FlexAbility™ A-FASE-DFRecalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 05415067020062), received between Jun 15, 2018 and Feb 11, 2026 — classified as 6 deaths, 43 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 65 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION PROCEDURE IN THE LEFT ATRIUM, THE ROOF WAS PUNCTURED RESULTING IN A PERICARDIOCENTESIS BEING PERFORMED. AN ECHOCARDIOGRAM WAS PERFORMED AND CONFIRMED THE PUNCTURE. THE BLOOD WAS DRAINED FROM THE PERICARDIAL SAC. THE PATIENT WAS STABLE AT THE END OF THE PROCEDURE. THE PHYSICIAN ALLEGES THE ABLATION CATHETER AS THE CAUSE FOR THE CARDIAC PERFORATION. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 24319176 ↗
• MalfunctionJan 8, 2026Obstruction of Flow

  DURING A PREMATURE VENTRICULAR CONTRACTION PROCEDURE, THERE WAS A FLOW ISSUE WITH THE CATHETER RESULTING IN A DELAY. THE SYSTEM ISSUED A WARNING AND STOPPED ABLATION WHEN THE FLOW RATE INCREASED FROM 2ML/MIN TO 17ML/MIN. CONNECTIONS WERE CHECKED, THE PUMP AND CABLES WERE REPLACED, AND THE CATHETER WAS FLUSHED, BUT THE ISSUE REMAINED. THE CATHETER WAS THEN REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24005616 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT THE END OF A WPW PROCEDURE IN THE RA WITH THE ENSITE X SYSTEM AND THE FLEXABILITY ABLATION CATHETER, THE PATIENT EXPERIENCED AN ST ELEVATION. A CORONARY ANGIOGRAPHY WAS PERFORMED AND A STENT WAS IMPLANTED DUE TO AN OCCLUSION OF THE POSTEROLATERAL RCA. THE PHYSICIAN IS UNSURE OF THE EXACT CAUSE OF THE ST ELEVATION, POTENTIALLY THERMAL TRAUMA OF THE RF ENERGY NEAR THE CORONARY SINUS. THE PHYSICIAN STATED THERE WAS NO MALFUNCTION OF THE CATHETER. THE PATIENT IS IN STABLE CONDITION.

  Patient problems: Arrhythmia

  MAUDE report 23796308 ↗
• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WHEN ATTEMPTING TO CONVERT TO THE ABLATION CATHETER, THE ABLATION CATHETER COULD NOT BE ADVANCED INTO THE DESCENDING AORTA. INITIALLY, AN ATTEMPT TO EXCHANGE A LONG SHEATH OVER A LONG WIRE WAS DONE BUT THE WIRE COULD NOT BE ADVANCED. CONTRAST INJECTION WAS DONE SHOWING A RETROGRADE DISSECTION WITHOUT ANY CONTRAST EXTRAVASATION. FURTHER ATTEMPTS TO ADVANCE WERE DEFERRED AND CONVERTED TO A TRANSSEPTAL APPROACH. NO TREATMENT, RESOLVED WITHOUT SEQUELA. "AE REL TO ADDITIONAL DEVICE: NOT RELATED AE REL TO DEVICE UNDER STUDY: AE REL TO IMPLANT PROCEDURE: AE RELATED TO COVID: NOT RELATED EVENT DESCRIPTION: OTHER EVENT DESCRIPTION- OTHER, SPEC: RETROGRADE DISSECTION. AE EVENT DETAILS: WHEN ATTEMPTING TO CONVERT TO THE ABLATION CATHETER BUT WAS UNABLE TO ADVANCE THE ABLATION CATHETER INTO THE DESCENDING AORTA. INITIALLY ATTEMPTED TO EXCHANGE FOR A LONG SHEATH OVER A LONG WIRE BUT COULD NO ADVANCE WIRE. A CONTRAST INJECTION WAS DONE SHOWING A RETROGRADE DISSECTION WITHOUT ANY CONTRAST EXTRACASATION. GIVEN FINDING, FURTHER ATTEMPTS TO ADVANCE WERE DEFERRED AND CONVERTED TO A TRANSSEPTAL APPROACH. CLINICAL STUDY NAME: CRD_1054 - ABBOTT VT PAS STUDY. CLINICAL STUDY PATIENT ID: (B)(6), PATIENT NU

