ACHIEVE ADVANCE™ 2ACH20Recalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 00643169590984), received between May 24, 2017 and Dec 30, 2024 — classified as 3 deaths, 25 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (27 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 69 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, A CIRCULAR MAPPING LEAD WAS FOUND TO BE KINKED DURING PLACEMENT. THE SURGEON REQUESTED THE REPLACEMENT OF THE KINKED CIRCULAR MAPPING LEAD. THE PROCEDURE 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 21045182 ↗
• MalfunctionDec 2, 2024Compatibility Problem; Material Twisted/Bent; Compatibility Problem; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING A MAPPING CATHETER, THERE WAS DIFFICULTY INSERTING THE MAPPING CATHETER INTO THE BALLOON. UPON SUCCESSFUL INSERTION, A DEFORMED LOOP AND PHYSICAL DAMAGE, SPECIFICALLY A TIP/LOOP KINK, WERE OBSERVED ON THE MAPPING CATHETER. THE MAPPING CATHETER WAS REPLACED TO RESOLVE THE ISSUE. THE PROCEDURE 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 20819569 ↗
• MalfunctionAug 27, 2024Signal Artifact/Noise; Material Twisted/Bent; Signal Artifact/Noise; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE PROXIMAL END OF THE MAPPING CATHETER WAS BENT AND BROKEN, LEADING TO SIGNAL ISSUES. MULTIPLE ATTEMPTS WERE MADE TO RESTORE THE DEVICE WITH NO RESOLUTION. THE MAPPING CATHETER WAS 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 20075457 ↗
• MalfunctionAug 12, 2024Signal Artifact/Noise; Compatibility Problem; Material Twisted/Bent; Signal Artifact/Noise; Compatibility Problem; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THERE WAS NOISE ON ELECTRODES ONE, TWO, AND THREE. IT WAS THEN REPORTED THAT WHEN RETRACTING THE MAPPING CATHETER INTO THE BALLOON CATHETER, THERE WAS RESISTANCE. ADDITIONALLY, AFTER THE MAPPING CATHETER WAS REMOVED FROM THE PATIENT, IT WAS OBSERVED THAT THE LOOP WAS KINKED. THE MAPPING CATHETER WAS 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 19962530 ↗
• InjuryJun 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS LATER REPORTED THAT THE PATIENT WAS RUSHED TO THE SURGICAL DEPARTMENT FOR EMERGENCY TREATMENT BUT THE SPECIFIC INTERVENTION IS UNKNOWN. THE PATIENT'S HOSPITALIZATION WAS EXTENDED AND IS STILL CURRENTLY HOSPITALIZED.

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension

  MAUDE report 19599859 ↗
• InjuryApr 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY TWO WEEKS POST-OPERATIVELY TO A CRYO ABLATION PROCEDURE, THE PATIENT LABS SHOWED HYPONATREMIA, HYPOKALEMIA, HYPOCALCEMIA, AND A SLIGHTLY ELEVATED WHITE BLOOD CELL (WBC) COUNT. AN ELECTROLYTE SUPPLEMENT WAS ADMINISTERED INTRAVENOUSLY TO THE PATIENT TO TREAT THE HYPOKALEMIA. DESPITE THE PATIENT BEING IN SINUS RHYTHM, THE PATIENT WAS CARDIOVERTED THE FOLLOWING DAY. THE PATIENT WAS ALSO HOSPITALIZED OVERNIGHT. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Atrial Flutter; High White Blood Cell Count; Hypocalcemia; Hypokalemia; Hyponatremia

