IntellaNav MiFi™ Open-Irrigated M004PMR96200Recalls & reported problems

Summary

The FDA's MAUDE database contains 269 adverse event reports that list this exact device (DI 08714729938361), received between Sep 6, 2018 and Apr 14, 2025 — classified as 4 deaths, 54 injuries, 211 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (62 reports).

1 other recall cover devices cleared under the same FDA submission (P150005); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 269 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2025Fluid/Blood Leak; Improper Flow or Infusion; Material Integrity Problem; Fluid/Blood Leak; Improper Flow or Infusion; Material Integrity Problem

  IT WAS REPORTED THAT THE CATHETER WAS UNABLE TO FLUSH PROPERLY AND THE FLUSH PORT ON THE ABLATION CATHETER WAS BROKEN. DURING AN ABLATION PROCEDURE TO TREAT PAROXYSMAL ATRIAL FIBRILLATION AND ATRIOVENTRICULAR NODAL REENTRY TACHYCARDIA (AVNRT), AN INTELLANAV MIFI OPEN-IRRIGATED WAS SELECTED FOR USE. THE CATHETER WAS CONNECTED TO THE CATHETER CONNECTION CABLE AND METRIQ TUBING; HOWEVER, IT WAS OBSERVED THAT IT WAS UNABLE TO FLUSH PROPERLY. IT WAS NOTED THAT THE FLUSH PORT ON THE ABLATION CATHETER WAS BROKEN. ANOTHER OF THE SAME DEVICE WAS USED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21836773 ↗
• InjuryNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT EXPERIENCED A STROKE, CONFUSION, FEVER AND A FISTULA THAT REQUIRED ADDITIONAL SURGERY. ON (B)(6) 2024, A NAV MIFI OI CATHETER WAS SELECTED FOR A CARDIAC ABLATION PROCEDURE TO TREAT THE POSTERIOR WALL. ON (B)(6) 2024 THE PATIENT PRESENTED WITH A STROKE, CONFUSION, AND FEVER. COMPUTED TOMOGRAPHY (CT) IMAGING WAS PERFORMED AND CONFIRMED THAT AN ATRIO-ESOPHAGEAL (AE) FISTULA. SURGICAL INTERVENTION WAS PERFORMED TO REPAIR THE AE FISTULA. THE PATIENT HAS BEEN HOSPITALIZED FOR TREATMENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE WAS DISPOSED BY THE FACILITY AND WILL NOT BE RETURNED AS THE DEVICE PERFORMED AS EXPECTED DURING THE PROCEDURE AND THERE WERE NO REPORTS OF ANY PERFORMANCE CONCERNS.

  Patient problems: Confusion/ Disorientation; Fever; Fistula; Stroke/CVA

  MAUDE report 20710120 ↗
• InjuryNov 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED TACHYCARDIA & DISSECTION OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD) THAT REQUIRED STENTING. AN INTELLANAV MIFI OI CATHETER WAS SELECTED FOR A SUPRAVENTRICULAR TACHYCARDIA (SVT) ABLATION PROCEDURE. DURING MAPPING NEAR THE CORONARIES, A TACHYCARDIA WAS NOTICED WITH DECREASED LV FUNCTION AS SEEN ON IMAGING. THE NAV MIFI OI CATHETER WAS CATHETER WAS REMOVED, AND A DISSECTION WAS OBSERVED WITHIN THE LAD. THE DISSECTION WAS TREATED BY AN INTERVENTIONAL CARDIOLOGIST WITH STENT PLACEMENT. PATIENT WAS ADMITTED TO HOSPITAL BEYOND THE STANDARD OF CARE AND IS CURRENTLY RECOVERING.

  Patient problems: Tachycardia; Vascular Dissection

  MAUDE report 20663544 ↗
• MalfunctionNov 8, 2024Temperature Problem; Temperature Problem

  DURING RADIOFREQUENCY ABLATION OF ATRIAL FIBRILLATION PROCEDURE, A INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. IT WAS REPORTED THAT THE TEMPERATURE SENSOR OF THE DEVICE WAS DAMAGED, AND THE TEMPERATURE OF THE DEVICE IN THE BODY WAS ABNORMAL. NO ERROR MESSAGE WAS DISPLAYED. THE DEVICE HAS BEEN REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS. THE DEVICE WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20643385 ↗
• MalfunctionNov 7, 2024Temperature Problem; Temperature Problem

