FlexAbility™ A-FASE-DRecalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 05415067020031), received between Dec 13, 2018 and Jul 30, 2025 — classified as 4 deaths, 24 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (2 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 33 reports, in the reporter's own words as published by the FDA.

• DeathJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PREMATURE VENTRICULAR CONTRACTION ABLATION PROCEDURE, A TAMPONADE OCCURRED WHICH REQUIRED A PERICARDIOCENTESIS AND SURGERY. WHEN THE REGION OF INTEREST WAS ASSESSED, A FEW APPLICATIONS WERE DONE AT 40 WATTS AND THE PATIENT EXPERIENCED CARDIOGENIC SHOCK. FLUOROSCOPY AND ECHOCARDIOGRAM WERE PERFORMED WHICH REVEALED A TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED FOLLOWED BY SURGERY TO RESOLVE THE BLEEDING. THE PATIENT IS IN INTENSIVE CARE AND ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 22663883 ↗
• MalfunctionAug 14, 2024Signal Artifact/Noise; Display or Visual Feedback Problem; Signal Artifact/Noise; Display or Visual Feedback Problem

  DURING AN ATRIOVENTRICULAR NODE REENTRY TACHYCARDIA PROCEDURE, THERE WERE DISPLAY AND NOISE ISSUES ON THE CATHETER RESULTING IN A DELAY TO THE PROCEDURE. AFTER THE CATHETER WAS CONNECTED TO THE SYSTEM AND INSERTED INTO THE PATIENT, IT WAS NOTED THAT THE SHAPE OF THE CATHETER DISPLAYED ABNORMAL IN THE THREE-DIMENSIONAL SYSTEM AND THERE WAS NO POTENTIAL AT ELECTRODE 1 AND ELECTRODE 2. THE CONNECTION LINE WAS CHECKED, THE RADIOFREQUENCY INSTRUMENT WAS RESTARTED, AND THE SYSTEM WAS RESTARTED, BUT WITH NO RESOLUTION. 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 19983542 ↗
• MalfunctionAug 6, 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 19925384 ↗
• MalfunctionJun 17, 2024Material Deformation; Material Deformation

  THIS REPORT IS TO ADVISE OF A DISPLACED ELECTRODE AND EXPOSED INTERNAL CONDUCTOR WIRE BEING FOUND ON THE CATHETER DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19547458 ↗
• MalfunctionDec 6, 2022Temperature Problem; Temperature Problem

  RELATED MANUFACTURING REF: (B)(4). DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THERE WERE COMMUNICATION AND TEMPERATURE ISSUES WITH TWO FLEXABILITY CATHETERS, AND PERFORMANCE ISSUES WITH THE ENSITE X SYSTEM, RESULTING IN A DELAY OF PROCEDURE. AT FIRST NAVX WAS BEING USED, HOWEVER THE PATIENT HAD A FAT FROM THE CRISTA TERMINALIS. THEREFORE, THE MODE WAS SWITCHED TO VOXEL. THE FLEXABILITY SE BEING USED WAS SWITCHED TO A TACTIFLEX DUE TO TECHNICAL ISSUES AND USED FOR MAPPING IN VOXEL MODE, WHILE USING THE SUPREME AND CS CATHETER FOR MAPPING IN NAVX MODE. THE FOLLOWING ISSUES OCCURRED WITH THE ENSITE X SYSTEM: 1. THERE WERE ISSUES WITH FIELD SCALING IN NAVX MODE. NAVX FIELD SCALING AND SE FIELD SCALING WERE ATTEMPTED, BUT NEITHER WORKED CORRECTLY. A LOT OF POINTS WERE DELETED, WHICH MIGHT HAVE BEEN RELATED TO POINT COLLECTION IN THE SHEATH. 2. IT WAS DESIRED TO USE THE FLEXABILITY SE CATHETER FOR MAPPING IN NAVX MODE, WHEN IT WAS NOTICED THAT THE PATIENT HAD A FAT. THE FLEXABILITY SE CATHETER NEVER BECAME A GREEN ICON AND SHOWED POOR SENSOR QUALITY. THE CABLE WAS REPLACED, WHICH DID NOT HELP. THE FLEXABILITY SE CATHETER WAS THEN CHANGED TO A NEW FLEXABILITY SE CATHETER, WHERE THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15925663 ↗
• MalfunctionDec 6, 2022Communication or Transmission Problem; Communication or Transmission Problem

  RELATED MANUFACTURING REF: 2184149-2022-00287, 3008452825-2022-00717. DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THERE WERE COMMUNICATION AND TEMPERATURE ISSUES WITH TWO FLEXABILITY CATHETERS, AND PERFORMANCE ISSUES WITH THE ENSITE X SYSTEM, RESULTING IN A DELAY OF PROCEDURE. AT FIRST NAVX WAS BEING USED, HOWEVER THE PATIENT HAD A FAT FROM THE CRISTA TERMINALIS. THEREFORE, THE MODE WAS SWITCHED TO VOXEL. THE FLEXABILITY SE BEING USED WAS SWITCHED TO A TACTIFLEX DUE TO TECHNICAL ISSUES AND USED FOR MAPPING IN VOXEL MODE, WHILE USING THE SUPREME AND CS CATHETER FOR MAPPING IN NAVX MODE. THE FOLLOWING ISSUES OCCURRED WITH THE ENSITE X SYSTEM: 1. THERE WERE ISSUES WITH FIELD SCALING IN NAVX MODE. NAVX FIELD SCALING AND SE FIELD SCALING WERE ATTEMPTED, BUT NEITHER WORKED CORRECTLY. A LOT OF POINTS WERE DELETED, WHICH MIGHT HAVE BEEN RELATED TO POINT COLLECTION IN THE SHEATH. 2. IT WAS DESIRED TO USE THE FLEXABILITY SE CATHETER FOR MAPPING IN NAVX MODE, WHEN IT WAS NOTICED THAT THE PATIENT HAD A FAT. THE FLEXABILITY SE CATHETER NEVER BECAME A GREEN ICON AND SHOWED POOR SENSOR QUALITY. THE CABLE WAS REPLACED, WHICH DID NOT HELP. THE FLEXABILITY SE CATHETER WAS THEN CHANGED TO A NEW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15925654 ↗
• InjuryNov 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT THE END OF A PULMONARY VEIN ISOLATION PROCEDURE, THE PATIENT EXPERIENCED A PERICARDIAL TAMPONADE. AFTER TRANSSEPTAL ACCESS TO LEFT ATRIUM THE LEFT PULMONARY VEINS WERE ABLATED AND THEN THE RIGHT PULMONARY VEINS. THE PATIENT'S BLOOD PRESSURE DROPPED AND AN ECHO WAS DONE CONFIRMING THE TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT STABILIZED. THERE WAS NO ALLEGED ISSUE WITH THE ABBOTT DEVICE.

  Patient problems: Cardiac Perforation; Cardiac Tamponade

  MAUDE report 15863729 ↗
• DeathNov 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING AN ABLATION PROCEDURE, AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION AND THE PATIENT LATER EXPIRED. ABLATION OCCURRED ON (B)(6) 2022 WITH NO COMPLICATIONS NOTED. ON (B)(6) 2022, AN EFFUSION WAS NOTED WHICH REMAINED STABLE THROUGH PERIODIC ASSESSMENTS WITH NO ACTION REQUIRED. ON (B)(6) 2022 THE PATIENT EXPERIENCED A CARDIAC ARREST WITH ELECTRO-MECHANICAL DISSOCIATION. RESUSCITATION MANEUVERS WERE ATTEMPTED FOR 50 MINUTES UNSUCCESSFULLY, AND THE PATIENT EXPIRED. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES. PER THE PHYSICIAN, THE PATIENT EXPIRED DUE TO NON-CARDIOVASCULAR REASONS. NOT DUE TO THE PROCEDURE, EFFUSION OR ANY OTHER CARDIOVASCULAR REASONS.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 15804117 ↗
• InjuryMar 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED IN THE LEFT ATRIUM. THE PATIENT BECAME HYPOTENSIVE AND AN ECHOGRAM CONFIRMED THE EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED WHICH STABILIZED THE PATIENT.

