TactiCath™ A-TCSE-FRecalls & reported problems

Summary

The FDA's MAUDE database contains 122 adverse event reports that list this exact device (DI 05415067027696), received between Jul 10, 2018 and Aug 19, 2026 — classified as 5 deaths, 86 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Fracture” (15 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 122 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2026Optical Problem

  During a Paroxysmal Atrial Fibrillation procedure, a delay of approximately 1 hour occurred when pressure readings were not displayed on the system. The TactiCath Catheter was exchanged; however, the issue persisted. Multiple system and equipment restarts were subsequently performed. Following an additional restart, pressure readings became available for both TactiCath Catheters, but the initial catheter continued to demonstrate intermittent pressure display readings. The procedure was completed without adverse patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50323355 ↗
• InjuryOct 15, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  FOLLOWING THE ATRIAL FIBRILLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED WHICH REQUIRED A PERICARDIOCENTESIS. PULMONARY VEIN ABLATION AND CTI WAS PERFORMED. A TRANSESOPHAGEAL ECHOCARDIOGRAM WAS NOT PERFORMED BECAUSE IT WAS NOT POSSIBLE TO INSERT THE PROBE INTO THE PATIENT'S MOUTH. THE TRANSESOPHAGEAL ECHO WAS NOT PERFORMED BECAUSE IT WAS IMPOSSIBLE TO INSERT THE PROBE INTO THE PATIENT'S MOUTH. THE PATIENT HAD A PATENT FORAMEN OVALE, THROUGH WHICH THE CATHETERS WERE INSERTED. WHILE ABLATING ON THE CTI, A STEAM POP WAS NOTED. A CARDIAC ULTRASOUND WAS DONE AT THE END OF THE PROCEDURE WHICH WAS NEGATIVE. TWO TO FOUR HOURS AFTER THE PROCEDURE, THE PATIENT'S BLOOD PRESSURE DECREASED. AN ECHOCARDIOGRAM WAS DONE WHICH REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED, 500ML WAS REMOVED AND THE PATIENT STABILIZED. THE PHYSICIAN THINKS THE EFFUSION IS DUE TO THE STEAM POP ON THE CTI.

  Patient problems: Cardiac Perforation

  MAUDE report 23304039 ↗
• InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT INCLUDES AN UPDATED EVENT DESCRIPTION AND UPDATED HEALTH CLINICAL CODE AND HEALTH IMPACT CODE. DURING AN ATRIAL FIBRILLATION PROCEDURE, WHILE MAPPING, AV BLOCK OCCURRED WHICH WAS TREATED WITH STIMULATION TO STABILIZE THE PATIENT. THE PATIENT WAS SEDATED WITH DEXDOR AND MAPPING WAS PERFORMED USING BOTH THE TACTICATH SE CATHETER AND THE ADVISOR FL SE CATHETER. TOWARDS THE END OF THE MAPPING THE PATIENT WENT INTO COMPLETE AV BLOCK WITH ST SEGMENT ELEVATION IN THE ABSENCE OF HEMODYNAMIC LESIONS ON CORONARY IMAGING. STIMULATION WAS ADMINISTERED IN THE CORONARY SINUS WITH THE CATHETER AND AFTER A FEW SECONDS SINUS RHYTHM WAS RESTORED. A CARDIOGRAM WAS DONE WHICH WAS NEGATIVE. THE PATIENT WAS UNABLE TO BE AWAKENED AND DEVELOPED A COMA, SO CT AND MRI EXAMS WERE DONE WHICH WERE NEGATIVE. THE PATIENT WAS ADMITTED TO ICU AND GRADUALLY RECOVERED CONSCIOUSNESS THE NEXT DAY. CT SCANS WERE REPEATED, AND AN ISCHEMIC ENCEPHALIC LESION APPEARED WITH CONCURRENT MOTOR DEFICIT OF THE UPPER LIMB. THE PHYSICIANS DO NOT THINK THAT ANY ABBOTT PRODUCTS ARE INVOLVED IN THE REPORTED EVENT. NO ABLATIONS HAD BEEN PERFORMED PRIOR TO THE REPORTED AV BLOCK. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABB

  Patient problems: Heart Block; Stroke/CVA

  MAUDE report 22197946 ↗
• InjuryMay 28, 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 A PERICARDIOCENTESIS. AFTER ABLATION BEGAN THE PATIENT BECAME HYPOTENSIVE. AN ECHOCARDIOGRAM WAS PERFORMED AND SHOWED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT STABILIZED. THE PHYSICIAN STATED THAT THE LEFT ATRIUM OF THE HEART WAS SICK WITH A LOT OF SCAR TISSUE AND THIN WALLS. THERE WERE NO HIGH PRESSURES NOTED DURING CATHETER USE HOWEVER THE PHYSICIAN ALLEGES THAT THE POSTERIOR OR ANTERIOR WALL WAS PERFORATED DURING MANEUVERING OF THE ABLATION CATHETER. THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 22095479 ↗
• InjuryMay 14, 2025Improper or Incorrect Procedure or Method; Optical Problem; Improper or Incorrect Procedure or Method; Optical Problem

  DURING AN ATRIOVENTRICULAR REENTRANT TACHYCARDIA PROCEDURE, THE LEFT VENTRICLE RUPTURED CAUSING A CARDIAC TAMPONADE REQUIRING A STERNOTOMY TO CONTROL THE BLEEDING. THE CATHETER WAS INTRODUCED THROUGH THE AORTA AND THE TACTICATH CATHETER WAS POSITIONED IN THE LATERAL ISTHMUS WITH AN AVERAGE OF 60-70 GRAMS OF FORCE. THE PHYSICIAN WAS ADVISED THAT THE CATHETER HAD TOO MANY GRAMS OF FORCE, BUT IT WAS ALLEGED THAT THE FORCE WAS HIGHER THAN WHAT WAS ACTUALLY OCCURRING. AFTER 1 SECOND OF RF, THE TACHYCARDIA STOPPED BUT ABLATION WAS CONTINUED FOR A MINUTE AND A HALF REACHING AN LSI OF 11.2. RIGHT AFTER THE PATIENT STARTED FEELING DIZZY AND WITH A HEAVY PRESSURE ON THEIR CHEST. AN ECHOCARDIOGRAM CONFIRMED THE LEFT VENTRICLE WAS RUPTURED WITH THE ABLATION CATHETER AND A CARDIAC TAMPONADE DEVELOPED. AN EMERGENCY STERNOTOMY WAS PERFORMED TO CONTROL THE BLEEDING. DURING REPARATIVE SURGERY, A HOLE WAS FOUND ON THE VENTRICULAR ASPECT OF THE MITRAL VALVE. IT WAS REPAIRED AND THE PATIENT IS AT THE ICU RECOVERING. THERE WERE NO ALLEGED ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 22019516 ↗
• InjuryMar 5, 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. HALF OF THE ANTERIOR LINE WAS ABLATED WHEN THE IMPEDANCE OF THE TACTICATH SE ROSE TO 200 OHMS. THE MEAN IMPEDANCE OF THE LEFT ATRIUM OF THE PATIENT WAS AROUND 110 OHMS. A FEW MINUTES AFTER, THE PATIENT BECAME HYPOTENSIVE. A TAMPONADE WAS FOUND WITH THE ECHOCARDIOGRAM. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT STABILIZED. THE PHYSICIAN ALLEGES THAT THE PERICARDIUM WAS PERFORATED WITH THE TACTICATH SE.