  DURING ABLATION PROCEDURE, A INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. IT WAS REPORTED THAT AN INACCURATE TEMPERATURE SENSING / UNABLE TO SENSE TEMPERATURE ISSUE OCCURRED. NO SPECIFIC ERROR MESSAGE WAS MENTIONED OR DISPLAYED. THE DEVICE HAS BEEN REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20634852 ↗
• MalfunctionSep 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE DURING THE PROCEDURE. IT WAS REPORTED THAT THE FLUSH PORT POPPED OFF MID-PROCEDURE. THE DEVICE WAS REPLACED AND PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT COMPLICATIONS. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20340290 ↗
• MalfunctionSep 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ONE INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS RETURNED WITHOUT A RELATED COMPLAINT RECORD. INVESTIGATION WAS PERFORMED ON DEVICE AND REVEALED THE TIP WAS OBSTRUCTED AFFECTING THE FLOW INSIDE OF THE DEVICE AS WELL AS THE TEMPERATURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20217643 ↗
• MalfunctionAug 21, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE INTELLANAV OPEN IRRIGATED CATHETER WAS SELECTED FOR USE DURING THE PROCEDURE TO TREAT ATRIAL FLUTTER. IT WAS REPORTED THAT 'D05-EXCESSIVE TEMPERATURE' ERROR APPEARED ON THE MAESTRO GENERATOR AFTER MAPPING AND ABLATION IN THE LEFT ATRIUM AND LEAKAGE WAS OBSERVED ON THE CATHETER'S IRRIGATION PORT AROUND THE TUBING. IT WAS NOTED THERE WAS NO DAMAGE ON THE LUER ITSELF. REPLACING THE CATHETER RESOLVED THE ISSUE. THE PROCEDURE WAS COMPLETED SUCCESFULLY WITHOUT PATIENT COMPLICATIONS. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20019580 ↗
• MalfunctionAug 14, 2024Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem; Data Problem; Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem; Data Problem

  IT WAS REPORTED THAT DURING A RADIO FREQUENCY ABLATION PROCEDURE TO TREAT A SUPRAVENTRICULAR TACHYCARDIA (SVT), AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. THE MAGNETIC SENSOR OF THE CATHETER MIGHT HAVE BEEN DAMAGED, ON THE SYSTEM THE CATHETER IMAGE WAS ABNORMAL, THE SIGNAL WAS UNSTABLE AND FINALLY WAS LOST, NO ERROR MESSAGES WERE DISPLAYED. PROCEDURE WAS UNABLE TO BE COMPLETED DUE TO THIS EVENT AND HAD TO BE CANCELLED/RESCHEDULED. NO PATIENT COMPLICATIONS WERE REPORTED. DEVICE IS EXPECTED TO BE RETURNED FOR FURTHER ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19982780 ↗
• MalfunctionJul 31, 2024Failure to Deliver Energy; Defective Device; Failure to Deliver Energy; Defective Device

  THE INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE DURING THE PROCEDURE TO TREAT PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA. IT WAS REPORTED THAT RADIOFREQUENCY ABLATION WAS NOT POSSIBLE DUE TO DEVICE FAILURE AND THE PROCEDURE WAS STOPPED. NO DAMAGE AND NO PATIENT COMPLICATIONS WERE NOTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19872207 ↗
• MalfunctionJul 18, 2024Improper Flow or Infusion; Temperature Problem; Improper Flow or Infusion; Temperature Problem

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE TO TREAT AN ATRIAL FLUTTER IN THE CAVOTRICUSPID ISTHMUS (CTI), AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. CATHETER PRESENTED IRRIGATION ISSUES AND HAD INACCURATE TEMPERATURE SENSING. CATHETER WAS TAKEN OUT OF THE BODY TO DOUBLE CHECK FLOW AND NOTHING WAS OCCLUDED. TRIED AGAIN AND GOT SAME ERROR. ALL PUMP SETTINGS WERE ON RIGHT; HOWEVER, PUMP WAS NOT INCREASING SPEED OF IRRIGATION WHEN ABLATION CAME ON. UNPLUGGED AND REPLUGGED ALL CONNECTIONS AND REPLACED THE PUMP; NEVERTHELESS, THE ISSUE PERSISTED. IT WAS DECIDED TO CHANGE THE IRRIGATED CATHETER FOR A INTELLANAV MIFI XP NON IRRIGATED CATHETER. AFTER THAT, A "SET POWER" ERROR WAS SEEN ON THE MAESTRO GENERATOR, EVEN THOUGH POWER WAS ALREADY SET. FINALLY, IT WAS DECIDED TO SWITCH OUT THE POD AND THAT RESOLVED THE PROBLEM. PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT COMPLICATIONS. CATHETER IS NOT EXPECTED TO BE RETURNED AS IT WAS DISPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19773851 ↗
• MalfunctionJun 3, 2024Communication or Transmission Problem; Communication or Transmission Problem

