FlexCath Advance™ 4FC12 (UDI 00763000418052)Recalls & reported problems

Summary

The FDA's MAUDE database contains 167 adverse event reports that list this exact device (DI 00763000418052), received between Mar 25, 2021 and Apr 6, 2026 — classified as 6 deaths, 76 injuries, 85 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (39 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 167 reports, in the reporter's own words as published by the FDA.

• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A CARDIAC ABLATION PROCEDURE, "PERICARDIAL HEMORRHAGE" OCCURRED DURING ATRIAL SEPTAL PUNCTURE. EMERGENCY PERICARDIOCENTESIS WAS PERFORMED. THE PROCEDURE WAS ABORTED. THE HOSPITALIZATION WAS EXTENDED FOR 3 DAYS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pericardial Effusion

  MAUDE report 24793010 ↗
• MalfunctionAug 22, 2025Material Twisted/Bent; Device Handling Problem; Material Twisted/Bent; Device Handling Problem

  IT WAS REPORTED THAT DURING A PULMONARY VEIN ISOLATION PROCEDURE WITH CRYO ABLATION, AFTER SUCCESSFUL COMPLETION OF THE TRANSEPTAL P UNCTURE, THE PHYSICIAN NOTED THAT THE STEERING MECHANISM OF THE FLEXCATH ADVANCE SHEATH WAS BROKEN AND THERE WAS A STEERABILITY ISSUE. THE SHEATH WAS REPLACED. THE CASE WAS SWITCHED TO AND COMPLETED WITH PULSED FIELD ABLATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22870460 ↗
• InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PULMONARY VEIN ISOLATION PROCEDURE USING THE CATHETER AFAPRO23 AFA PRO 23, THE PATIENT EXPERIENCED ST SEGMENT ELEVATION AFTER THE FIRST CRYO ABLATION IN THE LEFT INFERIOR PULMONARY VEIN. FREEZE PARAMETERS WERE NORMAL AT -63 DEGREES FOR 180 SECONDS, AND THE ONSET OF ST SEGMENT ELEVATION OCCURRED 2 MINUTES AND 45 SECONDS INTO THE FREEZE. INTERVENTIONAL CARDIOLOGY WAS CONTACTED, AND 10MG INTRAVENOUS VASODILATOR MEDICATION WAS ADMINISTERED. THE PROCEDURE WAS ABORTED UNDER GENERAL ANESTHESIA. CORONARY ANGIOGRAPHY REVEALED COMPLETED OCCLUSION OF THE RIGHT CORONARY ARTERY AND CHRONIC CORONARY ARTERY DISEASE IN THE LEFT MAIN/LEFT ANTERIOR DESCENDING ARTERIES. THE PATIENT EXHIBITED SMALL RUNS OF VENTRICULAR TACHYCARDIA AND PREMATURE VENTRICULAR CONTRACTIONS, WHICH WERE TREATED WITH 150MG OF AN ANTIARRHYTHMIC MEDICATION. AN INTERVENTIONALIST INJECTED 300MCG INTRACORONARY VASODILATOR MEDICATION INTO THE AORTIC ROOT/RIGHT CORONARY ARTERY, WHICH IMMEDIATELY RESOLVED THE ST SEGMENT ELEVATION. THE EVENT WAS DIAGNOSED AS ACUTE CORONARY SPASM. THE PATIENT WAS STABLE, TRANSFERRED TO THE INTENSIVE CARE UNIT FOR MEDICAL MANAGEMENT, AND UNDERWENT A COMPUTED TOMOGRAPHY SURG

  Patient problems: Cramp(s) /Muscle Spasm(s); Non specific EKG/ECG Changes; Tachycardia

  MAUDE report 22772134 ↗
• InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PULSED FIELD ABLATION PROCEDURE, BEFORE THE ABLATION WAS COMPLETED AND THE CARDIOVERSION WAS PERFORMED, SIGNIFICANT BLEEDING WAS OBSERVED AT THE SLIDE CONTROL ON THE LOOP CATHETER HANDLE. THE PHYSICIAN EXPRESSED CONCERN DUE TO LOSS OF AIR TIGHTNESS AT THE HANDLE AND THE LOOP CATHETER WAS REPLACED AFTER THE PATIENT'S CARDIOVERSION, AND POTENTIAL INSPECTION AND SUPERIOR CAVITY POTENTIAL ABLATION WERE PERFORMED. THE PROCEDURE WAS COMPLETED WITH CRYOABLATION. DUE TO LOSS OF AIR TIGHTNESS, THE PHYSICIAN WAS CONCERNED PATIENT MAY HAVE CAUSED AN AIR EMBOLISM. A MAGNETIC RESONANCE IMAGING (MRI) BRAIN WAS COMPLETED POST OPERATIVELY. THE PATIENT REQUIRED EXTENDED HOSPITALISATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. (B)(6) 2025 IT WAS FURTHER REPORTED THAT THE MRI SHOWED LACUNAR INFARCTION. (B)(6) 2025 IT WAS LATER REPORTED THAT THE CASE WAS COMPLETED WITH PULSED FIELD ABLATION.

  Patient problems: Air Embolism; Ischemia Stroke

  MAUDE report 22715320 ↗
• MalfunctionJul 22, 2025Material Twisted/Bent; Device Handling Problem; Material Twisted/Bent; Device Handling Problem

  IT WAS REPORTED THAT DURING A PULSE ABLATION PROCEDURE, THE SHEATH SUDDENLY COULD NOT BE BENT. REPEATED TROUBLESHOOTING WAS PERFORMED, BUT THE ISSUE COULD NOT BE RESOLVED. THE SHEATH WAS REPLACED, WHICH RESOLVED THE ISSUE. THE CASE WAS COMPLETED WITH PULSED FIELD ABLATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22567073 ↗
• MalfunctionJul 1, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, THE SHEATH TIP BECAME KINKED AND COULD NOT BE USED. THE SHEATH WAS REPLACED. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22369088 ↗
• InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, AFTER THE ATRIAL SEPTUM WAS PUNCTURED AND THE ADJUSTABLE CURVED SHEATH WAS INTRODUCED INTO THE LEFT ATRIUM, THE BALLOON CATHETER WAS ADVANCED IN PREPARATION FOR CRYOABLATION. AT THIS POINT, THE PATIENT EXPERIENCED A RAPID DROP IN BLOOD PRESSURE, WEAKENED HEART CONTRACTION, AND CONVULSIONS. DS IMAGING WAS USED AND IDENTIFIED PERICARDIAL TAMPONADE. RESUSCITATION EFFORTS INITIATED, AND PERICARDIOCENTESIS WAS PERFORMED, WITH MORE THAN 100 ML DRAINED. THE PATIENT REQUIRED MORE THAN 2 HOURS OF RESUSCITATION AND WAS SUBSEQUENTLY STABILIZED AND TRANSFERRED TO THE INTENSIVE CARE UNIT FOR MONITORING AND TREATMENT.  THE PROCEDURE WAS ABORTED, AND NO ABLATION WAS PERFORMED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 22139635 ↗
• InjuryJun 3, 2025Compatibility Problem; Adverse Event Without Identified Device or Use Problem; Compatibility Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE SURGEON PERFORMED AN ATRIAL SEPTAL PUNCTURE. SINCE THE OUTER SHEATH DIAMETER OF THE ADJUSTABLE CURVED CATHETER SHEATH WAS 15F, IT WAS DIFFICULT TO DELIVER AFTER ENTERING INTO THE FEMORAL VEIN. THE SURGEON DECIDED TO USE A BLADE TO DILATE THE SKIN OF THE PATIENT'S FEMORAL VEIN. DUE TO THE PATIENT'S ANATOMY, THE BLADE SCRATCHED THE FEMORAL ARTERY, CAUSING THE PATIENT TO BLEED CONTINUOUSLY. AT THIS TIME, CORRESPONDING RESCUE MEASURES WERE TAKEN AND THE PATIENT WAS OBSERVED FOR TWO HOURS. THE PATIENT WAS OUT OF DANGER AND TRANSFERRED TO THE WARD FOR CONTINUOUS OBSERVATION. THE CASE WAS ABORTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22132736 ↗
• InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A CRYO ABLATION PROCEDURE, POST-PROCEDURE THE PATIENT EXPERIENCED SEVERAL ADVERSE EVENTS. POST PROCEDURE THE PATIENT EXHIBITED INFLAMMATION DUE TO PERICARDITIS. THE PATIENT LATER PRESENTED TO THE EMERGENCY DEPARTMENT (ED) WITH TACHYCARDIA ARRIVING WITH A HEART RATE IN THE 140S. THE PATIENT WAS MILDLY HYPOTENSIVE. THE PATIENT WAS PLACED ON A SALINE BOLUS AND A CALCIUM BLOCKER MEDICATION WAS ADMINISTERED. THE PATIENT WAS ELECTRICALLY CARDIOVERTED TO NORMAL SINUS RHYTHM AND DISCHARGED FROM THE ED. TWO DAYS LATER THE PATIENT RETURNED TO THE ED WITH IRREGULAR HEARTBEAT IN THE 130S AND 140S. THE PATIENT AS EXAMINED AND IT WAS OBSERVED THAT THE PATIENT HAD A DISTINCTLY REGULAR RHYTHM WITH RAPID HEARTBEAT. AN ELECTROCARDIOGRAM (EKG) TEST CONFIRMED ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. PRIOR TO ADMINISTRATION OF A CALCIUM BLOCKER, THE PATIENT RETURNED TO NORMAL SINUS RHYTHM AND WAS DISCHARGED HOME. THREE DAYS LATER THE PATIENT RETURNED TO THE ED WITH PALPITATIONS AND SHORTNESS OF BREATH. A BETA BLOCKER WAS ADMINISTERED TO THE PATIENT WITHOUT RESOLUTION FOR THE ATRIAL FIBRILLATION. ANTIARRHYTHMIC MEDICATION WAS ADMINISTERED TO THE PATIENT. THE PATIEN

  Patient problems: Arrhythmia; Atrial Fibrillation; Dyspnea; Low Blood Pressure/ Hypotension

  MAUDE report 21773670 ↗
• InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE INVOLVING BOTH CRYOABLATION AND RADIOFREQUENCY, THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION (VF) ARREST. INITIALLY, THE PULMONARY VEINS WERE ABLATED USING CRYOABLATION. IT WAS NOTED THE PATIENT'S OXYGEN SATURATIONS HAD DROPPED DURING THE LAST FREEZE. THE PATIENT THEN HAD RADIOFREQUENCY WITH ANOTHER MANUFACTURER'S CATHETER TO ABLATE THE POSTERIOR WALL. PATIENT THEN EXPERIENCED AN EXTREMELY LOW RHYTHM WHICH PROGRESSED TO VENTRICULAR FIBRILLATION. RESUSCITATION MEASURES, WHICH INCLUDED CARDIOPULMONARY RESUSCITATION (CPR) AND EXTERNAL SHOCKS WERE CARRIED OUT. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT. IT WAS FURTHER NOTED PATIENT HAD SUSTAINED FRACTURED RIBS, POSSIBLY RELATED TO THE CHEST COMPRESSIONS. THE PROCEDURE WAS COMPLETED USING BOTH CRYO AND RADIOFREQUENCY WITH ANOTHER MANUFACTURER'S CATHETER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bone Fracture(s); Bradycardia; Low Oxygen Saturation; Ventricular Fibrillation

  MAUDE report 21692112 ↗
• InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS LATER REPORTED THAT THE CASE WAS COMPLETED WITH CRYO.

