IntellaNav MiFi™ Open-Irrigated M004PMR9620N40Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 08714729938385), received between Feb 14, 2019 and Oct 22, 2025 — classified as 2 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (27 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 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2025Poor Quality Image; Adverse Event Without Identified Device or Use Problem; Poor Quality Image; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON SEPTEMBER 24, 2025. IT WAS REPORTED THAT NOISE SIGNAL INTERFERENCE OCCURRED INTERMITTENTLY. AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS USED FOR RADIOFREQUENCY ABLATION OF SUPRAVENTRICULAR TACHYCARDIA PROCEDURE IN THE ATRIOVENTRICULAR NODE. DURING THE PROCEDURE, A NOISE SIGNAL INTERFERENCE OCCURRED INTERMITTENTLY, AND IT AFFECTED POTENTIAL JUDGMENT. THE DEVICE WAS REPLACED AND COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS NOTED AS A RESULT OF THIS EVENT, AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED AN OBSTRUCTION ON THE DISTAL END WAS NOTED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23358833 ↗
• MalfunctionMay 14, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE DURING THE PROCEDURE TOTREAT ATRIAL FIBRILLATION (A FIB). IT WAS REPORTED THAT THE PHYSICIAN NOTICED FLUID LEAKING FROM THE PROXIMAL END OF THE ABLATION CATHETER WHEN THEY WERE MAPPING THE LEFT ATRIAL. THE CATHETER 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 19315286 ↗
• MalfunctionApr 12, 2024Poor Quality Image; Poor Quality Image

  THE COMPLAINT IS REPORTABLE UPON ANALYSIS. IT WAS REPORTED THAT A INTELLANAV MIFI OPEN-IRRIGATED DURING PROCEDURE FOR AN ATRIAL FIBRILLATION, AFTER APPROXIMATELY 30 MINUTES OF ABLATION, RADIOFREQUENCY (RF) DELIVERY BEGAN TO PRODUCE INTERMITTENT NOISE ON THE MIFI ELECTRODES. TO SOLVE THE ISSUE THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT COMPLICATIONS, THE MAPPING SYSTEM USED WAS THE HDX VERSION 4.6, NO ERROR MESSAGES SHOWED, THE PATIENT HAD AN IMPLANTABLE DEVICE, WHICH IS NOT SPECIFIED, AND THE FAILURE DID NOT OCCUR NEAR ANY SPECIFIC ANATOMY. IT WAS NOTED THAT THE PATIENT ALSO HAD A RESYNCHRONIZATION THERAPY PACEMAKER. THE INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS RETURNED FOR ANALYSIS. HOWEVER, DEVICE ANALYSIS FOUND THAT THE DEVICE FAILED THE FLOW TEST. THE DEVICE WAS CONNECTED TO A METRIQ PUMP AND WAS PURGED AT 60 ML/MIN. IRRIGATION PORTS DID NOT FLOW FREELY SINCE THE DEVICE WAS OBSTRUCTED DUE TO THE LUMEN WAS DAMAGED BY THE KINK IN THE SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102012 ↗
• MalfunctionApr 10, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE TO TREAT AN ATRIAL FIBRILLATION (AFIB), AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. AFTER APPROXIMATELY 10 MINUTES OF USE, IT WAS FOUND THAT FLUID WAS LEAKING FROM THE LUER CONNECTION ON THE PROXIMAL END OF THE CATHETER. NO ERROR MESSAGES WERE DISPLAYED. THE MAESTRO FLOW RATE WAS 17ML/MIN. THE CATHETER WAS REPLACED, AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT COMPLICATIONS. THE CATHETER HAS BEEN RECEIVED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19082395 ↗
• MalfunctionJan 30, 2024Fluid/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 (AFIB) AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. DURING ABLATION THE MAESTRO 4000 GENERATOR DISPLAYED THE ALARM D05 EXCESSIVE TEMPERATURE. IT WAS OBSERVED THAT THE LUER LOCK SECTION OF THE CATHETER WAS FRACTURED AND LEAKING FLUID. A METRIQ PUMP WAS IN USE AT THE TIME AND THE FLOW RATE WAS 17ML/MIN. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18606173 ↗
• MalfunctionJan 26, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  IT WAS REPORTED THAT DURING A RADIO-FREQUENCY ABLATION PROCEDURE USING AN INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER TO TREAT ATRIAL FIBRILLATION (A FIB) THE CATHETER'S IRRIGATION PORT WAS DAMAGED AND LEAKING. DURING INSERTION THE DAMAGE TO THE LUER PORT WAS IDENTIFIED AND THE LEAK WAS NOTED. THEY EXCHANGED THE CATHETER, AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS THEN COMPLETED WITH NO PATIENT COMPLICATIONS. THE CATHETER IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18587962 ↗
• MalfunctionJan 19, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE TO TREAT SUPER VENTRICULAR TACHYCARDIA (SVT) IN THE RIGHT ATRIUM, THE INTELLANAV MIFI OI CATHETER WAS SELECTED FOR USE. AFTER INSERTION OF THE CATHETER, THE LUER LOCK PORT BROKE OFF OF THE IRRIGATION PORT. THE CATHETER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18544150 ↗
• MalfunctionJan 9, 2024Device Displays Incorrect Message; Material Integrity Problem; Device Displays Incorrect Message; Material Integrity Problem