  Patient problems: Vascular Dissection

  MAUDE report 21943705 ↗
• MalfunctionMar 4, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21515638 ↗
• MalfunctionJan 8, 2025Signal Artifact/Noise; Signal Artifact/Noise

  DURING THE PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, SIGNAL ISSUES RESULTED IN A PROCEDURAL DELAY. THE ENSITEX WAS STARTED AND THE CATHETER WAS CONNECTED. THE CATHETER WAS RECOGNIZED BY ENSITE HOWEVER, NOISE WAS NOTED ON ELECTRODES 1-2 AND THE POTENTIALS COULD NOT BE SEEN. THE CATHETER WAS RECONNECTED AND THE ENSITE X SYSTEM WAS RESTARTED, WITH NO RESOLUTION. THE CATHETER WAS EXCHANGED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21105833 ↗
• MalfunctionJul 2, 2024Signal Artifact/Noise; Signal Artifact/Noise

  DURING A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, A NOISE ISSUE ON THE CATHETER RESULTED IN A DELAY TO THE PROCEDURE. WHEN THE CATHETER ENTERED THE RIGHT ATRIUM, IT WAS NOTED THAT THERE WAS INTERFERENCE WITH THE 1-2 ELECTRODE SIGNAL, AND THE CATHETER DISPLAYED NORMAL. THE BASELINE SIGNAL FLUCTUATION WAS TOO LARGE, AFFECTING POTENTIAL RECOGNITION. THE DISPLAY WORKSTATION AND AMPERE WERE RESTARTED BUT WITH NO RESOLUTION. THE CATHETER WAS REPLACED, AND THE POTENTIAL DISPLAYED NORMAL RESOLVING THE ISSUE. THE PROCEDURE PROCEEDED NORMALLY WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19656774 ↗
• MalfunctionJun 19, 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 19568103 ↗
• InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING AN INDEX PROCEDURE THAT TOOK PLACE ON (B)(6) 2024, A THROMBUS AND PERICARDIAL EFFUSION WAS FOUND REQUIRING DIURETIC MEDICATION AND A PERICARDIOCENTESIS. THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2024, HYPOTENSIVE WITH RECURRENT EPISODES OF VENTRICULAR TACHYCARDIA AND WAS STARTED ON LIDOCAINE. ON (B)(6) 2024, A TRANSTHORACIC ECHOCARDIOGRAM REVEALED A LEFT VENTRICULAR THROMBUS. LIDOCAINE WAS STOPPED AND HEPARIN WAS STARTED. THE PATIENT WAS DIURESED WITH PO TORSEMIDE 40MG DAILY AND TRANSFERRED TO ANOTHER HOSPITAL ON (B)(6) 2024. AN ECHOCARDIOGRAM OBTAINED ON (B)(6) 2024, SHOWED NOTABLE EF 15-25% WITH NO LEFT VENTRICULAR APICAL THROMBUS, RVSP 40-45 WITH A LARGE CIRCUMFERENTIAL PERICARDIAL EFFUSION CONCERNING FOR EARLY TAMPONADE PHYSIOLOGY. GIVEN NO EVIDENCE OF RECURRENT THROMBUS, THE HEPARIN DRIP WAS STOPPED. ON (B)(6) 2024, THE PATIENT UNDERWENT PERICARDIOCENTESIS WITH 1400 MILLILITERS OF SEROSANGUINEOUS FLUID REMOVED AND A PERICARDIAL DRAIN WAS PLACED. A TRANSTHORACIC ECHOCARDIOGRAM HAD NOT BEEN PERFORMED AFTER THE INDEX PROCEDURE. THERE WERE NO ALLEGED ISSUES WITH ANY ABBOTT DEVICES. THE PATIENT IS STABLE. THE PHYSICIAN ALLEGES THAT THE PERICARDIAL EFFUSION WAS A REAC