  Patient problems: Chest Pain; Dyspnea; Pericarditis

  MAUDE report 21409934 ↗
• InjuryDec 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE PATIENT EXPERIENCED HYPOTENSION PRIOR TO THE INSERTION OF THE SHEATH. THE PATIENT DEVELOPED A PERICARDIAL EFFUSION AND CARDIAC TAMPONADE. BASELINE IMAGING WAS OBTAINED TO ASSESS FOR PERICARDIAL EFFUSION PRIOR TO THE PROCEDURE. A PERICARDIOCENTESIS WAS PERFORMED TO ADDRESS THE EFFUSION AND TAMPONADE, WHICH RESULTED IN SYMPTOM RESOLUTION PRIOR TO LEAVING THE LAB. THE CASE WAS ULTIMATELY ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 20891842 ↗
• InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE INSERTION OF A CRYOBALLOON INTO THE LEFT ATRIUM, A THROMBUS WAS OBSERVED ON THE SHEATH AT THE RIGHT ATRIAL SEPTUM AFTER TRANSSEPTAL CROSSING. THE CASE WAS ABORTED BEFORE ANY CRYOTHERAPY DELIVERY. DESPITE ASPIRATION ATTEMPTS, THE THROMBUS REMAINED VISIBLE ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE). A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED, AND THE PATIENT WAS TREATED WITH ANTICOAGULANT MEDICATION. THE PATIENT'S HOSPITALIZATION WAS EXTENDED FOR MONITORING. THE PROCEDURE WAS ABORTED, AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20869781 ↗
• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Device Handling Problem; Adverse Event Without Identified Device or Use Problem; Device Handling Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION. IT WAS FURTHER REPORTED THAT THE ACCESS TO THE LEFT ATRIUM WAS LOST AND WHEN THE PHYSICIAN ATTEMPTED TO REGAIN ACCESS, THE PATIENT EXPERIENCED A DROP IN BLOOD PRESSURE. A PERICARDIAL EFFUSION WAS FOUND ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE). A PERICARDIOCENTESIS WAS PERFORMED AND A DRAIN WAS LEFT IN THE PATIENT. THE PATIENT WAS TRANSFERRED TO THE HOSPITAL FLOOR AND HOSPITALIZATION WAS EXTENDED. IT WAS NOTED THAT NEITHER A DILATOR, NEEDLE, NOR A GUIDEWIRE WERE USED IN THE ATTEMPT TO REGAIN TRANSSEPTAL ACCESS. ADDITIONALLY, THE PHYSICIAN ALLEGED THAT A TAMPONADE CONTRIBUTED TO THE PERICARDIAL EFFUSION. THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE PATIENT HAS BEEN DISCHARGED TO HOME. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 20566069 ↗
• DeathOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE PATIENT HAD HYPOTENSION, PERICARDIAL EFFUSION, AND CARDIAC TAMPONADE. THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. A PERICARDIOCENTESIS WAS PERFORMED AND THEN THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS SURMISED TO BE PERICARDIAL EFFUSION AND CARDIAC TAMPONADE.

  Patient problems: Bradycardia; Cardiac Tamponade; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 20515164 ↗
• MalfunctionSep 9, 2024Compatibility Problem; Material Twisted/Bent; Compatibility Problem; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE DILATOR COULD NOT BE INSERTED INTO THE SHEATH. THE SHEATH WAS REPLACED WHICH RESOLVED THE ISSUE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20168837 ↗
• InjuryAug 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE DAY POST-OPERATIVELY TO A CRYO ABLATION PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH SHARP SUBSTERNAL CHEST PAIN. INITIAL CARDIAC MARKERS AND ELECTROCARDIOGRAM (ECG) INDICATED LOW SUSPICION FOR AN ACUTE CORONARY SYNDROME. AN ELEVATED TROPONIN LEVEL WAS NOTED DUE TO RECENT ABLATION AND AN ADDITIONAL ECG WAS PERFORMED. NO ARRHYTHMIAS WERE OBSERVED. AN ECHOCARDIOGRAM WAS ALSO PERFORMED AND SHOWED NO PERICARDIAL EFFUSION. THE PATIENT WAS HOSPITALIZED. TWO DAYS LATER, THE PATIENT RECOVERED AND WAS DISCHARGED. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Enzyme Elevation; Chest Pain