  MAUDE report 19200660 ↗
• InjuryFeb 9, 2024Signal Artifact/Noise; Entrapment of Device; Detachment of Device or Device Component; Signal Artifact/Noise; Entrapment of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE INTEGRATED DILATOR/NEEDLE WAS NOT ABLE TO LOCK INTO THE SHEATH. THE DILATOR/NEEDLE WAS REPLACED WHICH RESOLVED THE ISSUE. AFTER THE FIRST ABLATION IN THE RIGHT SUPERIOR PULMONARY VEIN (RSPV), THE MAPPING CATHETER HAD A LOT OF NOISE. THE MAPPING CATHETER CABLE REPLACED, AND THEN THE PIN BLOCK WAS REPLACED WITHOUT RESOLUTION. THE PHYSICIAN ATTEMPTED TO REPOSITION THE MAPPING CATHETER AND IT WAS NOTED THAT IT DID NOT MOVE AT ALL. WHEN THE PHYSICIAN PULLED THE MAPPING CATHETER ALL THE WAY BACK, THE END OF MAPPING CATHETER REMAINED LODGED IN THE RIGHT SUPERIOR PULMONARY VEIN (RSPV). THE BALLOON CATHETER WAS REMOVED; A SNARE WAS INSERTED, AND THE END OF THE MAPPING CATHETER WAS SNARED, PULLED BACK INTO THE SHEATH, AND REMOVED. THE CASE WAS COMPLETED WITH CRYO. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Physical Entrapment

  MAUDE report 18680541 ↗
• MalfunctionJan 29, 2024Compatibility Problem; Material Deformation; Material Twisted/Bent; Compatibility Problem; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE MAPPING CATHETER WOULD NOT ADVANCE INTO THE BALLOON CATHETER GUIDEWIRE LUMEN. THE MAPPING CATHETER WAS DAMAGED. THE MAPPING CATHETER AND BALLOON CATHETER WERE REPLACED TO RESOLVE 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 18603434 ↗
• MalfunctionDec 21, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE MAPPING CATHETER HAD A KINK IN THE SHAFT. THE MAPPING CATHETER WAS REPLAC ED 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 18377874 ↗
• InjuryOct 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO DAYS FOLLOWING A SUCCESSFUL CRYO ABLATION PROCEDURE, THE PATIENT HAD ATRIAL FLUTTER WITH A RAPID VENTRICULAR RATE. A BLOOD TEST AND X-RAY WERE SUBSEQUENTLY PERFORMED, BOTH WITH NO CLINICALLY SIGNIFICANT RESULTS, AND THE PATIENT WAS HOSPITALIZED OVERNIGHT. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Atrial Fibrillation; Atrial Flutter

