FlexAbility™ A-FASE-FJRecalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 05415067020086), received between Oct 23, 2018 and Jan 9, 2026 — classified as 1 death, 27 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  DURING AN AVNRT PROCEDURE, THE PATIENT EXPERIENCED AV BLOCK WHILE TARGETING THE SLOW PATHWAY. NO INTERVENTION WAS PERFORMED TO TREAT THE ARRHYTHMIA. THE AV BLOCK APPEARED 15MM FROM THE BUNDLE OF HIS IN A ZONE WITH ALMOST NO A SIGNAL. AT THE END OF THE PROCEDURE, THE ARRHYTHMIA WAS STILL PRESENT. THERE WERE NO PERFORMANCE ISSUES WITH THE FLEXABILITY CATHETER.

  Patient problems: Arrhythmia

  MAUDE report 24026446 ↗
• InjuryJun 18, 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. ABLATION WAS COMPLETED ON THE LEFT PULMONARY VEINS WITHOUT ANY ISSUES AND A FEW ABLATIONS WERE PERFORMED AT THE BASE OF THE APPENDAGE. AN IMPEDANCE SHIFT WAS NOTED DURING ABLATION OF THE RIGHT PULMONARY VEINS AND PATIENT BECAME HYPOTENSIVE AND TACHYCARDIC. AN ULTRASOUND WAS PERFORMED CONFIRMING THE PERICARDIAL EFFUSION. A IT IS UNKNOWN WHEN, WHERE, AND WHAT CAUSED THE PERICARDIAL EFFUSION. THE PATIENT IS STABLE. THERE ARE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 22286403 ↗
• InjuryFeb 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A STEAM POP OCCURRED RESULTING IN A HEMOPERICARDIUM REQUIRING SURGICAL REPAIR. DURING ABLATION ON THE CTI A STEAM POP OCCURRED, AND THE PATIENT BECAME HYPOTENSIVE. THE PATIENT WAS THEN CARDIOVERTED BACK TO SINUS RHYTHM. A TRANSESOPHAGEAL ULTRASOUND SHOWED A HEMOPERICARDIUM AND A PERICARDIOCENTESIS WAS PERFORMED. AUTO PERFUSION WAS STARTED AFTER 1 LITER WAS DRAINED. AN HOUR LATER, THE HEMOPERICARDIUM WAS STILL VISIBLE SO THE PATIENT WAS TRANSFERRED TO CARDIAC SURGERY WHERE THE PATIENT BENEFITED FROM TWO HEMOSTASIS POINTS ON THE RIGHT VENTRICLE NEAR TO THE VALVE AND IS NOW STABLE.

  Patient problems: Cardiac Perforation

  MAUDE report 21323320 ↗
• InjuryNov 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT EXPERIENCED WEAKNESS AND LOW BLOOD PRESSURE AND WAS ADMITTED TO THE HOSPITAL. A PERICARDIAL EFFUSION WAS NOTED ON TTE WHICH REQUIRED A PERICARDIOCENTESIS TO STABILIZE THE PATIENT. PATIENT WAS STILL IN THE HOSPITAL AS OF (B)(6) 2024

  Patient problems: Cardiac Perforation

  MAUDE report 20663257 ↗
• InjuryAug 15, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING A TYPICAL ATRIAL FLUTTER ABLATION, ST ELEVATION WAS NOTED AND A STENT WAS PLACED. WHILE COMPLETING A CTI LINE, A STEAM POP OCCURRED DURING ABLATION AND THE PATIENT WENT INTO A JUNCTIONAL RHYTHM WITH ST ELEVATION. AN EMERGENT CORONARY CATHETERIZATION WAS PERFORMED SHOWING TOTAL OCCLUSION OF THE DISTAL RIGHT CORONARY ARTERY (RCA). ONE STENT WAS PLACED IN THE DISTAL RCA, OPENING THE VESSEL AND RESOLUTION OF THE ST ELEVATION.

  Patient problems: Arrhythmia

  MAUDE report 17550845 ↗
• InjuryNov 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A TYPICAL FLUTTER ABLATION, AN EFFUSION OCCURRED AND A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. IT WAS NOTICED THAT THE HEART SILHOUETTE WASN¿T BEATING AS MUCH AS IT WAS AT THE START ON FLUOROSCOPY. AN ECHOCARDIOGRAM REVEALED AN EFFUSION, AND A PERICARDIOCENTESIS WAS DONE TO STABILIZE THE PATIENT. IT IS UNKNOWN THE CAUSE OF THE PERFORATION OR WHERE IT OCCURRED, ALTHOUGH IT WAS LIKELY IN THE RIGHT ATRIUM.