  MAUDE report 19986275 ↗
• MalfunctionJul 23, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, AIR BUBBLES WERE OBSERVED UPON ADVANCEMENT OF THE BALLOON CATHETER INTO THE SHEATH SIDEPORT. THE BALLOON CATHETER WAS REMOVED AND RE-PREPPED, AND THE SHEATH WAS ASPIRATED AND FLUSHED WITHOUT RESOLUTION. THE ENTIRE SYSTEM WAS RE-PREPPED AGAIN WHICH RESOLVED THE ISSUE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19809844 ↗
• MalfunctionJun 11, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, AFTER INSERTING THE BALLOON CATHETER INTO THE SHEATH AND ASPIRATING, AIR WAS PULLED THROUGH THE SIDE PORT. IT WAS REPORTED THAT AIR WAS BEING PULLED THROUGH THE HEMOSTATIC VALVE. THE BALLOON CATHETER AND SHEATH WERE REPLACED, BUT THE SAME ISSUES OCCURRED. THEY WERE REPLACED AGAIN WHICH RESOLVED THE ISSUE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19509214 ↗
• MalfunctionJun 11, 2024Fluid/Blood Leak; Compatibility Problem; Fluid/Blood Leak; Compatibility Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, AFTER INSERTING THE BALLOON CATHETER INTO THE SHEATH AND ASPIRATING, AIR WAS PULLED THROUGH THE SIDE PORT. IT WAS REPORTED THAT AIR WAS BEING PULLED THROUGH THE HEMOSTATIC VALVE. THE BALLOON CATHETER AND SHEATH WERE REPLACED, BUT THE SAME ISSUES OCCURRED. THEY WERE REPLACED AGAIN WHICH RESOLVED THE ISSUE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19509207 ↗
• MalfunctionMay 21, 2024Gas/Air Leak; Compatibility Problem; Gas/Air Leak; Compatibility Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, IT WAS MORE DIFFICULT THAN USUAL TO INSERT THE BALLOON CATHETER INTO THE SHEATH. IT WAS ALSO REPORTED THAT WHEN ASPIRATING, AIR INGRESS WAS OBSERVED. ADDITIONAL ASPIRATION MANEUVERS WERE PERFORMED; HOWEVER, MULTIPLE AIR BUBBLES WERE STILL PRESENT. THE BALLOON CATHETER AND SHEATH WERE REPLACED WHICH RESOLVED THE ISSUES. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19360930 ↗
• MalfunctionMay 13, 2024Mechanical Problem; Material Twisted/Bent; Device Handling Problem; Mechanical Problem; Material Twisted/Bent; Device Handling Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THERE WAS TIP DAMAGE TO THE SHEATH. IT WAS ALSO REPORTED THAT THE SHEATH AND THE BALLOON CATHETER LOST RESPONSIVENESS AND MANEUVERABILITY WHILE POSITIONED AT THE LAST PULMONARY VEIN. DESPITE THE ISSUES, THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19305822 ↗
• MalfunctionMay 13, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THERE WAS AIR INGRESS. THE BALLOON CATHETER AND SHEATH WERE REPLACED WITHOUT RESOLUTION. THE BALLOON CATHETER AND SHEATH WERE REPLACED AGAIN WHICH RESOLVED THE ISSUE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19300217 ↗
• MalfunctionMay 13, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THERE WAS AIR INGRESS. THE BALLOON CATHETER AND SHEATH WERE REPLACED WITHOUT RESOLUTION. THE BALLOON CATHETER AND SHEATH WERE REPLACED AGAIN WHICH RESOLVED THE ISSUE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19300025 ↗
• DeathMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING THE COMPLETED PORTION OF THE CRYO ABLATION PROCEDURE, ALL SHEATHS AND CATHETERS WERE REMOVED FROM THE PATIENT. PROTAMINE WAS GIVEN TO THE PATIENT AND THE PATIENT HAD AN ONSET OF HYPOTENSION. THE PATIENT WAS REINTUBATED AND BLOOD WAS SUBSEQUENTLY OBSERVED TO BE POOLING THROUGH THE INTUBATION TUBE. ADDITIONALLY, THE PATIENT BECAME HYPOXIC. RESUSCITATION WAS ATTEMPTED BUT THE ATTEMPTS WERE UNSUCCESSFUL. THE PATIENT DIED. IT WAS NOTED THAT DURING THE CASE, THE ESOPHAGEAL TEMPERATURES WERE RECORDED, THE PHRENIC NERVE WAS PACED AND REMAINED NORMAL THROUGHOUT THE PROCEDURE, AND INTRACARDIAC ECHOCARDIOGRAPHY (ICE) SHOWED NO PERICARDIAL EFFUSION. IT WAS SUSPECTED THAT THE PATIENT MAY HAVE HAD AN ANAPHYLACTIC REACTION.

  Patient problems: Anaphylactoid / Anaphylaxis; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hypoxia; Low Blood Pressure/ Hypotension

  MAUDE report 19274671 ↗