  THE INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE DURING THE PROCEDURE TO TREAT SUPRAVENTRICULAR TACHYCARDIA. IT WAS REPORTED THAT DURING THE PROCEDURE, THIS DEVICE HAD NO SIGNALS ON THE SYSTEM AND COULD NOT SHOW THE IMAGE. DUE TO THIS, THE PROCEDURE COULD NOT BE PERFORMED AND WAS CANCELLED. NO DAMAGE AND NO PATIENT COMPLICATIONS WERE NOTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. THE PATIENT WAS SEDATED AT THE TIME OF CANCELLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19448519 ↗
• MalfunctionMay 16, 2024Adverse Event Without Identified Device or Use Problem; Data Problem; Adverse Event Without Identified Device or Use Problem; Data Problem

  THE COMPLAINT IS REPORTABLE UPON INVESTIGATION RESULTS; IT WAS REPORTED THAT DURING A RADIOFREQUENCY ABLATION TO TREAT AN ATRIAL TACHYCARDIA ON THE LEFT ATRIUM, AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. THE CATHETER SHOOK SEVERELY AS SOON AS IT DISCHARGED. IT WAS FURTHER REPORTED THAT THE "SHOOK ISSUE" WAS A TRACKING/ACCURACY PROBLEM. NO PATIENT COMPLICATIONS OCCURRED. DEVICE WAS RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS. UPON DEVICE ANALYSIS, DEVICE WAS FOUND TO HAVE THE SHAFT PARTIALLY CUTTED/EXPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19332915 ↗
• MalfunctionMay 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE INTELLANAV MIFI CATHETER WAS SELECTED OR USE DURING THE PROCEDURE TO TREAT ATRIAL FIBRILLATION (A FIB). ONCE THE FLUSH TUBING WAS CONNECTED TO THE CATHETER, THE PHYSICIAN NOTICED THAT THE FLUSH TUBING HAD SNAPPED OFF THE CATHETER HANDLE, CONSEQUENTLY, HALTING IRRIGATION. THE CATHETER WAS REPLACED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT COMPLICATIONS. THE DEVICE WAS DISPOSED BY CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19324785 ↗
• InjuryApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL STUDY (B)(6) FOR INTERRUPT AF; SUBJECT ID: (B)(6) IT WAS REPORTED THAT FOLLOWING AN ABLATION PROCEDURE WITH AN INTELLANAV MIFI OPEN-IRRIGATED, THE PATIENT EXPERIENCED ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSES. THE PATIENT WAS EVALUATED AT OUTSIDE EMERGENCY ROOM AND AN ELECTROCARDIOGRAM (ECG) WAS PERFORMED. THE PATIENT'S HEART RATE WAS BETWEEN 160-180. DILTIAZEM 20 MG INTRAVENOUS (IV) BOLUS WAS ADMINISTERED AND CONVERTED TO NORMAL SINUS RHYTHM (NSR). THE PATIENT'S RHYTHM THEN CONVERTED BACK TO ATRIAL FIBRILLATION AND AN ADDITIONAL BOLUS DOSE OF DILTIAZEM 10 MG IV WAS ADMINISTERED. THE PATIENT REMAINED IN NSR. THE PATIENT WAS DISCHARGED WITH THE FOLLOWING MEDICATION CHANGES; TO STOP METOPROLOL TARTRATE AND INITIATE METOPROLOL SUCCINATE 200 MG DAILY. THE EVENT OUTCOME WAS LISTED AS ONGOING. IT IS UNKNOWN OF DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: Atrial Fibrillation