  Patient problems: Cardiac Perforation

  MAUDE report 13952850 ↗
• InjuryDec 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ONE DAY FOLLOWING A VENTRICULAR TACHYCARDIA (VT) ABLATION PROCEDURE, THE PATIENT EXPERIENCED A PERICARDIAL DETACHMENT. A PERICARDIAL DETACHMENT WAS OBSERVED VIA ECHOCARDIOGRAPHY WITH NO EFFECT ON THE PATIENT'S HEALTH. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES. THE EVENT RESOLVED THE FOLLOWING DAY WITH NO INTERVENTION PERFORMED. IT WAS THOUGHT THAT THE PERICARDIAL DETACHMENT WAS CAUSED BY THE RADIO-FREQUENCY HEATING AND IS AN ANTICIPATED EVENT THAT OCCURS AT VENTRICULAR ABLATION PROCEDURES.

  Patient problems: Cardiac Perforation

  MAUDE report 12953382 ↗
• InjurySep 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE, THE PATIENT EXPERIENCED TRANSIENT ISCHEMIC ATTACK (TIA). A HEAD CT SCAN PERFORMED ON (B)(6) 2021 A MINUTE HYPODENSITY CONSISTENT WITH A TIA. ADDITIONALLY, THE PATIENT EXPERIENCED A TRANSITORY DOUBLE VISION EPISODE. THE PATIENT WAS TREATED WITH ANTICOAGULANT THERAPY. A CT SCAN PERFORMED ON (B)(6) 2021, DOCUMENTED STABILITY OF THE LESION AND THE EVENT RESOLVED WITH NO FURTHER COMPLICATIONS TO THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation; Transient Ischemic Attack

  MAUDE report 12546100 ↗
• InjuryJul 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A VENTRICULAR TACHYCARDIA (VT) ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. AFTER THE PATIENT WAS TRANSFERRED FROM THE CATH LAB, A ROUTINE TRANSTHORACIC ECHOCARDIOGRAM (TTE) REVEALED A PERICARDIAL EFFUSION HAD OCCURRED. LOCATION OF THE EFFUSION WAS NOT SPECIFIED. A DRAIN WAS PLACED ON (B)(6) 2021 AND REMOVED (B)(6) 2021 AND A CT SCAN SHOWED THE EFFUSION HAD RESOLVED. THE PATIENT IS CURRENTLY IN STABLE CONDITION. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 12187979 ↗
• DeathJun 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT EXPIRED ON (B)(6) 2021, 4 MONTHS POST PROCEDURE.

  Patient problems: Cardiac Perforation

  MAUDE report 12064354 ↗
• InjuryJun 2, 2021Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem; Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PAROXYSMAL LEFT ATRIAL FIBRILLATION ABLATION PROCEDURE, A PERFORATION OCCURRED. THE PATIENT WAS UNDER CONSCIOUS SEDATION AND HAD AN IRREGULAR BREATHING PATTERN AND A COMPLEX LEFT ATRIAL ANATOMY WITH A ROOF VEIN. THE ABLATION CATHETER SHOWED AS NOT CONNECTED ON THE GENERATOR, WHILE THERE WERE SIGNALS IN NAVX AND THE NON-ABBOTT CATHETER WAS VISIBLE IN THE CORRECT LOCATION IN NAVX. THE CONNECTION CABLE WAS EXCHANGED WHICH DID NOT RESOLVE THE ISSUE. AFTER CHANGING THE ABLATION CATHETER, THE GENERATOR SHOWED NORMAL IMPEDANCE THE ERROR MESSAGE STATING: ¿CATHETER NOT CONNECTED¿ WAS NO LONGER PRESENT. RESPIRATION REJECTION WAS USED DURING MODEL CREATION WITH A LOW VELOCITY METER SET UP. HOWEVER, THERE WAS RESPIRATION RELATED FALSE SPACE AND A LOW POINT CLOUD OF MODEL POINTS. THE MAPPING CATHETER WAS OFTEN WITH ELECTRODE 22 INSIDE THE INTRODUCER SHEATH WHICH CAUSED A RED ICON AND THE CATHETER WAS UNABLE TO COLLECT MAGNETIC POINTS. AS SOON ABLATION OF THE LEFT VEINS BEGAN, CATHETER MOVEMENT OCCURRED RELATED TO RESPIRATION. IT WAS DIFFICULT TO SEE THE CORRECT CATHETER LOCALIZATION WITHOUT USING X-RAY. AN ATTEMPT TO SWITCH OFF UPDATE RESPIRATION COMPENSATION WAS PERFORMED SEVERAL TIME

  Patient problems: Cardiac Perforation

  MAUDE report 11919261 ↗
• InjuryMay 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THREE WEEKS POST VENTRICULAR TACHYCARDIA ABLATION PROCEDURE, A PERICARDIAL EFFUSION WAS NOTED IN THE RIGHT VENTRICLE. THE PATIENT PRESENTED TO THE EMERGENCY ROOM ON (B)(6) FOLLOWING AN EPISODE OF CHEST TIGHTNESS AND DIZZINESS. A TRANSESOPHAGEAL ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION. ANOTHER ECHOCARDIOGRAM WILL BE DONE TO MONITOR THE SITUATION. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 11862016 ↗
• InjuryMar 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: (B)(4).

  Patient problems: Cardiac Perforation

  MAUDE report 11477832 ↗
• InjuryFeb 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REF: 3008452825-2021-00034. FOLLOWING THE PROCEDURE, A PERICARDIAL EFFUSION WAS DIAGNOSED VIA ECHOCARDIOGRAM THAT WAS COMPATIBLE WITH HEPARIN TREATMENT DUE TO THE ENDO-EPICARDIAL APPROACH. THE PATIENT WAS NOTED TO BE HEMODYNAMICALLY UNSTABLE AND A PIGTAIL DRAIN WAS CONDUCTED TO STABILIZE THE PATIENT. THERE WERE NO KNOWN PERFORMANCE ISSUES WITH THE DEVICES THAT CONTRIBUTED TO THE PERICARDIAL EFFUSION.

  Patient problems: Cardiac Perforation

  MAUDE report 11265760 ↗
• InjuryFeb 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REF: 3008452825-2021-00033. FOLLOWING THE PROCEDURE, A PERICARDIAL EFFUSION WAS DIAGNOSED VIA ECHOCARDIOGRAM THAT WAS COMPATIBLE WITH HEPARIN TREATMENT DUE TO THE ENDO-EPICARDIAL APPROACH. THE PATIENT WAS NOTED TO BE HEMODYNAMICALLY UNSTABLE AND A PIGTAIL DRAIN WAS CONDUCTED TO STABILIZE THE PATIENT. THERE WERE NO KNOWN PERFORMANCE ISSUES WITH THE DEVICES THAT CONTRIBUTED TO THE PERICARDIAL EFFUSION.

  Patient problems: Cardiac Perforation

  MAUDE report 11265530 ↗
• InjuryJan 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING THE VENTRICULAR TACHYCARDIA ABLATION PROCEDURE, THE PATIENT EXPERIENCE A PERICARDIAL EFFUSION. AN ECHOCARDIOGRAM EXAM AFTER THE PROCEDURE FOUND A SMALL PERICARDIAL EFFUSION AROUND THE LEFT VENTRICLE. THE PATIENT WAS ASYMPTOMATIC. A PIG TAIL DRAINAGE THAT WAS ALREADY IN SITU FROM THE ABLATION PROCEDURE WAS USED TO DRAIN THE EFFUSION. THE PATIENT WAS DISCHARGED ON (B)(6)2020 IN STABLE CONDITION.

  Patient problems: Cardiac Perforation

  MAUDE report 11226765 ↗
• InjuryDec 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING AN ENDOCARDIAL ABLATION PROCEDURE IN THE LEFT VENTRICLE, THE PATIENT EXPERIENCE AN ARRHYTHMIC STORM. TWO SHOCKS AND VENTRICULAR ANTI-TACHYCARDIA PACING WERE PERFORMED USING A DEFIBRILLATOR AND THE PATIENT WAS GIVEN ENDOVENOUS LIDOCAINE AND ENDOVENOUS CORDARONE. THE CAUSE OF THE ARRHYTHMIC STORM COULD NOT BE DETERMINED. THE PATIENT IS CURRENTLY STABLE. THERE WERE NO PERFORMANCE ISSUES WITH THE ABBOTT PRODUCT.

  Patient problems: Arrhythmia

  MAUDE report 11036467 ↗
• InjuryOct 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A VT ABLATION PROCEDURE, A COMPLETE HEART BLOCK OCCURRED. THE PATIENT ALREADY HAD A RBBB AND UNDERWENT AN ICD IMPLANT PROCEDURE. WHILE ABLATING IN THE ENDOCARDIAL SURFACE OF THE LEFT VENTRICLE, THE LEFT BUNDLE BRANCH BLOCK (LBBB) WAS OBSERVED AND WAS CONFIRMED VIA ECHOCARDIOGRAM. THE MEAN RATE OF THE DEFIBRILLATOR WAS INCREASED TO STABILIZED THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Complete Heart Block

  MAUDE report 10732973 ↗
• InjuryOct 7, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  A PSEUDOANEURYSM OCCURRED IN THE FEMORAL ARTERY DURING POST PROCEDURE. MANUAL COMPRESSION WAS APPLIED TO RESOLVE THE ISSUE.

  Patient problems: Pseudoaneurysm

  MAUDE report 10642282 ↗
• InjuryFeb 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE: 3005334138-2020-00042, 2182269-2020-00009. FOLLOWING AN ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. THE ABLATION WAS PERFORMED ON (B)(6) 2020, AND ON (B)(6) 2020 AN ECHOCARDIOGRAM CONFIRMED AN EFFUSION ON THE LEFT VENTRICLE ANTERIOR WALL. ON (B)(6) 2020, A PERICARDIOCENTESIS WAS ADMINISTERED AND ON (B)(6) 2020, THE DRAINAGE WAS REMOVED AND THE EFFUSION WAS COMPLETELY REABSORBED. THERE WERE NO PATIENT SYMPTOMS. THE PATIENT WAS DISCHARGED. IT WAS INDICATED BY THE PHYSICIAN THAT THE ABLATION ITSELF WAS THE CAUSE FOR THE EFFUSION AND NOT AN ABBOTT DEVICE. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 9667426 ↗
• InjuryOct 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE A PERICARDIAL EFFUSION AND ARTERIAL PSEUDOANEURYSM OCCURRED. DURING AN ECHOCARDIOGRAM FOLLOWING THE ABLATION, A 13 MM EFFUSION ON THE LEFT VENTRICLE LATERAL WALL AND A 3 CM ARTERIAL PSEUDOANEURYSM WERE NOTED. THE PSEUDOANEURYSM WAS SUCCESSFULLY TREATED WITH MANUAL COMPRESSION AND THE EFFUSION RESOLVED WITHOUT INTERVENTION. THE PATIENT WAS STABLE. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation; Pseudoaneurysm

  MAUDE report 9194733 ↗
• InjuryAug 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ONE DAY FOLLOWING A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE A TRANSTHORACIC ECHO REVEALED A PERICARDIAL DETACHMENT. THERE WERE NO PATIENT SYMPTOMS AND INTERVENTION WAS NOT REQUIRED. THE PATIENT WAS STABLE AND THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 8942112 ↗