  Patient problems: Cardiac Perforation

  MAUDE report 15798915 ↗
• InjuryDec 8, 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. AT A CONTROLLED ECHOCARDIOLOGY POST ABLATION, A MILD PERICARDIAL EFFUSION WAS NOTED WITH NO PATIENT SYMPTOMS. A DRAIN WAS PLACED AND THE EFFUSION WAS RESOLVED. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES. FOLLOWING THE ABLATION PROCEDURE, THE PATIENT WAS IN STABLE CONDITION. IT WAS NOTED THAT THE AVERAGE BURN TIME WAS 15-20 SECONDS. THE ACT DURING PROCEDURE WAS MINIMUM 321 SECONDS AND MAXIMUM 389 SECONDS.

  Patient problems: Cardiac Perforation

  MAUDE report 12963096 ↗
• InjuryOct 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING THE PROCEDURE, AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION HAD OCCURRED IN THE RIGHT ATRIUM. A STERNOTOMY WAS PERFORMED AND A PERFORATION HAD OCCURRED IN THE CORONARY SINUS. THERE WERE NO PERFORMANCE ISSUED WITH ANY ABBOTT DEVICES. THE ONLY CATHETER IN THE CORONARY SINUS WAS THE INQUIRY CATHETER. PER THE PHYSICIAN, THE STEAM POP WAS NOT RELATED TO THE PERFORATION.

  Patient problems: Cardiac Perforation

  MAUDE report 12578424 ↗
• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A VENTRICULAR TACHYCARDIA (VT) PROCEDURE, A TRANSTHORACIC ECHOCARDIOGRAM (TTE) REVEALED A LV THROMBUS. NEUROLOGICAL FUNCTION WAS NORMAL AND THERE WERE NO SIGNS OF PULMONARY EMBOLISM. THE PATIENT WAS STARTED ON LOVENOX FOR TREATMENT OF THE LV THROMBUS. FURTHER INFORMATION REGARDING THIS EVENT IS NOT AVAILABLE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12370727 ↗
• InjuryJun 24, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING A TYPICAL CAVO-TRICUSPID ISTHMUS (CTI) ATRIAL FLUTTER ABLATION PROCEDURE, A STEAM POP AND PERICARDIAL EFFUSION OCCURRED. WHILE ABLATING A LINE FROM THE TRICUSPID VALVE TOWARDS THE INFERIOR VENA CAVA NO IMPEDANCE RISE WAS NOTED, BUT A THERE WAS A FAINT AUDIBLE STEAM POP. THE LESION WAS COMPLETED SUCCESSFULLY BUT A FEW MINUTES LATER THE PATIENT BECAME HYPOTENSIVE. AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT.

  Patient problems: Cardiac Perforation

  MAUDE report 12056873 ↗
• InjuryApr 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A LEFT VENTRICULAR TACHYCARDIA ABLATION PROCEDURE, A PERICARDIAL EFFUSION WAS DISCOVERED USING TRANSTHORACIC ECHOGRAPHY AT THE END OF THE PROCEDURE. THE PATIENT WAS NOTED TO BE HYPOTENSIVE AND A PERCUTANEOUS DRAIN WAS PLACED. AFTER THIRTY MINUTES, THE PATIENT WAS STILL HYPOTENSIVE AND NO IMPROVEMENT WAS NOTED, SO THE PATIENT WAS TAKEN INTO SURGERY WITH EXTRA CORPORAL CIRCULATION AND A SPONGE PATCH WAS PLACED. NO PERFORATION WAS NOTED, BUT PATCHY BLEEDING WAS NOTED ON THE LEFT VENTRICULAR LATERAL WALL AT THE ABLATION SITE, WHICH WAS NOTED TO BE VERY THIN AND ISCHEMIC. THE PATIENT WAS NOTED TO EVENTUALLY STABILIZE. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 11659891 ↗
• InjuryMar 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER PROCEDURE NOTE AND FOLLOW UP ECHO ON (B)(6) 2019, THERE WAS NO PERICARDITIS OR PERICARDIAL EFFUSION. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation; Insufficient Information