  MAUDE report 19043343 ↗
• MalfunctionFeb 21, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE INTELLANAV MIFI OPEN-IRRIGATED WAS SELECTED FOR USE DURING THE PROCEDURE TO TREAT INTRATRIOVENTRICULAR REENTRANT TACHYCARDIA. IT WAS REPORTED THAT DURING THE CATHETER PREPARATION IT WAS OBSERVED THAT THE CATHETER IRRIGATION WOULD NOT FLOW THROUGH. THEY ATTEMPTED TO USE A PUMP FOR CONTINUOUS FLUSH AS WELL AS A HAND INJECTION, BUT BOTH WERE INEFFECTIVE. IT WAS SUSPECTED THAT THE CATHETER INTERIOR WAS BLOCKED. NO DAMAGES WERE NOTED. A DIFFERENT DEVICE WAS USED FOR THE PROCEDURE. IT WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT COMPLICATIONS. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18751611 ↗
• MalfunctionFeb 8, 2024Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A RADIOFREQUENCY CARDIAC ABLATION PROCEDURE, AN INTELLANAV MIFI CATHETER WAS SELECTED FOR USE. THE CONSOLE PROMPTED THE CATHETER DID NOT CONNECT. CATHETER WAS REPLACED AS WELL AS THE RADIOFREQUENCY METER ACCESSORIES AND PROBLEM WAS RESOLVED, HOWEVER PROCEDURE WAS CANCELLED DUE TO THIS EVENT WHILE THE PATIENT WAS SEDATED WITH ANESTHESIA. THE DEVICE IS EXPECTED TO BE RETURNED FOR FURTHER ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18669308 ↗
• MalfunctionJan 25, 2024Defective Device; Defective Device

  DURING AN ATRIAL FLUTTER RADIOFREQUENCY ABLATION PROCEDURE, AN INTELLANAV MIFI WAS SELECTED FOR USE. THE ABLATION CATHETER ELECTRODE WAS DAMAGED, WHICH AFFECTED THE POTENTIAL COLLECTION. SIGNAL STATION SUDDENLY WAS DISCONNECTED DURING USE, AND REPEATED RESTART COULD NOT RESOLVE THE PROBLEM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT COMPLICATIONS. UPON RECEIPT OF THE CATHETER FOR INVESTIGATION AN OBSTRUCTION IN THE LUMEN WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18581320 ↗
• MalfunctionJan 16, 2024Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  DURING AN AFIB ABLATION PROCEDURE, AN INTELLANAV MIFI OI 7.5/110/2.5/4.5 STD WAS SELECTED FOR USE. IT WAS REPORTED THAT DURING THE ABLATION PROCEDURE, AN EXCESSIVE TEMP WARNING OCCURRED ON THE MAESTRO ABLATION GENERATOR AT THE START OF ABLATION. IT WAS NOTED THAT THE IRRIGATION TUBING ON THE ABLATION CATHETER WAS LEAKING FLUID, WHICH CAUSED THE TEMPERATURE ERROR. IT IS SUSPECTED THAT THE CATHETER TUBING WAS KINKED WHICH CAUSED THE LEAK TO OCCUR. THE CATHETER WAS REPLACED, AND PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED. THE DEVICE HAS BEEN RECEIVED AT BOSTON SCIENTIFIC POST MARKET LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18518664 ↗
• InjuryDec 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION USING AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER, AND PRIOR TO DISCHARGE, THE PATIENT EXPERIENCED PULMONARY INSUFFICIENCY WITH LOW OXYGEN SATURATION, NAUSEA, VOMITING, AND SEVERE HEADACHE. THE PATIENT WAS ADMINISTERED OXYGEN (O2) FOR THE DESATURATION, AND A CHEST X-RAY AND LABORATORY BLOOD TESTS WERE PERFORMED FOR DIAGNOSTICS. THE PATIENT WAS HOSPITALIZED FOR OBSERVATION OVER THE COURSE OF TWO DAYS, AFTER WHICH THE PATIENT RECOVERED FROM THE COMPLICATIONS AND WAS DISCHARGED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. IT WAS FURTHER REPORTED THAT THE SYMPTOMS OF NAUSEA AND VOMITING DID NOT OCCUR.