  Patient problems: Cardiac Perforation

  MAUDE report 21527516 ↗
• MalfunctionMar 4, 2025Optical Problem; Optical Problem

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, CONTACT FORCE WAS NOT DISPLAYED RESULTING IN A DELAY. THE TACTISYS QUARTZ WAS RESTARTED AND REPLACED, BUT THE ISSUE PERSISTED. THE TACTICATH CATHETER WAS REPLACED WITH ANOTHER OF THE SAME LOT, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21511858 ↗
• InjuryFeb 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE, MITRAL VALVE INSUFFICIENCY OCCURRED. WHILE IN THE LEFT VENTRICLE, A SUDDEN DROP IN BLOOD PRESSURE WAS OBSERVED. AN ECHOCARDIOGRAM WAS PERFORMED WHICH EXCLUDED PERICARDIAL EFFUSION. A TRANSESOPHAGEAL ECHOCARDIOGRAM WAS PERFORMED WHICH REVEALED MITRAL VALVE INSUFFICIENCY WITH AN UNKNOWN CAUSE. THE PROCEDURE WAS STOPPED AND THE PATIENT WAS TRANSFERRED TO THE ICU FOR CONTINUED MONITORING. THE ABLATION CATHETER WAS IN THE LEFT VENTRICLE WHEN THIS ISSUE OCCURRED. THE PHYSICIAN THINKS THE ABLATION PERFORMED DURING THIS PROCEDURE MAY HAVE CAUSED THE VALVE TO WORSEN, LEADING TO DILATION OF THE MITRAL RING. MITRAL VALVE CLIPS WERE PLACED AND THE PATIENT CONTINUES TO BE MONITORED IN THE ICU. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Low Blood Pressure/ Hypotension; Valvular Insufficiency/ Regurgitation

  MAUDE report 21471930 ↗
• MalfunctionFeb 21, 2025Fracture; Fracture

  THIS REPORT IS TO ADVISE OF A FRACTURE FOUND IN THE CATHETER DURING ANALYSIS EXPOSING INTERNAL WIRING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21433950 ↗
• MalfunctionJan 3, 2025Optical Problem; Optical Problem

  RELATED MANUFACTURING REFERENCE: 3008452825-2025-00004. DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, OPTICAL ISSUES RESULTED IN A PROCEDURAL DELAY. IT WAS NOTED THAT THE CATHETER PRESSURE COULD NOT BE DISPLAYED. THE CATHETER WAS REPLACED AND THE CATHETER PRESSURE WOULD ONLY DISPLAY INTERMITTENTLY. THE SECOND CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21066682 ↗
• MalfunctionJan 3, 2025Optical Problem; Optical Problem

  RELATED MANUFACTURING REFERENCE: 3008452825-2025-00005. DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, OPTICAL ISSUES RESULTED IN A PROCEDURAL DELAY. IT WAS NOTED THAT THE CATHETER PRESSURE COULD NOT BE DISPLAYED. THE CATHETER WAS REPLACED AND THE CATHETER PRESSURE WOULD ONLY DISPLAY INTERMITTENTLY. THE SECOND CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21066577 ↗
• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT INCLUDES UPDATED DEVICE INFORMATION.

  Patient problems: Cardiac Perforation

  MAUDE report 20901674 ↗
• InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING AN ATRIAL FIBRILLATION PROCEDURE, A PERICARDIAL EFFUSION WAS NOTED ON THE ECHOCARDIOGRAPHY REQUIRING PROTAMINE AND A PERICARDIOCENTESIS. THE PATIENT DID NOT HAVE ANY SYMPTOMS. IT IS UNKNOWN WHEN AND WHY THERE WAS A PERICARDIAL EFFUSION. FOLLOWING THE PERICARDIOCENTESIS, THE PATIENT STABILIZED. THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 20588085 ↗
• InjurySep 19, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING A REDO PULMONARY VEIN ISOLATION PROCEDURE, A STEAM POP FOLLOWED BY A PERICARDIAL EFFUSION OCCURRED WHICH REQUIRED A PERICARDIOCENTESIS TO STABILIZE THE PATIENT. USING ENSITE X WITH THE ABLATION CATHETER, AN ANTERIOR LINE THROUGH THE SCAR TISSUE OF THE LEFT ATRIUM WITH HPSD, A STEAM POP OCCURRED AT THE ANTERO-SEPTAL WALL. NO IMPEDANCE DROP ALERT WAS SHOWN. HYPOTENSION WAS NOTED. THE PROCEDURE WAS STOPPED AND A TRANSTHORACIC ECHOCARDIOGRAM WAS DONE WHICH DIAGNOSED A PERICARDIAL EFFUSION, A PERFORATION IN THE ANTERO-SEPTAL IN THE LEFT ATRIUM. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT STABILIZED.

  Patient problems: Cardiac Perforation

  MAUDE report 20255801 ↗
• MalfunctionSep 16, 2024Use of Device Problem; Communication or Transmission Problem; Use of Device Problem; Communication or Transmission Problem

  THIS REPORT INCLUDES CORRECTED DEVICE INFORMATION AND AN UPDATED MEDICAL DEVICE PROBLEM CODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20232611 ↗
• MalfunctionSep 10, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20185745 ↗
• InjuryAug 14, 2024Optical Problem; Optical 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 19988594 ↗
• InjuryJun 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIOVENTRICULAR REENTRANT TACHYCARDIA (AVRT) CASE, THE PATIENT SUFFERED VENTRICULAR FIBRILLATION (VF) WHICH REQUIRED CARDIOVERSION TO STABILIZE THE PATIENT. THE ARRHYTHMIA OCCURRED WHILE MAPPING THE MITRAL VALVE USING A RETROAORTIC APPROACH. THE PHYSICIAN STATES THAT HE DOESN¿T BELIEVE THAT THE CATHETER CAUSED OR CONTRIBUTED TO THE COMPLICATION. THERE WERE NO FURTHER COMPLICATIONS AND THE PATIENT IS STABLE AND HEALTHY. THE CAUSE OF THE VF IS UNKNOWN.

  Patient problems: Ventricular Fibrillation

  MAUDE report 19466653 ↗
• MalfunctionApr 1, 2024Optical Problem; Optical Problem

  DURING A PREMATURE VENTRICULAR CONTRACTION PROCEDURE, A CONTACT FORCE ERROR WAS NOTED CAUSING A DELAY. ONCE THE CATHETER WAS PLACED IN THE SHEATH TO GET TO THE LEFT VENTRICULAR OUTFLOW TRACT, THE ENSITE MAPPING SYSTEM DISPLAYED AN ERROR MESSAGE STATING: "NO CONTACT FORCE INFORMATION AVAILABLE". THE CONTACT FORCE DISPLAYED NORMALLY WHEN THE CATHETER WAS PLACED IN THE RIGHT VENTRICULAR OUTFLOW TRACT. CONNECTIONS WERE CHECKED AND THE TACTISYS AND THE MAPPING SYSTEM WERE RESTARTED WITH NO RESOLUTION. THE CATHETER WAS EXCHANGED, AND THE PROCEDURE WAS COMPLETED WITHOUT ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19011170 ↗
• DeathMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT 3 WEEKS FOLLOWING A PERSISTENT ATRIAL FIBRILLATION ABLATION PROCEDURE, THE PATIENT DEVELOPED AN ATRIOESOPHAGEAL FISTULA AND DIED. DURING THE PROCEDURE, WHICH WAS DONE AFTER A FORMER PULMONARY VEIN ISOLATION PROCEDURE, THE PHYSICIAN REPORTS A DIFFICULT TRANSSEPTAL PUNCTURE DURING THE PROCEDURE. A PERICARDIAL EFFUSION WAS SUSPECTED SO THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) PROBE WAS USED THROUGHOUT THE PROCEDURE TO CONTINUALLY MONITOR FOR AN EFFUSION. THE PULMONARY VEINS WERE ISOLATED AND THE PHYSICIAN DECIDED TO MAKE AN ISOLATION OF THE POSTERIOR BOX AND AN ANTERIOR MITRAL LINE FROM THE MITRAL ANNULUS TO THE RIGHT PULMONARY SUPERIOR VEIN. IT WAS NOT POSSIBLE TO USE THE ESOPHAGEAL TEMPERATURE MONITORING PROBE BECAUSE OF THE PRESENCE OF THE TEE PROBE DURING THE ENTIRE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO EFFUSION BEING DETECTED. A THORACIC SCAN WAS PERFORMED LATER THAT DAY WHICH WAS ALSO NEGATIVE FOR ANY EFFUSION. THREE WEEKS POST-PROCEDURE, THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM FOR BLOODY VOMITING AND FEVER. A GASTROSCOPY WAS REQUESTED WITHOUT USING AIR INSUFFLATIONS BUT CO2. THE GASTROSCOPY SHOWED A PERFORATION IN THE ESOPHAGUS THAT COULD BE

  Patient problems: Perforation of Esophagus

  MAUDE report 18977629 ↗
• InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT THE END OF AN ATYPICAL FLUTTER PROCEDURE, AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 18902812 ↗
• InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SIX DAYS POST PROCEDURE, AN MRI CONFIRMED THE PATIENT EXPERIENCED A STROKE ON THE LEFT SIDE WHICH REQUIRED PROLONGED HOSPITALIZATION; NO TREATMENT WAS ADMINISTERED. THERE WAS NOTHING DURING THE ABLATION PROCEDURE THAT WAS NOT AS EXPECTED AND THERE WERE NO PERFORMANCE ISSUES WITH ANY OF THE ABBOTT DEVICES INVOLVED.

  Patient problems: Stroke/CVA

  MAUDE report 18873607 ↗
• DeathFeb 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT INCLUDES UPDATED DEVICE INFORMATION.

  Patient problems: Endocarditis; Perforation of Esophagus

  MAUDE report 18799168 ↗
• MalfunctionFeb 2, 2024Signal Artifact/Noise; Signal Artifact/Noise

  DURING THE SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, NOISE ISSUES WITH THE CATHETER RESULTED IN A PROCEDURAL DELAY. THE CATHETER WAS PROPERLY REMOVED FROM THE PACKAGING AND DEFLECTED AS INTENDED. THE CATHETER WAS THEN INSERTED THROUGH AN SL1 INTRODUCER INTO THE RIGHT ATRIUM, BUT THE FIRST ELECTRODE FAILED TO DISPLAY THE ELECTRIC POTENTIAL. THE AMPLIFIER, THE DWS, THE AMPERE AND THE TACTISYS WERE ALL RESTARTED BUT THE ISSUE WAS NOT RESOLVED. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18634073 ↗
• InjuryJan 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING AN ATRIAL FIBRILLATION PROCEDURE, A PERICARDIAL EFFUSION WAS NOTED THAT REQUIRED A PERICARDIOCENTESIS. IN THE WARD, THE PATIENT BECAME HYPOTENSIVE. AN ECHOCARDIOGRAM REVEALED THE PERICARDIAL EFFUSION. PE PUNCTURE REMOVED 370ML BLOOD FROM THE PERICARDIUM AND IT WAS CONFIRMED THE EFFUSION WAS CLEARED ON THE ECHOCARDIOGRAM. THE PATIENT STABILIZED AND RETURNED TO THE CCU FOR MONITORING. IT WAS POSSIBLE THE PUNCTURE WAS CAUSED BY THE TACTICATH SE ABLATION CATHETER BECAUSE THE PHYSICIAN HAD DIFFICULTY CANNULATING THE LEFT PULMONARY VEINS AND HIGH-PRESSURE READINGS WERE SEEN. THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES, AND IT IS UNKNOWN WHEN THE PERFORATION OCCURRED.

  Patient problems: Cardiac Perforation

  MAUDE report 18560353 ↗