  Patient problems: Cardiac Perforation; Thrombosis/Thrombus

  MAUDE report 19515293 ↗
• MalfunctionMay 10, 2024Fracture; Fracture

  THIS REPORT IS TO ADVISE OF A FRACTURE FOUND IN THE CATHETER SHAFT DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19293985 ↗
• InjuryMar 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS PUBLISHED IN THEEUROPEAN HEART JOURNAL - CASE REPORTS 8.2 OXFORD UNIVERSITY PRESS. (FEB 1, 2024) IN AN ARTICLE TITLED "SUCCESSFUL ABLATION OF PURKINJE ECTOPY¿TRIGGERED VENTRICULAR FIBRILLATION STORM IN A PATIENT WITH ORTHOTOPIC HEART TRANSPLANTATION AND SEVERE SARS-COV-2 PNEUMONIA: A CASE REPORT"; M. K H A LA P H E T A L ET AL. THE PATIENT EXPERIENCED HEART BLOCK. A 41-YEAR-OLD MAN WITH AN ORTHOTOPIC HEART TRANSPLANTATION (HTX) IN 2014 DUE TO NON-ISCHEMIC DILATED CARDIOMYOPATHY, RECENTLY DIAGNOSED WITH AND TREATED FOR SARS-COV-2 PNEUMONIA, WAS REFERRED TO OUR CENTRE (SEE SUPPLEMENTARY MATERIAL ONLINE, FIGURE S1). THE PATIENT HAD EXPERIENCED VF STORM REQUIRING PROLONGED CARDIOPULMONARY RESUSCITATION (CPR) FOR 50 MIN AND >20 EXTERNAL DEFIBRILLATIONS WITHIN 24 H. DESPITE ADMINISTRATION OF ANTIARRHYTHMIC DRUGS (AMIODARONE), SEDATION WITH PROPOFOL AND MECHANICAL RESPIRATION FINALLY LED TO STABILIZATION OF THE RHYTHM. UPON ADMISSION TO OUR CENTRE, THE PATIENT EXPERIENCED ANOTHER VF STORM EPISODE, REQUIRING CPR AND ANOTHER 11 DEFIBRILLATIONS. DESPITE OUR BEST EFFORTS, THE VF EPISODES DID NOT RESPOND TO THE MEASURES TAKEN, WHICH INVOLVED SUBSTITUTION OF ELECTROLYTES (POTA

  Patient problems: Heart Block

  MAUDE report 18913382 ↗
• InjuryMar 12, 2024Device Contamination with Body Fluid; Device Contamination with Body Fluid

  FOLLOW UP REPORT NEEDED TO INCLUDE UPDATED DEVICE INFORMATION.

  Patient problems: Stroke/CVA

  MAUDE report 18891573 ↗
• InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIOVENTRICULAR NODAL REENTRY TACHYCARDIA PROCEDURE, IT WAS NOTED THAT THERE WAS A DISSOCIATION BETWEEN SIGNALS A AND V AFTER ABLATION. AFTER 10 SECONDS IT WAS THEN NOTED THAT THE PATIENT WAS SINUSAL AND CONDUCTION THROUGH THE AV NODE WAS NOT OBSERVED EVEN WITH PACING MANEUVERS. THE AV BLOCK WAS NOT A CATHETER ISSUE, SO THE DEVICE WAS NOT REPLACED. THE PHYSICIAN DECIDED TO STOP THE CASE BECAUSE OF THE AV BLOCK.