  Patient problems: Headache; Nausea; Respiratory Insufficiency; Vomiting

  MAUDE report 18388610 ↗
• MalfunctionDec 4, 2023Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  IT WAS REPORTED THAT AN INTELLANAV MIFI OPEN-IRRIGATED DURING PROCEDURE FOR A PULMONARY VEIN ISOLATION, THE PHYSICIAN WAS USING THE CATHETER FOR ONLY A FEW MINUTES, AND WHILE MANEUVERING FELT THAT THE IRRIGATION TUBING HAD SNAPPED OFF FROM THE PORT. THE BOSTON SCIENTIFIC SALES REPRESENTATIVE WITNESSED IT, THE PHYSICIAN WAS NOT PULLING ON THE CATHETER EXCESSIVELY OR WAS NOT BEING FORCEFUL. TO SOLVE THE ISSUE THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT COMPLICATIONS. THE DEVICE IS EXPECTED TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18262186 ↗
• InjuryNov 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL STUDY NAME INTERRUPT AF; CLINICAL STUDY ID (B)(6): SUBJECT ID: (B)(6). INDEX ABLATION PROCEDURE INVOLVING A INTELLIMAX MIFI OI ABLATION CATHETER WAS PERFORMED ON 01FEB2021. ON 03JUN2022, THE PATIENT EXPERIENCED SYMPTOMATIC ATRIAL FIBRILLATION (AE1). PATIENT WAS ADMITTED INTO THE HOSPITAL AND WAS ADMINISTERED DOFETILIDE ORAL MEDICATION. ISSUE WAS RESOLVED 07JUN2022. ON 06MAR2023, THE PATIENT AGAIN EXPERIENCED ATRIAL FIBRILLATION REOCCURRENCE (AE2). THE PATIENT WAS IMPLANTED AN EP LOOP RECORDER IMPLANT (ILR). DURING ILR MONITORING, RECURRENCE OF AFIB WITH 20-30% BURDEN WAS FOUND. PATIENT UNDERWENT A REPEAT AFIB ABLATION PROCEDURE TO RESOLVE THE ADVERSE EVENT, NO ISSUES WERE FURTHER NOTED AND PATIENT WAS DISCHARGED ON 07MAR2023.

  Patient problems: Atrial Fibrillation

  MAUDE report 18194749 ↗
• InjuryNov 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL STUDY NAME INTERRUPT AF; CLINICAL STUDY ID (B)(6): SUBJECT ID: (B)(6) INDEX ABLATION PROCEDURE INVOLVING A INTELLIMAX MIFI OI ABLATION CATHETER WAS PERFORMED ON (B)(6) 2021. ON (B)(6) 2022, THE PATIENT EXPERIENCED SYMPTOMATIC ATRIAL FIBRILLATION (AE1). PATIENT WAS ADMITTED INTO THE HOSPITAL AND WAS ADMINISTERED DOFETILIDE ORAL MEDICATION. ISSUE WAS RESOLVED (B)(6) 2022. ON (B)(6) 2023, THE PATIENT AGAIN EXPERIENCED ATRIAL FIBRILLATION REOCCURRENCE (AE2). THE PATIENT WAS IMPLANTED AN EP LOOP RECORDER IMPLANT (ILR). DURING ILR MONITORING, RECURRENCE OF AFIB WITH 20-30% BURDEN WAS FOUND. PATIENT UNDERWENT A REPEAT AFIB ABLATION PROCEDURE TO RESOLVE THE ADVERSE EVENT, NO ISSUES WERE FURTHER NOTED AND PATIENT WAS DISCHARGED ON (B)(6) 2023.

  Patient problems: Atrial Fibrillation

  MAUDE report 18193093 ↗
• MalfunctionNov 20, 2023Fluid/Blood Leak; Device Displays Incorrect Message; Material Integrity Problem; Fluid/Blood Leak; Device Displays Incorrect Message; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. DURING RADIOFREQUENCY (RF) ABLATION THE MAESTRO GENERATOR DISPLAYED AN EXCESSIVE TEMPERATURE ALARM. WHEN THE CATHETER WAS CHECKED IT WAS FOUND THAT THE IRRIGATION PORT WAS BROKEN AND THE IRRIGATION FLUID WAS LEAKING FROM THE TUBING. A METRIQ PUMP WAS USED FOR IRRIGATION WITH A FLOW RATE OF 30ML/MIN. THE CATHETER WAS REPLACED WITH ANOTHER OF THE SAME MODEL. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18172008 ↗
• MalfunctionNov 14, 2023Poor Quality Image; Poor Quality Image

  THE COMPLAINT IS REPORTABLE FOR MALFUNCTION PER PRODUCT INVESTIGATION RESULTS; IT WAS REPORTED THAT THERE WAS A SIGNIFICANT MICROELECTRODE SIGNAL INTERFERENCE. DURING A PROCEDURE TO TREAT SUPRAVENTRICULAR TACHYCARDIA (SVT) AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. IT WAS NOTED THAT THERE WAS SIGNIFICANT MICROELECTRODE SIGNAL INTERFERENCE IN ELECTRODES 1-2. THE NOISE DID NOT IMPROVE OVER THE DURATION OF THE ABLATION, WITH REPEAT ABLATIONS, OR WITH PACING. NO ERROR MESSAGES DISPLAYED. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT COMPLICATIONS. THE CATHETER WAS RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS. UPON DEVICE ANALYSIS, IT WAS FOUND DURING THE FLOW TEST THAT THE DEVICE WAS OCCLUDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18130046 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P150005. One submission often covers many models, so check the product and lot details in each record.

• Z-0699-2019 · Nov 28, 2018 · Open, Classified
  Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump