAUSED BY ABBOTT PRODUCTS.

  Patient problems: Cardiac Perforation

  MAUDE report 21621760 ↗
• MalfunctionOct 22, 2024Gas/Air Leak; Gas/Air Leak

  DURING A PULSE FIELD ABLATION (PFA) PROCEDURE, THE PHYSICIAN WAS UNABLE TO CLEAR AIR FOLLOWING INSERTION OF THE NEEDLE. AFTER MULTIPLE ATTEMPTS TO CLEAR THE AIR, A NEW NEEDLE WAS USED TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20509211 ↗
• InjuryOct 13, 2024Difficult to Insert; Difficult to Insert

  DURING A PAROXYSMAL ATRIAL FIBRILLATION THERE WAS A CARDIAC TAMPONADE. ACCESS WAS GAINED THROUGH THE LEFT FEMORAL VEIN. FIRST, THE INQUIRY 10 POLE CATHETER WAS INSERTED, FOLLOWED BY AN AGILIS SHEATH AND BRK NEEDLE. THERE WAS DIFFICULTY ENTERING THE LEFT ATRIUM VIA THE SEPTUM, SO ULTRASOUND WAS USED. MAPPING OF THE LEFT ATRIUM WAS THEN COMPLETED WITH AN ADVISOR SE CATHETER WITH THE PATIENT STILL IN SINUS RHYTHM. THE TACTIFLEX SE CATHETER WAS THEN INSERTED, AND ABLATION WAS STARTED ON THE LEFT PULMONARY VEINS FROM THE ROOF ON THE POSTERIOR WALL. WHEN THE POSTERIOR SIDE WAS COMPLETED, ABLATION WAS MOVED TO THE ANTERIOR SIDE. THE PATIENT THEN BECAME HYPOTENSIVE, AND WEAK, WITH SLOW RESPONSIVENESS. A CARDIAC TAMPONADE WAS SEEN ON FLUOROSCOPY AND THEN WAS CONFIRMED WITH ULTRASOUND. A PERICARDIOCENTESIS WAS PERFORMED AND ANTI-HEPARIN WAS ADMINISTERED. THERE WAS STILL BLOOD ACCUMULATION, SO THE PATIENT WAS INTUBATED AND UNDERWENT CARDIAC SURGERY FOR REPAIR. THE PATIENT IS STABLE. THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH THE ABLATION CATHETER. ALL ABBOTT RECOMMENDATIONS AND USAGE OF THE ABLATION CATHETER WERE ACCORDING TO THE INSTRUCTION FOR USE. THE PHYSICIAN ALLEGES THAT THE CARDIAC

  Patient problems: Cardiac Perforation

  MAUDE report 20436586 ↗
• InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A CARDIAC TAMPONADE OCCURRED WHICH REQUIRED A PERICARDIOCENTESIS TO STABILIZE THE PATIENT. DURING THE TRANSSEPTAL PUNCTURE IN THE RIGHT ATRIUM, THE PATIENT'S BLOOD PRESSURE WAS NOTED TO BE LOW. AN ECHOCARDIOGRAM WAS DONE WHICH REVEALED A CARDIAC TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT AND THE PATIENT WAS TRANSFERRED TO THE ICU FOR FOLLOW UP. THERE ARE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 19636083 ↗
• InjuryMar 20, 2024Device Contamination with Body Fluid; Device Contamination with Body Fluid