  MAUDE report 11542696 ↗
• InjuryJan 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE PERSISTENT ATRIAL FIBRILLATION ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. THE PATIENT EXPERIENCED HYPOTENSION AND HYPOCAPNIA, AND THE ATRIAL FIBRILLATION ORGANIZED INTO ATRIAL TACHYCARDIA. THE ECHOCARDIOGRAM WAS CHECKED, AND PERICARDIAL EFFUSION WAS VISIBLE ALL AROUND THE HEART ON BOTH THE LEFT AND RIGHT SIDES. A PERICARDIOCENTESIS WAS PERFORMED AND THE PROCEDURE WAS ABANDONED. FOLLOWING DRAINAGE OF THE EFFUSION, THE PATIENT WAS CARDIOVERTED TO RETURN TO SINUS RHYTHM. THE PATIENT WAS STABLE AT THE END OF THE PROCEDURE AND WAS TRANSFERRED TO THE INTENSIVE CARDIOLOGY UNIT WITH A DRAIN. THE FOLLOWING MORNING, THE PATIENT WAS COMPLETELY STABLE. IT WAS NOT KNOWN WHEN THE EFFUSION OCCURRED. PRIOR TO THE EFFUSION, IMPEDANCE ROSE TO OVER 150 OHMS WHILE ABLATING SEVERAL SHORT LESIONS IN THE CORONARY SINUS; THERE WAS A STEAM POP WHILE ABLATING ON THE ANTERIOR WALL; AND THERE WAS ABLATION WITH NO ISSUES AT THE CAVOTRICUSPID ISTHMUS. THE PHYSICIAN BELIEVED THE CAUSE OF THE PERICARDIAL EFFUSION WAS LIKELY THE ABLATION CATHETER. THERE WAS NO ALLEGATION OF PERFORMANCE ISSUES WITH ANY ABBOTT PRODUCT.

  Patient problems: Cardiac Perforation

  MAUDE report 11186168 ↗
• InjuryDec 29, 2020Signal Artifact/Noise; Signal Artifact/Noise

  RELATED MANUFACTURER REPORT NUMBER: 3005334138-2020-00654. DURING A VT ABLATION PROCEDURE, NOISE WAS NOTED ON THE CATHETER. A SECOND DEVICE WAS ATTEMPTED, BUT THE SAME ISSUE OCCURRED. A THIRD DEVICE WAS ATTEMPTED, AND THE NOISE WAS STILL PRESENT. HOWEVER, THE PROCEDURE WAS CONTINUED WITH THE THIRD CATHETER WITH THE NOISE PRESENT AND NO ADVERSE CONSEQUENCES TO THE PATIENT. A CLINICALLY SIGNIFICANT DELAY OCCURRED AND THE PATIENT WAS GIVEN ADDITIONAL ANESTHESIA DURING THE PROCEDURE DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11089721 ↗
• InjuryNov 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MFR NO. 2182269-2020-00094; 2182269-2020-00093. DURING A RIGHT VENTRICULAR OUTFLOW TRACT PREMATURE VENTRICULAR CONTRACTION ABLATION, A PERICARDIAL EFFUSION WAS OBSERVED AND THE PROCEDURE WAS CANCELLED. WHILE ABLATING THE ANTERIOR ASPECT, HYPOTENSION WAS NOTED, AND A PERICARDIAL EFFUSION WAS FOUND VIA ULTRASOUND. THE CASE WAS ABANDONED, AND A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT.

