TactiCath™ A-TCSE-FJRecalls & reported problems

Summary

The FDA's MAUDE database contains 174 adverse event reports that list this exact device (DI 05415067027665), received between Jun 27, 2018 and Feb 19, 2026 — classified as 3 deaths, 131 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Optical Problem” (15 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jun 9, 2022Class IITerminated

   When connected to the EnSite Precision Navigation System, an affected TactiCath Contact Force Ablation Catheter, Sensor Enabled may present the error message: "invalid catheter,, or "expired catheter."

   Z-1344-2022 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 174 reports, in the reporter's own words as published by the FDA.

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

  DURING AN RVOT PREMATURE VENTRICULAR CONTRACTIONS PROCEDURE, A CARDIAC PERFORATION OCCURRED REQUIRING SURGERY. AN AGILIS SHEATH WAS PLACED INTO THE RIGHT VENTRICLE (RV). THE TACTICATH SE ABLATION CATHETER WAS ADVANCED INTO THE RV. WHILE ATTEMPTING TO MANEUVER FROM THE RV APEX, THE PHYSICIAN ADVANCED THE CATHETER TOWARD THE ANTERIOR SIDE OF THE RV APEX WITH 35 GRAMS AND PERFORATED THROUGH. IMPEDANCE WENT FROM 135 OHMS TO 350 OHMS. THE PATIENT'S BLOOD PRESSURE DROPPED. THE CATHETER WAS WITHDRAWN INTO THE SHEATH. A VIEWFLEX CATHETER VISUALIZED PERICARDIAL FLUID BUILDUP OVER THE RV WHICH WAS VERIFIED WITH TRANSESOPHAGEAL ECHOCARDIOGRAM. A PERICARDIAL DRAIN WAS PLACED AND 400ML WERE REMOVED. A CENTRAL LINE WAS PLACED AND THE PATIENT STABILIZED AND WAS TRANSFERRED TO THE ICU. LATER THE PATIENT UNDERWENT SURGERY FOR A PERICARDIAL WINDOW AND WAS EXTUBATED FROM THE VENT THAT NIGHT. NO ABLATIONS HAD BEEN PERFORMED. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 24387358 ↗
• MalfunctionDec 21, 2025Communication or Transmission Problem; Communication or Transmission Problem