  DURING AN ATRIAL FIBRILLATION ABLATION, A CLOT OCCURRED WHICH RESULTED IN THE CANCELLATION OF THE PROCEDURE. IN ADDITION, THERE WERE COMMUNICATION ISSUES WITH THE AMPLIFIER. WHEN THE ABLATION CATHETER WAS INSERTED, IT WAS UNSTABLE. BREATHING WAS COMPENSATED BUT THE CATHETER CONTINUED TO OSCILLATE MORE THAN USUAL. THE AMPLIFIER WAS RECONNECTED AND RESTARTED, BUT THE ISSUE PERSISTED. THEN THE COMPUTER WAS RESTARTED, AND A NEW MAP WAS COMPLETED WITH THE MAPPING CATHETER. A CLOT WAS THEN DETECTED, SO THE PROCEDURE WAS SUSPENDED AT THAT TIME. A TRANSESOPHAGEAL ECHOCARDIOGRAPHY WAS DONE PRIOR TO THE PROCEDURE AND THERE WERE NO CLOTS NOTED AT THAT TIME. DUE TO THE ISSUE, THE ABLATION CATHETER WAS NOT RE-INTRODUCED INTO THE PATIENT, AND IT WAS NOT VERIFIED WHETHER THE ISSUE PERSISTED AFTER RESTARTING THE COMPUTER. THERE WAS NO INTERVENTION NEEDED TO TREAT THE CLOT FOUND DURING THE PROCEDURE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18944408 ↗
• InjuryMar 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A MITRACLIP PROCEDURE TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 3-4 AND PRE-EXISTING CHORDAL RUPTURE, A CARDIAC PERFORATION REQUIRING PERICARDIOCENTESIS OCCURRED ON THE ANTERIOR WALL OF THE LEFT ATRIUM. AFTER TRANSSEPTAL PUNCTURE, THE PATIENT BECAME HYPOTENSIVE. AN ECHOCARDIOGRAM WAS PERFORMED AND REVEALED A PERICARDIAL EFFUSION. AFTER AN EPICARDIAL PUNCTURE, THE BLOOD PRESSURE STABILIZED. AFTER MORE THAN 30 MINUTES, THE BLEEDING TO THE PERICARDIUM HAD NOT STOPPED. THE PROCEDURE WAS DISCONTINUED WITH NO CLIPS IMPLANTED. THE MR REMAINED AT A GRADE OF 3-4. SURGICAL INTERVENTION WAS NOT REQUIRED AS THE BLEEDING STOPPED WITHOUT FURTHER INTERVENTION. THE PATIENT LEFT THE INTENSIVE CARE UNIT (ICU) EXTUBATED IN STABLE CONDITION. IT WAS NOTED THAT THE PREPPED STEERABLE GUIDE CATHETER (SGC) WAS NOT IN CONTACT WITH THE PATIENT. THE STEERABLE GUIDE CATHETER DID NOT CAUSE OR CONTRIBUTE TO ANY PATIENT ADVERSE EFFECTS. NO MITRACLIP DEVICES WERE INSERTED DURING THE PROCEDURE. THERE ARE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVIES. THE STEERABLE GUIDE CATHETER DID NOT CAUSE OR CONTRIBUTE TO ANY PATIENT ADVERSE EFFECT. NO MITRACLIP DEVICES WERE INSERTED DURING T

  Patient problems: Cardiac Perforation

  MAUDE report 18823604 ↗
• MalfunctionSep 1, 2023Gas/Air Leak; Gas/Air Leak

  DURING THE PULMONARY VEIN ISOLATION ATRIAL FIBRILLATION PROCEDURE, THE NEEDLE WAS PLACED INTO THE RIGHT ATRIUM AND WHEN DRAWING BACK ON THE LUER LOCK SYRINGE AN AIR LEAK OCCURRED. 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 17670587 ↗
• InjuryJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT THE BEGINNING OF THE ATRIAL FIBRILLATION PROCEDURE, DURING TRANSSEPTAL PUNCTURE, THERE WAS A CARDIAC TAMPONADE WHICH REQUIRED A PERICARDIOCENTESIS. WHEN GOING TRANSEPTAL WITH THE NEEDLE THE PATIENT FELT CHEST PAIN AND AFTER A WHILE THE BLOOD PRESSURE DROPPED. FLUOROSCOPY AND AN ECHOCARDIOGRAM CONFIRMED THAT THERE WAS FLUID IN THE PERICARDIUM. A PERICARDIOCENTESIS WAS PERFORMED WHICH STABILIZED THE PATIENT; HOWEVER, THE CASE WAS TERMINATED. THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 17239265 ↗
• MalfunctionJun 21, 2023Improper or Incorrect Procedure or Method; Gas/Air Leak; Improper or Incorrect Procedure or Method; Gas/Air Leak