  MAUDE report 18027265 ↗
• InjuryOct 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS LATER REPORTED THAT THE MAPPING CATHETER WAS SUSPECTED TO HAVE PERFORATED THE LEFT SUPERIOR PULMONARY VEIN (LSPV). THE PATIENT REMAINED HOSPITALIZED, INTUBATED, AND STABLE TWO WEEKS FOLLOWING THE PROCEDURE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 17920051 ↗
• InjuryOct 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, FIRST AND ONLY FREEZE ON THE LEFT INFERIOR BRANCH OF THE LEFT COMMON VEIN, A POTENTIAL BLOOD CLOT WAS SUSPECTED DISTAL TO THE BALLOON INSIDE THE VEIN. THE FREEZE WAS CARRIED OUT. IMAGING WAS USED TO VERIFY IF THE CLOT WAS PRESENT BUT IT COULD NOT BE CONFIRMED. BLOOD THINNING MEDICATION WAS ADMINISTERED PRIOR TO THE TRANSEPTAL PUNCTURE AND AN ACTIVATED CLOTTING TIME (ACT) WAS ALSO COLLECTED BEFORE INSERTING THE BALLOON INTO THE LEFT ATRIUM. THE PATIENT REMAINED STABLE AND SHOWED NO SIGNS OF ST ELEVATION. THE CASE WAS COMPLETED WITH CRYO. THERE WAS NO EFFUSION POST ABLATION AND AGAIN THE IMAGE OF THE POTENTIAL BLOOD CLOT COULD NOT BE REPRODUCED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17875560 ↗
• MalfunctionSep 21, 2023Signal Artifact/Noise; Material Deformation; Material Twisted/Bent; Signal Artifact/Noise; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE ELECTRODES WERE REPORTEDLY DAMAGED AND SIGNAL ISSUES OCCURRED. THE MAPPING CATHETER WAS REPLACED TO RESOLVE 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 17788333 ↗
• InjuryAug 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A CRYO ABLATION PROCEDURE, THE PATIENT HAD POST OPERATIVE BLEEDING. THE PATIENT WAS KEPT OVERNIGHT FOR MONITORING. THE PATIENT MAINTAINED NORMAL SINUS RHYTHM (NSR) AND WAS DISCHARGED IN STABLE CONDITION. AFTER DISCHARGE, THE PATIENT RETURNED TO THE EMERGENCY ROOM (ER) FOR EVALUATION AS THE PATIENT REPORTEDLY FELL THREE TIMES AND AS A RESULT REPORTED A HEAD INJURY AND RIB PAIN. AN X-RAY WAS CARRIED OUT ON THE PATIENT AND NO MAJOR INJURIES WERE NOTED. THE PATIENT WAS FOUND TO BE ANEMIC WHICH REQUIRED TRANSFUSIONS AND HAD GUAIAC-POSITIVE STOOLS. IT WAS ALSO REPORTED THE PATIENT REPORTED INTERMITTENT HEMATOCHEZIA FOLLOWING A COLONOSCOPY APPROXIMATELY TWO WEEKS PRIOR TO THE CRYO ABLATION PROCEDURE. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Anemia; Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 17640713 ↗
• MalfunctionAug 25, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT PRIOR TO A CRYO ABLATION PROCEDURE, THE DISTAL END OF THE MAPPING CATHETER WAS DANGLING FREELY WHEN REMOVED FROM THE PACKAGING. UPON FURTHER INSPECTION, IT WAS REPORTED THAT THE MAPPING CATHETER WAS KINKED. THE MAPPING CATHETER WAS SUBSEQUENTLY REPLACED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17624859 ↗
• MalfunctionAug 18, 2023Compatibility Problem; Material Deformation; Material Twisted/Bent; Protective Measures Problem; Compatibility Problem; Material Deformation; Material Twisted/Bent; Protective Measures Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE ON THE LAST ABLATION, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION. IT WAS NOTED THERE WERE ISSUES RETRACTING THE CATHETER THROUGH THE MAPPING CATHETER. AFTER THE CATHETER AND MAPPING CATHETER WERE REMOVED FROM THE PATIENT, IT WAS OBSERVED THAT THE MAPPING CATHETER HAD MULTIPLE KINKS. BOTH THE CATHETER AND MAPPING CATHETER WERE REPLACED WHICH RESOLVED THE ISSUE. THE CASE WAS COMPLETED WITH CRYO. THE DATA FILE WERE REVIEWED AND CONFIRMED THE SYSTEM NOTICE. THE CONSOLE APPEARED TO BE CONTROLLING PRESSURE AND FLOW IN THE EXPECTED RANGES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17571437 ↗
• InjuryAug 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A "POTENTIAL" CLOT WAS OBSERVED IN THE LEFT ATRIUM VIA INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE CLOT WAS NOT PRESENT PRIOR TO TRANSEPTAL ACCESS AND THE PHYSICIAN WAS NOT SURE WHAT CAUSED THE CLOT. THE FIRST ABLATION WAS PERFORMED, AND THEN THE BALLOON CATHETER,  MAPPING CATHETER, AND SHEATH WERE REMOVED. THE BALLOON CATHETER AND SHEATH WERE FLUSHED AND ASPIRATED. THERE WAS NO SIGN OF A CLOT ON ANY OF THE PRODUCTS. THE ACTIVATED CLOTTING TIME WAS GREATER THAN FOUR HUNDRED SECONDS. ICE WAS UTILIZED AGAIN AND NO CLOT WAS OBSERVED. DESPITE THE CONCERNS, THE CASE WAS COMPLETED WITH CRYO. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17512369 ↗
• MalfunctionAug 9, 2023Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED A COMPROMISED OUTER VACUUM. THE BALLOON CATHETER WAS REPLACED TO RESOLVE THE ISSUE. ADDITIONALLY, THE MAPPING CATHETER WAS BENT WITH LITTLE PRESSURE DURING THE CASE. THE MAPPING CATHETER WAS REPLACED TO RESOLVE 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 17486100 ↗
• MalfunctionAug 1, 2023Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT PRIOR TO A CRYO ABLATION PROCEDURE, THE MAPPING CATHETER WAS KINKED WHEN INSERTING IT INTO THE BALLOON CATHETER. THE MAPPING CATHETER 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 17438139 ↗
• MalfunctionJul 26, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE TEMPERATURE WAS NOT AS EXPECTED SO A DOUBLE STOPPED WAS PERFORMED. IMMEDIATELY. A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION AND A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED BLOOD IN THE CATHETER HANDLE, THE INJECTION WAS STOPPED AND THE VACUUM DISABLED. IT WAS NOTED THAT THERE WAS BLOOD IN THE BALLOON CATHETER HANDLE AND IN THE CONSOLE VACUUM PORT. THE PROCEDURE WAS SWITCH TO RADIOFREQUENCY (RF) AND WAS COMPLETED WITH RADIOFREQUENCY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17401364 ↗
• InjuryJul 10, 2023Signal Artifact/Noise; Material Twisted/Bent; Signal Artifact/Noise; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, AFTER COMPLETING THE PULMONARY VEIN ISOLATION (PVI), THE BALLOON CATHETER AND MAPPING CATHETER WAS REMOVED FROM THE PATIENT AND THE SHEATH WAS POSITIONED TO THE RIGHT SIDE OF THE HEART TO THEN TREAT THE PATIENT'S PRE-EXISTING ATRIAL TACHYCARDIA STEMMING FROM THE SUPERIOR VENA CAVA (SVC). THE MAPPING CATHETER AND SHEATH WERE INSERTED INTO THE SVC TO MAP THE SVC. THE MAPPING CATHETER SIGNAL WERE NOISY. THE REPROCESSED MAPPING CATHETER CABLE WAS REPLACED WITHOUT RESOLVING THE ISSUE. THE SIGNAL DID NOT IMPROVE, AND THE MAPPING CATHETER WAS REMOVED FROM THE PATIENT. THE PATIENT WAS THEN SUCCESSFULLY MAPPED AND ABLATED USING ANOTHER MANUFACTURERS SYSTEM. THE CASE WAS COMPLETED WITH CRYO. AFTER THE CASE THE MAPPING CATHETER WAS INSPECTED AND TWO OF THE ELECTRODES WERE NOT IN THEIR EXPECTED POSITIONS BUT WERE INTACT AND THE LOOP WAS KINKED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17289957 ↗
• InjuryJun 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  2023-07-20: IT WAS LATER REPORTED THAT THE PATIENT HAD A RIGHT MIDDLE LUNG PULMONARY EMBOLISM. BLOOD AND URINE TESTS WERE PERFORMED. THE PATIENT WAS SUBSEQUENTLY GIVEN AN INTRAVENOUS ANTIBIOTIC MEDICATION, AN ANTIRHEUMATIC MEDICATION, AND ANTIPLATELET MEDICATION. THE PHYSICIAN SUSPECTS THE PULMONARY EMBOLISM OCCURRED POSSIBLY DUE TO PAUSING THE PATIENT'S ANTICOAGULANT FOR THE ABLATION PROCEDURE.