  DURING AN AVNRT ABLATION PROCEDURE, COMMUNICATION ISSUES WITH THE ABLATION CATHETER RESULTED IN A PROCEDURAL DELAY. THE CATHETER WAS CONNECTED, AND IT WAS ABLE TO BE LOCALIZED, CONTACT FORCE INFORMATION WAS SHOWN, AND THERE WAS A GOOD SIGNAL. HOWEVER, WHEN ATTEMPTING TO ABLATE, AN ERROR MESSAGE DISPLAYED ON THE GENERATOR STATING NO CATHETER CONNECTED. THE CATHETER WAS DISCONNECTED, THE GENERATOR AND TACTISYS WERE SWITCHED OFF, THE CABLE BETWEEN THE TACTISYS AND THE GENERATOR WAS CHANGED, AND THE GENERATOR WAS REPLACED, BUT THE ISSUE PERSISTED. THE CATHETER WAS REPLACED WHICH RESOLVED THE ISSUE AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23860348 ↗
• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN AVNRT PROCEDURE, A CARDIAC PERFORATION OCCURRED REQUIRING A PERICARDIOCENTESIS. DURING THE PROCEDURE, WHEN ABLATION WAS BEING PERFORMED THERE WAS AN INCREASE IN CONTACT FORCE OF OVER 40G NOTED. THE PATIENT BECAME HYPOTENSIVE, AND AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 23633814 ↗
• InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, WHEN ABLATING THE INFERIOR AND POSTERIOR LEFT PULMONARY VEIN A CARDIAC TAMPONADE OCCURRED. DURING THE ABLATION THE PHYSICIAN NOTED THAT ON X-RAY THERE WAS SLOWER PUMPING FUNCTION OF THE HEART. A CARDIAC TAMPONADE WAS CONFIRMED USING FLUOROSCOPY. A PERICARDIOCENTESIS WAS PERFORMED AND PATIENT REMAINED STABLE. THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 22777327 ↗
• InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURIG A LEFT ATYPICAL FLUTTER PROCEDURE, A TAMPONADE OCCURRED IN THE ANTERIOR SEPTUM REQUIRING A PERICARDIOCENTESIS TO STABILIZE THE PATIENT. THE PATIENT HAD RADIOTHERAPY, AND CARDIAC TISSUES ARE FRIABLE. WHEN DOUBLING THE TRANSSEPTAL WITH THE ABLATION CATHETER, THE CATHETER PASSED INTO THE PERICARDIUM. THE PATIENT BECAME HYPOTENSIVE, AND AN ECHOCARDIOGRAM REVEALED A TAMPONADE FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THE PATIENT WAS TRANSFERRED TO INTENSIVE CARE IN STABLE CONDITION WITH NORMAL NEUROLOGICAL AND CARDIOLOGICAL EXAMINATIONS. THERE WERE NO PERFORMANCE ISSUES WITH THE ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 22522025 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE, A CARDIAC TAMPONADE OCCURRED DURING ABLATION ON THE MITRAL ISTHMUS. DURING ABLATION, THE PATIENT BECAME HYPOTENSIVE. A TRANSESOPHAGEAL ECHO WAS PERFORMED CONFIRMING THE TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED STABILIZING THE PATIENT. THE SPECIFIC LOCATION OF THE PERFORATION IS UNKNOWN. THERE WERE NO ALLEGED PERFORMANCES ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 22384909 ↗
• InjuryMay 14, 2025Adverse 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 NEAR THE CAVOTRICUSPID ISTHMUS VIA ULTRASOUND. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 22019036 ↗
• InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE, MULTIPLE VENTRICULAR TACHYCARDIAS OCCURRED, NECESSITATING CHEST COMPRESSIONS. THE PATIENT BECAME HYPOTENSIVE AND AN ULTRASOUND REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED, HOWEVER, THE PATIENT WAS TRANSFERRED TO CARDIAC SURGERY. HIS FURTHER STATUS IS UNKNOWN. THERE WERE NO PERFORMANCE ISSUES WITH AN ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 21967852 ↗
• InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A WOLFF-PARKINSON-WHITE PROCEDURE, THE PATIENT HAD A HEART ATTACK, REQUIRING A STENT. THE PATIENT WAS STABLE AT THE END OF THE PROCEDURE, AND DURING THE 15 MINUTES POST ABLATION WAITING PERIOD. HOWEVER, IN THE RECOVERY ROOM THE PATIENT EXPERIENCED CHEST PAIN. A CORONAROGRAPHY REVEALED A SUB-OCCLUSION OF THE MEDIAN CIRCUMFLEX CORONARY ARTERY WHICH REQUIRED DILATION AND STENT PLACEMENT.

  Patient problems: Myocardial Infarction

  MAUDE report 21759335 ↗
• InjuryMar 18, 2025Optical Problem; Optical Problem

  DURING A PREMATURE VENTRICULAR CONTRACTION ABLATION PROCEDURE TARGETING THE ANTEROLATERAL MITRAL ANNULUS, A CARDIAC PERFORATION OCCURRED FOLLOWED BY CARDIAC ARREST REQUIRING CHEST COMPRESSIONS AND CARDIAC SURGERY. WHILE MANIPULATING THE CATHETER FROM THE AORTIC ROOT TO THE LATERAL MITRAL ANNULUS, IT WAS SUSPECTED THAT THE HEART WALL WAS PERFORATED. RF ENERGY HAD NOT BEEN DELIVERED YET IN THE CASE. IT WAS OBSERVED THAT THE CATHETER RECORDED HIGHER THAN NORMAL FORCES FOR PERIODS OF TIME, AND THEN SUDDENLY AN IMPEDANCE VALUE OF 200OHMS WAS NOTED. THE PHYSICIAN WAS INFORMED OF THE FORCE AND HIGH IMPEDANCE. THE CATHETER WAS DRAWN BACK AND CONTINUED TO MANIPULATE THE CATHETER IN THE LEFT VENTRICLE UNTIL A DROP IN BLOOD PRESSURE WAS OBSERVED. FLUOROSCOPY WAS DONE WHICH REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED AND A SURGICAL SEALANT WAS ADMINISTERED IN THE PERICARDIAL SPACE TO TREAT THE BLEEDING AND CONTINUE WITH THE CASE. MULTIPLE SMALL COMPARTMENTS OF BLOOD WERE THEN DETECTED REQUIRING MULTIPLE ADDITIONAL PERICARDIOCENTESIS TO TREAT. THE PATIENT'S BLOOD PRESSURE CONTINUED TO ELEVATE AND DROP AND ADDITIONAL BLEEDING WAS FOUND. FOR THE NEXT 4 HOURS, BLEEDING WAS