  DURING THE ATRIOVENTRICULAR REENTRANT TACHYCARDIA/LEFT LATERAL ACCESSORY PATHWAY ABLATION PROCEDURE, AN AIR LEAK OCCURRED. THE NEEDLE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES. WHEN THE NEEDLE WAS INSERTED INTO THE SHEATH AND WAS ATTEMPTED TO BE MANUALLY FLUSHED PRIOR TO TRANSSEPTAL PUNCTURE, AIR BUBBLES WERE NOTICED TO BE CONSISTENTLY PULLED BACK WITH THE SALINE SYRINGE. THE PHYSICIAN BELIEVES IT WAS AN ISSUE WITH THE VALVE ON THE NEEDLE ITSELF. THE NEEDLE WAS REPLACED WITH ANOTHER NEEDLE AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES. IT WAS CONFIRMED THAT THE PHYSICIAN UTILIZED A LUER LOCK SYRINGE WITH THE TRANSSEPTAL NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17174966 ↗
• InjuryApr 4, 2023Difficult to Insert; Dull, Blunt; Difficult to Insert; Dull, Blunt

  DURING A PREMATURE VENTRICULAR CONTRACTION PROCEDURE, THE TIP OF THE NEEDLE WAS BLUNT AND COULD NOT BE INSERTED INTO THE SEPTUM. ANOTHER DEVICE WAS USED VIA AN ADDITIONAL FEMORAL PUNCTURE SITE TO COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16677245 ↗
• InjuryAug 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT THE END OF THE IMPLANT PROCEDURE, AFTER RELEASING THE PROSTHESIS, A PERICARDIAL EFFUSION WAS NOTED VIA TRANSESOPHAGEAL ECHO. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. NO FURTHER INTERVENTION WAS REQUIRED.

  Patient problems: Cardiac Perforation

  MAUDE report 15156312 ↗
• InjuryMay 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A TAMPONADE OCCURRED. WHEN PERFORMING THE FIRST TRANSSEPTAL PUNCTURE, THE PHYSICIAN PUNCTURED THE EPICARDIUM (BUFFERING) AND A FLUOROSCOPY REVEALED A CARDIAC PERFORATION AT THE POSTERIOR WALL OF THE SEPTAL REGION. SOON AFTER, THE DOCTOR USED A TECHNIQUE PUBLISHED IN AN ARTICLE BY HIMSELF IN WHICH HE USES A SHEATH AND HEMODYNAMIC CATHETER TO CONTAIN ANY BLEEDING FROM THE TAMPONADE. THE PROCEDURE CONTINUED WITH ONLY ONE TRANSSEPTAL PUNCTURE, MAPPING WAS PERFORMED WITH AN HDGRID CATHETER, AND THE PULMONARY VEINS WERE ISOLATED WITH THE TACHTCATH. THE PATIENT WAS EXTUBATED NORMALLY, WAS CONSCIOUS AND WITHOUT ANY COMPLICATIONS, AND WAS EXPECTED TO BE DISCHARGED THE NEXT DAY. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 14280037 ↗
• MalfunctionFeb 7, 2022Gas/Air Leak; Gas/Air Leak