  Patient problems: Cardiac Perforation

  MAUDE report 10800515 ↗
• InjuryJul 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED A POTENTIAL CEREBROVASCULAR INJURY, RESPIRATORY FAILURE, AND ELEVATED WHITE BLOOD CELL COUNT. POST ABLATION, THE PATIENT HAD RESPIRATORY SECRETIONS AND BLOCKAGES OF FOUR LOBES IN THE LUNGS. THE SECRETIONS WERE REMOVED AND DIURESIS WAS PERFORMED AND THE PATIENT WAS SUCCESSFULLY EXTUBATED. THE RESPIRATORY COMPROMISE WAS ATTRIBUTED TO VOLUME OVERLOAD DURING THE PROCEDURE AND GENERAL ANESTHESIA. ADDITIONALLY, THE PATIENT'S WHITE BLOOD CELL COUNT (WBC) WAS ELEVATED, HOWEVER THIS OCCURRED DUE TO INTRA-AORTIC BALLOON PUMP INSERTION. ANTIBIOTICS WERE ADMINISTERED AND THE WBC COUNT DECREASED. THE PATIENT ALSO COMPLAINED OF DIPLOPIA POST PROCEDURE AND A CT WAS PERFORMED WHICH REVEALED NO EVIDENCE OF ACUTE INFARCT OR INTRACRANIAL HEMORRHAGE BUT A SMALL CHRONIC LEFT CEREBELLAR INFARCT WAS PRESENT. THE PATIENT'S ACT WAS BETWEEN 268 AND 334 THROUGHOUT THE PROCEDURE. THE PATIENT WAS ADMINISTERED HEPARIN AND STATIN AND THE SYMPTOMS RESOLVED AFTER THE PATIENT WAS DISCHARGED. THE PATIENT HAD A HISTORY OF TRANSIENT ISCHEMIC ATTACKS WITH NO RESIDUAL DEFICITS. ECHO WAS PERFORMED A WEEK BEFORE THE PROCEDURE TO RULE OUT THROMBUS AND ICE WAS PERFORMED PRIOR

  Patient problems: Stroke/CVA

  MAUDE report 10285808 ↗
• InjuryJun 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 3005334138-2020-00258, 3005334138-2020-00260. FOLLOWING A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE THE PATIENT DEVELOPED SEVERE MITRAL INSUFFICIENCY. ABLATION PROCEDURES WERE PERFORMED ON (B)(6) 2019 AND (B)(6) 2019 AND NO PERFORMANCE ISSUES WERE NOTED WITH ANY ABBOTT DEVICE DURING EITHER PROCEDURE. IN (B)(6) 2020 THE PATIENT WAS DIAGNOSED WITH SEVERE MITRAL INSUFFICIENCY DUE TO A RUPTURED CHORDA THAT MAY HAVE BEEN A RESULT OF THE ABLATION PROCEDURES. THE PATIENT UNDERWENT A MITRAL CLIP PROCEDURE AND WAS DISCHARGED HOME ON (B)(6) 2020 IN STABLE CONDITION.

  Patient problems: Mitral Insufficiency; Tissue Damage

  MAUDE report 10206508 ↗
• InjuryJun 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 3005334138-2020-00258, 3005334138-2020-00259. FOLLOWING A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE THE PATIENT DEVELOPED SEVERE MITRAL INSUFFICIENCY. ABLATION PROCEDURES WERE PERFORMED ON (B)(6) 2019 AND (B)(6) 2019 AND NO PERFORMANCE ISSUES WERE NOTED WITH ANY ABBOTT DEVICE DURING EITHER PROCEDURE. IN (B)(6) 2020 THE PATIENT WAS DIAGNOSED WITH SEVERE MITRAL INSUFFICIENCY DUE TO A RUPTURED CHORDA THAT MAY HAVE BEEN A RESULT OF THE ABLATION PROCEDURES. THE PATIENT UNDERWENT A MITRAL CLIP PROCEDURE AND WAS DISCHARGED HOME ON (B)(6) 2020 IN STABLE CONDITION.

  Patient problems: Mitral Insufficiency; Tissue Damage

  MAUDE report 10206504 ↗
• InjurySep 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED ON 1/28/2020 INDICATED THE PATIENT HAD AN AORTIC VALVE REPLACEMENT AND TRICUSPID VALVE REPAIR.

  Patient problems: Pericardial Effusion; Valvular Insufficiency/ Regurgitation

  MAUDE report 9097744 ↗
• InjurySep 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EFFUSIONS WERE RESOLVED AND THE PATIENT WAS DISCHARGED. DURING A 30 DAY FOLLOW UP, THE PATIENT WAS NOTED TO BE IN ATRIAL FIBRILLATION AND CARDIOVERSION WOULD BE SCHEDULED.

  Patient problems: Cardiac Perforation; Pleural Effusion

  MAUDE report 9005920 ↗
• InjuryJul 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. RADIOFREQUENCY (RF) ABLATION WAS BEING PERFORMED AROUND THE LEFT SUPERIOR PULMONARY VEIN WHEN THE PATIENT BECAME HYPOTENSIVE. AN INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER REVEALED A PERICARDIAL EFFUSION, FOR WHICH A STERNOTOMY WITH SURGICAL REPAIR WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 8827301 ↗
• InjuryJul 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, AN EFFUSION OCCURRED. WHILE ABLATING WITH THE FLEXABILITYSE ALONG THE SUPERIOR RIDGE BETWEEN THE LEFT ATRIAL APPENDAGE AND THE LEFT SUPERIOR PULMONARY VEIN, THE PATIENT BECAME HYPOTENSIVE. ICE IMAGES CONFIRMED A PERICARDIAL EFFUSION. IT WAS NOTED BY THE PHYSICIAN, A STEAM POP WAS HEARD WHILE ABLATING IN THAT AREA. ALL CATHETERS WERE THEN REMOVED FROM THE LEFT ATRIUM AND A PERICARDIOCENTESIS WAS PERFORMED AND PROTAMINE WAS ALSO ADMINISTERED. THE ICE VISUAL ALSO SHOWED A VISUAL OF A PRE EXISTING EFFUSION OF APPROXIMATELY 1CM PRIOR TO THE START OF ABLATION. AFTER THE PHYSICIAN DEEMED THAT THE PATIENT WAS STABLE ENOUGH TO CONTINUE ABLATION. DURING THE CTI ABLATION, ICE IMAGES SHOWED THE PERICARDIAL EFFUSION WOULD SLOWLY AND STEADILY RE-ACCUMULATE. APPROXIMATELY ANOTHER LITER AND A HALF WAS EXTRACTED THROUGHOUT AND POST CTI ABLATION. THE PATIENT LEFT THE LAB IN STABLE CONDITION TO THE OPERATING ROOM FOR A SURGICAL EXPLORATORY PROCEDURE DUE TO THE EFFUSION NOT RESOLVING. THE SURGERY CONFIRMED A PERFORATION HOLE THAT WAS REPAIRED, HOWEVER THERE WAS NO SPECIFIC LOCATION. THE PHYSICIAN ALLEGED THE FLEXABILITY CAUSED THE EFFUSION. THERE WERE

  Patient problems: Cardiac Perforation

  MAUDE report 8752521 ↗
• InjuryJun 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: 3008452825-2019-00272, 3005334138-2019-00303. DURING A PREMATURE VENTRICULAR CONTRACTION PROCEDURE, A CARDIAC TAMPONADE OCCURRED. WHILE ABLATING ALONG THE RIGHT VENTRICULAR OUTFLOW TRACT AT 40 WATTS IN TEMPERATURE CONTROL MODE, A STEAM POP OCCURRED. ABLATION WAS STOPPED AND THE PATIENT WAS MONITORED. THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY. THE PATIENT WAS TRANSFERRED IN STABLE CONDITION FOR MONITORING AND BECAME HYPOTENSIVE. AN ECHOCARDIOGRAM WAS PERFORMED AND REVEALED A CARDIAC TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 8686957 ↗
• MalfunctionApr 18, 2019Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  AT THE BEGINNING OF AN ATRIAL FIBRILLATION PROCEDURE, THE NON-ABBOTT INTRODUCER WAS INADVERTENTLY INSERTED INTO THE ARTERY INSTEAD OF THE VEIN. THE ABLATION CATHETER WAS INSERTED THROUGH THE INTRODUCER BUT WHEN THE INTRODUCER LOCATION WAS DISCOVERED, THE ABLATION CATHETER WAS ATTEMPTED TO BE REMOVED. THE INTRODUCER HAD BECAME FOLDED AND DIFFICULTY WAS NOTED REMOVING THE CATHETER. WHEN THE CATHETER WAS REMOVED, THE DISTAL PORTION OF THE DEVICE DETACHED INTO THE SHEATH. THE DETACHED PORTION OF THE CATHETER AND THE INTRODUCER WERE SUCCESSFULLY REMOVED. THE DEVICES WERE REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8529550 ↗
• InjuryApr 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: 2182269-2019-00038, 005334138-2019-00195. DURING A REDO PULMONARY VEIN ISOLATION PROCEDURE, THE LEFT ATRIUM WAS SUCCESSFULLY ABLATED NEAR THE PULMONARY VEINS AND THE CATHETERS WERE WITHDRAWN TOWARD THE RIGHT ATRIUM. AFTER WITHDRAWING THE CATHETERS TO THE RIGHT ATRIUM, THE PATIENT BECAME HYPOTENSIVE. AN INTRACARDIAC ECHOGRAM REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED AND A DRAIN WAS INSERTED UNTIL THE PATIENT STABILIZED. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 8499211 ↗