  Patient problems: Cardiac Arrest; Cardiac Perforation

  MAUDE report 21631835 ↗
• InjuryFeb 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED WHICH REQUIRED A PERICARDIOCENTESIS TO STABILIZE THE PATIENT. THE PHYSICIAN WAS CREATING A LEFT ATRIAL VOXEL CLOUD PRIOR TO SWITCHING OVER TO THE MAPPING CATHETER. DURING THE INITIAL VOXEL COLLECTION WITH THE ABLATION CATHETER, IT IS THOUGHT THAT TOO MUCH FORCE WAS USED. ABLATION HAD JUST BEGUN AROUND THE LEFT VEINS WITH ANESTHESIA NOTED THAT THE PATIENT'S BLOOD PRESSURE BEGAN TO DROP. ICE REVEALED A PERICARDIAL EFFUSION, THE PERFORATION WAS LOCATED IN THE LEFT ATRIUM, POSSIBLY THE LEFT ATRIAL APPENDAGE. THE PATIENT IS STABLE. THE PHYSICIAN ALLEGES THAT USING TOO MUCH FORCE IN THE LEFT ATRIUM, POSSIBLY NEAR THE LEFT ATRIAL APPENDAGE CAUSED THE EFFUSION. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 21457879 ↗
• InjuryFeb 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT THE END OF A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, A TRANSESOPHAGEAL ULTRASOUND WAS DONE WHICH REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED AND 600 ML WAS DRAINED AND THE PATIENT STABILIZED. THE PERFORATION WAS LOCATED IN THE CORONARY SINUS AND THE PHYSICIAN BELIEVES IT OCCURRED DURING AN ABLATION SHOT IN THIS LOCATION. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 21374419 ↗
• InjuryJan 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING TRANSSEPTAL PROCEDURE FOR LEFT-SIDED ACCESSORY PATHWAY ABLATION, PATIENT BECAME UNRESPONSIVE TO VERBAL STIMULI. AFTER PATIENT ENGAGED STAFF VERBALLY IT WAS NOTED THAT PATIENT WAS "CLAMMY" TO THE TOUCH AND HIS COLOR HAD BECOME PALE. PHYSICIAN HALTED ABLATION PROCEDURE AT THAT TIME AND A STAT ECHOCARDIOGRAM WAS PERFORMED THAT VERIFIED PERICARDIAL EFFUSION. ABLATION PROCEDURE WAS ENDED AND A PERICARDIOCENTESIS WAS PERFORMED.

  Patient problems: Cardiac Perforation

  MAUDE report 21274942 ↗
• InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING AN ATRIAL FIBRILLATION PROCEDURE, AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT.

  Patient problems: Cardiac Perforation

  MAUDE report 21150431 ↗
• InjuryNov 26, 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 REQUIRING A PERICARDIOCENTESIS, TRANSFUSION, AND PROTAMINE TO STABILIZE THE PATIENT. DURING ABLATION, THE PATIENT BECAME HYPOTENSIVE AND WITH FLUOROSCOPY AND ULTRASOUND A TAMPONADE WAS NOTED IN THE LEFT ATRIUM. AFTER THE INTERVENTIONS WERE PERFORMED, THE PATIENT STABILIZED. THERE WERE NO ALLEGED ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 20785186 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A PREMATURE VENTRICULAR CONTRACTION PROCEDURE ON THE LEFT VENTRICLE, IN THE RECOVERY ROOM, A PERICARDIAL EFFUSION WAS FOUND. THE PATIENT BECAME HYPOTENSIVE THREE HOURS POST PROCEDURE AND AN ULTRASOUND CONFIRMED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED STABILIZING THE PATIENT. THE NEXT MORNING THE PERICARDIUM WAS STILL DRY, AND THE PATIENT REMAINED STABLE. THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES. IT IS UNKNOWN WHEN THE PERFORATION OCCURRED.

  Patient problems: Cardiac Perforation

  MAUDE report 20784180 ↗
• InjuryNov 5, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING AN ACCESSORY PATHWAY PROCEDURE, A STEAM POP OCCURRED FOLLOWED BY A TAMPONADE WHICH REQUIRED A PERICARDIOCENTESIS TO STABILIZE THE PATIENT. ABLATION WAS BEING PERFORMED IN THE ACCESSORY PATHWAY CLOSE TO THE CORONARY SINUS WHEN THE STEAM POP OCCURRED. ICE REVEALED A PERFORATION IN THE CS OSTIUM. NO REPORTS OF ABNORMAL PARAMETERS OR ANY MALFUNCTION WITH THE CATHETER.

  Patient problems: Cardiac Perforation

  MAUDE report 20606528 ↗
• DeathNov 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENTED WITH ACUTE CORONARY SYNDROME DURING THE ELECTROPHYSIOLOGICAL STUDY AND ABLATION PROCEDURE, EVOLVING WITH SUSTAINED VENTRICULAR TACHYCARDIA, VENTRICULAR FIBRILLATION, CARDIOGENIC SHOCK, CARDIORESPIRATORY ARREST AND EXPIRED.

  Patient problems: Arrhythmia; Cardiac Arrest; Cardiogenic Shock; Shock

  MAUDE report 20600165 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A PREMATURE VENTRICULAR CONTRACTION ABLATION PROCEDURE, AN ULTRASOUND REVEALED A PERICARDIAL EFFUSION REQUIRING A PERICARDIOCENTESIS. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 20267002 ↗
• InjurySep 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, AN ULTRASOUND REVEALED A PERICARDIAL EFFUSION IN THE LEFT ATRIUM, CLOSE TO THE LEFT VEINS REQUIRING A PERICARDIOCENTESIS AND SURGERY TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 20189706 ↗
• 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 19644392 ↗
• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATYPICAL ATRIAL FLUTTER IN THE LEFT ATRIUM, A CARDIAC TAMPONADE OCCURRED WHICH REQUIRED A PERICARDIOCENTESIS TO STABILIZE THE PATIENT. WHILE ABLATING, IT WAS OBSERVED THAT THE BLOOD PRESSURE DECREASED FROM 120-130 SYSTOLIC TO 50 SYSTOLIC. AN ULTRASOUND WAS DONE WHICH CONFIRMED A TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED AND 50CC OF BLOOD WAS DRAINED AND THE PATIENT STABILIZED. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 19622929 ↗
• InjuryMar 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT EXPERIENCED A DROP IN BLOOD PRESSURE DURING A VT ABLATION FROM A RETROGRADE AORTIC APPROACH. THE PATIENT HAD CABG SURGERY DAYS PRIOR TO THE ABLATION. THE DROP IN BLOOD PRESSURE RESOLVED AND THE PROCEDURE WAS CANCELLED. THERE WERE NO ALLEGED ISSUES WITH ANY ABBOTT DEVICES, HOWEVER, IT IS UNKNOWN WHAT CAUSED THE HYPOTENSION.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 18914475 ↗
• InjuryMar 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL TACHYCARDIA PROCEDURE, A PERICARDIAL EFFUSION REQUIRING PERICARDIOCENTESIS OCCURRED. DURING ABLATION, THE PATIENT BECAME HYPOTENSIVE, AND PHYSICIAN PERFORMED AN ULTRASOUND WHICH CONFIRMED A PERICARDIAL EFFUSION. THE LOCATION AND WHEN THE PERICARDIAL EFFUSION OCCURRED IS UNKNOWN. THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 18833963 ↗
• InjuryFeb 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE, A PERICARDIAL EFFUSION OCCURRED WHICH REQUIRED A PERICARDIOCENTESIS TO STABILIZE THE PATIENT. AFTER A FEW MINUTES OF MAPPING IN THE LEFT ATRIUM WITH THE ABLATION CATHETER, HYPOTENSION WAS OBSERVED. AN ECHOCARDIOGRAM WAS DONE WHICH CONFIRMED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED WHICH DRAINED 400ML TO STABILIZE THE PATIENT. THE PATIENT IS RECOVERING. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 18762875 ↗