  DURING THE CRYO ATRIAL FIBRILLATION PROCEDURE, AIR WAS ASPIRATED INTO THE SYRINGE. TROUBLESHOOTING STEPS DID NOT RESOLVE THE ISSUE. 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 13476775 ↗
• InjuryJan 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A PERFORATION OCCURRED DURING THE TRANSSEPTAL PUNCTURE NEAR THE FOSSA OVALIS. MOREOVER, WHEN ATTEMPTING THE TRANSSEPTAL PUNCTURE, A HIGH AMOUNT OF RESISTANCE WAS FELT AND THE TISSUE BECAME COLORED WITH CONTRAST. THE PATIENT THEN BECAME HYPOTENSIVE AND A PERICARDIAL EFFUSION WAS DIAGNOSED VIA TRANSTHORACIC ECHOCARDIOGRAM. THE PROCEDURE WAS THEN CANCELLED AND HEPARIN WAS ADMINISTERED TO THE PATIENT. THE PATIENT REMAINED STABLE AND NO PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS THEN SENT TO THE INTENSIVE CARE UNIT FOR MONITORING. THERE WERE NO PERFORMANCE ISSUES WITH THE ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 13385214 ↗
• InjuryDec 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, AFTER PERFORMING THE TRANSSEPTAL PUNCTURE, CONTRAST INJECTION SHOWED UP AS A COLLECTION IN THE PERICARDIUM AND IT WAS BELIEVED THAT THE TRANSSEPTAL NEEDLE PERFORATED THE PERICARDIUM. A PERICARDIAL EFFUSION WAS THEN DIAGNOSED VIA ECHOCARDIOGRAM AND FLUOROSCOPY. NO PATIENT SYMPTOMS WERE NOTED. THE PROCEDURE WAS CANCELLED WITH NO INTERVENTION NEEDED AND THE PATIENT WAS NOTED TO BE STABLE. THERE WERE NO PERFORMANCE ISSUES WITH THE ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 13024726 ↗
• MalfunctionFeb 8, 2021Gas/Air Leak; Gas/Air Leak

  DURING THE PROCEDURE, WHEN PULLING BACK THE SYRINGE TO FLUSH NEEDLE, AIR ENTERED THE SYRINGE. THE NEEDLE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11298721 ↗
• InjuryJan 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT THE END OF AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A PERICARDIAL EFFUSION WAS NOTED. TRANSSEPTAL PUNCTURE WAS COMPLICATED AND AN ECHOCARDIOGRAM WAS PERFORMED REGULARLY THROUGHOUT THE PROCEDURE. JUST AFTER TRANSSEPTAL PUNCTURE, AN ECHOCARDIOGRAM WAS DONE, AND THE PROCEDURE CONTINUED. THE PATIENT RECEIVED HEPARIN AND WHEN GEOMETRY WAS FINISHED, AND A PERICARDIAL EFFUSION WAS NOTED VIA ECHOCARDIOGRAM. HOWEVER, THE USER DECIDED TO CONTINUE THE PROCEDURE. WHEN THE PULMONARY VEINS WERE ISOLATED, THE PROCEDURE WAS STOPPED AS THE EFFUSION WAS LARGER, AND THE PATIENT BECAME HYPOTENSIVE. A PERICARDIOCENTESIS WAS PERFORMED WHICH STABILIZED THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 11214407 ↗
• InjuryJan 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL TACHYCARDIA ABLATION PROCEDURE FOR THE LEFT ATRIUM, WHILE CONDUCTING THE TRANSSEPTAL PUNCTURE, A PERFORATION WAS NOTED ON ONE OF THE LEAFLETS OF THE AORTIC VALVE. AFTER PERFORMING THE TRANSSEPTAL PUNCTURE, WHEN PASSING THE GUIDEWIRE THROUGH, THE GUIDEWIRE WENT DOWN INTO THE AORTA. THE PERFORATION WAS DIAGNOSED INITIALLY WITH ULTRASOUND AND THEN LATER VIA INTRACARDIAC ECHOCARDIOGRAM. THE PROCEDURE WAS THEN CANCELLED AND NO INTERVENTION WAS ADMINISTERED. THERE WERE NO PERFORMANCE ISSUES WITH THE ABBOTT PRODUCT.

  Patient problems: Great Vessel Perforation

  MAUDE report 11154456 ↗
• InjuryNov 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REF: 3005334138-2020-00484. DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, DURING EITHER THE TRANSSEPTAL PUNCTURE OR DURING INITIAL MAPPING, A CARDIAC PERFORATION OCCURRED. AFTER THE TRANSSEPTAL PUNCTURE WAS PERFORMED UNDER INTRACARDIAC ECHOCARDIOGRAPHY WITH A NON-ABBOTT GUIDEWIRE THROUGH A BRK NEEDLE AND INTRODUCED, THE CATHETER WAS INTRODUCED INTO THE LEFT ATRIUM. WHILE CREATING THE GEOMETRY, A PERICARDIAL EFFUSION WAS NOTED ON INTRACARDIAC ECHOCARDIOGRAPHY IN THE DOME OF THE LEFT ATRIUM AND THE PROCEDURE WAS CANCELLED. THE PATIENT WAS NOTED TO BE HYPOTENSIVE. THE PATIENT WENT INTO SURGERY WHERE A PERICARDIOCENTESIS WAS PERFORMED, VASOPRESSORS AND BLOOD TRANSFUSIONS WERE GIVEN, AND THORACIC SURGICAL INTERVENTION WAS CONDUCTED TO REPAIR THE TEAR IN THE DOME OF THE LEFT ATRIUM. THE PATIENT WAS NOTED TO BE IN A STABLE CONDITION. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT PRODUCTS.

  Patient problems: Cardiac Perforation

  MAUDE report 10779828 ↗
• InjuryOct 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 3008452825-2020-00585; 3005334138-2020-00530; 3005334138-2020-00531; 3008452825-2020-00583. DURING THE PROCEDURE, A PERICARDIAL EFFUSION WAS OBSERVED. AFTER COMPLETING LEFT ATRIAL GEOMETRY AND VOLTAGE MAPPING AND DOING AN INFERIOR POSTERIOR WALL RADIOFREQUENCY ABLATION LINE AT 45 WATTS AND 40 DEGREES, THE ACCESS SHEATH WAS PULLED TO THE RIGHT ATRIUM, AND THE SUPERIOR VENA CAVA WAS ABLATED AT 25 WATTS. THE PATIENT BECAME HYPOTENSIVE, AND INTRACARDIAC ECHOCARDIOGRAPHY WAS USED TO CHECK FOR AN EFFUSION WITH TRANS-THORACIC ECHOCARDIOGRAPHY CONFIRMING A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS STABLE UPON LEAVING THE LAB.

  Patient problems: Cardiac Perforation

  MAUDE report 10738641 ↗
• InjuryOct 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: 3008452825-2020-00522, 3005334138-2020-00469, 3008452825-2020-00524. DURING THE ATRIAL FIBRILLATION ABLATION PROCEDURE, A PERICARDIAL EFFUSION WAS NOTED FOLLOWING TRANSSEPTAL PUNCTURE AND COLLECTION OF LEFT ATRIUM POINTS. AN ICE CATHETER CONFIRMED THE EFFUSION AND A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT.

  Patient problems: Cardiac Perforation

  MAUDE report 10642526 ↗
• InjuryJul 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REFERENCE:(B)(4).

  Patient problems: Edema; Stroke/CVA

  MAUDE report 10307215 ↗
• InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. THE TRANSSEPTAL PUNCTURE WAS NOTED TO BE DIFFICULT AND THE GUIDEWIRE WAS SEEN TO ADVANCE INTO THE PERICARDIAL SPACE ON FLUOROSCOPY AND ECHOCARDIOGRAM. CONTRAST WAS INJECTED AND MODERATE STAINING IN THE SUPERIOR PERICARDIUM WAS SEEN. THE PATIENT REMAINED STABLE AND NO INTERVENTION WAS REQUIRED BUT THE PROCEDURE WAS CANCELLED. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 8950721 ↗