  Patient problems: Heart Block

  MAUDE report 18325759 ↗
• InjurySep 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED WHICH WAS CONFIRMED WITH AN ECHOCARDIOGRAM AND REQUIRED A PERICARDIOCENTESIS FOLLOWED BY SURGERY TO STABILIZE THE PATIENT. DURING THE PROCEDURE, ALL 4 PULMONARY VEIN ISOLATIONS WERE COMPLETED AND THE PHYSICIAN WAS ATTEMPTING TO POSITION THE CATHETER TO THE ANTERIOR RIGHT INFERIOR PULMONARY VEIN WHEN A DECREASE IN BLOOD PRESSURE WAS NOTED. THE PROCEDURE WAS STOPPED AND AN ECHOCARDIOGRAM WAS DONE TO DIAGNOSE THE PERICARDIAL EFFUSION, A PERFORATION LOCATED ON THE ROOF OF THE LEFT ATRIUM. A PERICARDIOCENTESIS WAS PERFORMED AND OVER 1100ML FLUID WAS DRAINED BUT IT DID NOT RESOLVE. THE PATIENT WAS TRANSFERRED TO THEATER FOR SURGERY. THE PHYSICIAN BELIEVES THE PERFORATION HAPPENED DURING CATHETER MANIPULATION. THE PATIENT IS IN THE INTENSIVE CARE UNIT AND IS STABLE. THERE ARE NO REPORTED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 17700086 ↗
• InjuryJul 20, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  A BLOOD CLOT WAS NOTED ON THE CATHETER TIP. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

  MAUDE report 17360648 ↗
• InjuryJun 16, 2023Entrapment of Device; Entrapment of Device

  THE PATIENT WAS DOING WELL POST SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 17143958 ↗
• MalfunctionApr 25, 2023Communication or Transmission Problem; Communication or Transmission Problem

  DURING THE PREMATURE VENTRICULAR CONTRACTION PROCEDURE, COMMUNICATION ISSUES WITH THE CATHETER AND THE ENSITE PRECISION CAUSED PROCEDURAL DELAYS. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. WHEN THE CATHETER WAS INSERTED INTO THE HEART AND CONNECTED TO AN EXTENSION CABLE, THE SE SENSOR WAS NOT RECOGNIZED BY ENSITE PRECISION. THE CABLES WERE CHANGED, THE INPUT PORTS WERE CHANGED, THE ENSITE PRECISION MODULE AND ENSITE WERE RESTARTED, BUT THE ISSUE PERSISTED. 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 16807002 ↗
• MalfunctionFeb 28, 2023Impedance Problem; Impedance Problem

  RELATED MANUFACTURING REFERENCE: 3008452825-2023-00050 AND 2182269-2023-00006. DURING THE AFL PROCEDURE, WHILE USING ENSITE X IN NAVX, IMPEDANCE AND DISPLAY ISSUES WERE NOTED WHICH CAUSED DELAYS TO TREATMENT. THE PROCEDURE WAS COMPLETED USING A NON-ABBOTT CATHETER (BLAZER 8MM) AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. DURING THE PROCEDURE, IT WAS NOTED AFTER 15 SECONDS OF ABLATING AT 30W THAT THE IMPEDANCE SPIKED TO 532 AND THEN TO 999 OHMS AND THAT THE CATHETER APPEARED DISTORTED AND TURNED RED ON THE SYSTEM. THE FOLLOWING TROUBLESHOOTING WAS DONE WITH NO RESOLUTION: CHECKING THE PHYSICAL CONNECTION BETWEEN THE GROUNDING PADS AND PATIENT'S BODY, CHECKING THAT THE GROUNDS WERE STILL PLUGGED INTO THE AMPERE GENERATOR, REPLACING THE FLEXABILITY SE CABLE, REPLACING THE FLEXABILITY SE CATHETER, REPLACING THE FLEXABILITY CATHETER, REPLACING THE SAFIRE CATHETER, REPLACING THE GENERATOR, REPLACING THE POWER CABLE AND PLUGGING DIRECTLY INTO THE HOSPITAL GROUNDED PLUG RECEPTACLE, POWER CYCLING BOTH AMPERE GENERATORS, RECONNECTING THE GROUNDING PAD CABLES FROM BOTH GENERATORS., PUTTING A NEW NON-ABBOTT GROUNDING PAD (MACROLYTE) IN A NEW LOCATION, PUTTING A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16453886 ↗
• MalfunctionFeb 28, 2023Impedance Problem; Impedance Problem

  RELATED MANUFACTURING REFERENCE: 3008452825-2023-00049 AND 2182269-2023-00006. DURING THE AFL PROCEDURE, WHILE USING ENSITE X IN NAVX, IMPEDANCE AND DISPLAY ISSUES WERE NOTED WHICH CAUSED DELAYS TO TREATMENT. THE PROCEDURE WAS COMPLETED USING A NON-ABBOTT CATHETER (BLAZER 8MM) AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. DURING THE PROCEDURE, IT WAS NOTED AFTER 15 SECONDS OF ABLATING AT 30W THAT THE IMPEDANCE SPIKED TO 532 AND THEN TO 999 OHMS AND THAT THE CATHETER APPEARED DISTORTED AND TURNED RED ON THE SYSTEM. THE FOLLOWING TROUBLESHOOTING WAS DONE WITH NO RESOLUTION: CHECKING THE PHYSICAL CONNECTION BETWEEN THE GROUNDING PADS AND PATIENT'S BODY, CHECKING THAT THE GROUNDS WERE STILL PLUGGED INTO THE AMPERE GENERATOR, REPLACING THE FLEXABILITY SE CABLE, REPLACING THE FLEXABILITY SE CATHETER, REPLACING THE FLEXABILITY CATHETER, REPLACING THE SAFIRE CATHETER, REPLACING THE GENERATOR, REPLACING THE POWER CABLE AND PLUGGING DIRECTLY INTO THE HOSPITAL GROUNDED PLUG RECEPTACLE, POWER CYCLING BOTH AMPERE GENERATORS, RECONNECTING THE GROUNDING PAD CABLES FROM BOTH GENERATORS., PUTTING A NEW NON-ABBOTT GROUNDING PAD (MACROLYTE) IN A NEW LOCATION, PUTTING A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16453859 ↗
• DeathJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A VENTRICULAR TACHYCARDIA PROCEDURE, THE PATIENT WENT INTO VENTRICULAR FIBRILLATION AT THE END OF THE PROCEDURE AND COULD NOT BE BROUGHT BACK TO SINUS RHYTHM. CARDIOVERSION WAS ATTEMPTED, AS WELL AS AN EXTERNAL DEFIBRILLATOR WITHOUT SUCCESS AND THE PATIENT EXPIRED. THE CAUSE OF DEATH IS UNKNOWN. THERE WERE NO PERFORMANCE ISSUES WITH ABBOTT DEVICES.

  Patient problems: Arrhythmia

  MAUDE report 16215132 ↗
• MalfunctionNov 16, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  DURING THE PREMATURE VENTRICULAR CONTRACTION PROCEDURE, ELECTRODES 3-4 APPEARED TO FOLD IN 3D AND A DELAY OCCURRED. THE SYSTEMS WERE RESTARTED WHICH DID NOT RESOLVE THE ISSUE. ANOTHER ABLATION CATHETER WAS USED TO COMPLETE PROCEDURE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15804765 ↗
• MalfunctionJul 27, 2022Therapeutic or Diagnostic Output Failure

  ABLATION CATHETER INSERTED INTO PATIENT BUT WAS UNABLE TO CONNECT WITH THE SYSTEM. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15111838 ↗
• MalfunctionJun 16, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE FOR ATRIAL TACHYCARDIA, THE ABLATION CATHETER WAS NOT ABLE TO BE VISUALIZED ON THE SYSTEM. THE TACHYCARDIA COULD NOT BE RE INDUCED, AND THE PROCEDURE WAS CANCELLED. THE PATIENT IS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14710483 ↗
• MalfunctionJun 6, 2022Fracture; Fracture

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING A FRACTURED CATHETER SHAFT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14611185 ↗
• InjuryApr 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PREMATURE VENTRICULAR CONTRACTIONS ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. DURING THE PROCEDURE THE ABLATION CATHETER HAD A MOMENT OF LOW IMPEDANCE AND SUSPECTED OF PERFORATION IN THE LEFT VENTRICLE. DURING ABLATION THE IMPEDANCE ROSE TO 150 OHMS AFTER 60 SECONDS OF LESION FORMATION AND THE PATIENT BECAME HYPOTENSIVE 12-15 MINUTES POST ABLATION. AN ECHOCARDIOGRAM WAS PERFORMED WHICH REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED WHICH STABILIZED THE PATIENT. THERE WAS NO PERFORMANCE ISSUES NOTED ON THE ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 14186752 ↗