  Patient problems: Arrhythmia; Dyspnea; Fatigue; Muscle Weakness/Atrophy; Pulmonary Embolism

  MAUDE report 17142411 ↗
• MalfunctionMay 17, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE PHYSICIAN OPTED TO SWITCH FROM A LARGER BALLOON CATHETER TO A SMALLER BALLOON CATHETER. WHILE BEING REMOVED FROM THE FIRST BALLOON CATHETER, THE MAPPING CATHETER BENT AT A 90 DEGREE ANGLE AND LOOKED BROKEN. THE MAPPING CATHETER 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 16948038 ↗
• MalfunctionMay 17, 2023Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE MAPPING CATHETER WAS BENT AT THE "LASSO" END. WHEN THE MAPPING CATHETER WAS REMOVED FROM THE PACKAGE, IT WOULD NOT GO THROUGH THE INTRODUCER DUE TO THE BEND AND HOOK AT THE END OF IT. THE MAPPING CATHETER WAS REPLACED WHICH RESOLVED THE ISSUE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OFTHIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16947979 ↗
• MalfunctionMar 27, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT PRIOR TO A CRYO ABLATION PROCEDURE, THE MAPPING CATHETER WAS FOUND TO BE KINKED PRIOR TO ITS REMOVAL FROM ITS PACKAGING. A REPLACEMENT WAS REQUESTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16617673 ↗