  IT WAS REPORTED THAT DURING A VENTRICULAR TACHYCARDIA PROCEDURE AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. IT WAS REPORTED THAT AT THE START OF RADIOFREQUENCY (RF) DELIVERY THE MAESTRO 4000 GENERATOR GAVE A "TEMPERATURE TOO HIGH ERROR" AND STOPPED DELIVERING RF. AT THIS TIME, IT WAS DISCOVERED THAT THE LUER CONNECTION ON THE ABLATION CATHETER HANDLE HAD DETACHED FROM THE CATHETER TUBING THAT COMES OUT OF THE CATHETER HANDLE. THE ABLATION CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS. THE DEVICE IS EXPECTED TO RETURN FOR LABORATORY ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18480163 ↗
• MalfunctionDec 8, 2023Fluid/Blood Leak; Device Displays Incorrect Message; Material Integrity Problem; Fluid/Blood Leak; Device Displays Incorrect Message; Material Integrity Problem

  IT WAS REPORTED THAT THE TUBING SET WAS FRACTURED AND LEAKING FLUID. IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE TO TREAT AN ATRIAL FIBRILLATION (AFIB), AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. METRIQ PUMP AND MAESTRO 4000 GENERATOR WERE IN USE. 17ML/MIN WAS THE FLOW RATE. AFTER 6 MINUTES OF ABLATION, THE GENERATOR ALARMED EXCESSIVE TEMPERATURE. THE LUER LOCK PORT ON THE CATHETER WAS NOTED TO BE FRACTURED AND LEAKING FLUID. CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT COMPLICATIONS. CATHETER IS EXPECTED TO BE RETURNED FOR FURTHER ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18296744 ↗
• MalfunctionNov 2, 2023Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  IT WAS REPORTED THAT AN INTELLANAV MIFI OI DURING PROCEDURE AFTER SEVERAL ABLATIONS, A FLUID LEAK WAS NOTICED FROM THE IRRIGATION PORT. 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 18057292 ↗
• MalfunctionOct 25, 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 A PREMATURE VENTRICULAR COMPLEX (PVC), AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. AFTER 3 MINUTES OF ABLATION, THE GENERATOR ALARMED EXCESSIVE TEMPERATURE. IT WAS NOTED THAT THE IRRIGATION PORT OF THE CATHETER WAS FRACTURED AND WAS LEAKING. CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT COMPLICATIONS. CATHETER WAS RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18004983 ↗
• MalfunctionOct 20, 2023Mechanics Altered; Mechanics Altered

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 25 SEPTEMBER 2023. IT WAS REPORTED THAT DURING A RADIOFREQUENCY ABLATION PROCEDURE TO TREAT ATRIAL FLUTTER (AF) AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. IT WAS NOTED WHILE INSIDE THE PATIENT ANATOMY, THAT THERE WAS DAMAGE TO THE CURVE PORTION OF THE CATHETER. THE CATHETER COULD NOT BEND PROPERLY. NO RESISTANCE WAS FELT WHILE MANEUVERING THE CATHETER. THE PATIENT DID NOT HAVE ANY UNUSUAL OR TORTUOUS ANATOMY. THE PHYSICIAN DID NOT USED SHEATHS, THE INCIDENT OCCURRED AFTER THE PACKAGING WAS UNPACKED. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT COMPLICATIONS. THE CATHETER WAS RETURNED FOR ANALYSIS. COMPLAINT WAS NOT CONFIRMED THROUGH CIS ANALYSIS FOR BAD/POOR CURVE. HOWEVER, A SECONDARY FINDING WAS OBSERVED WITH CUT IN THE CATHETER SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17976711 ↗
• MalfunctionJul 10, 2023Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING AN ABLATION PROCEDURE TO TREAT PREMATURE VENTRICULAR CONTRACTION, AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. IT WAS REPORTED THAT THE LUER TUBING OF THE CATHETER WAS DETACHED FROM THE CATHETER HANDLING. ALSO, FLUID WAS LEAKING FROM THE DISTAL END OF THE HANDLE. NO ERROR MESSAGES WERE DISPLAYED. THE CATHETER WAS REPLACED WITH ONE OF THE SAME MAKE AND MODEL AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT COMPLICATIONS. THE DEVICE IS EXPECTED TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17287282 ↗
• MalfunctionJun 15, 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 AN ATRIAL FIBRILLATION (AFIB), AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. MAESTRO 4000 AND METRIQ PUMP WERE IN USE. FLOW RATE WAS 17ML/MIN. DURING ABLATION THE LUER LOCK PORT OF THE IRRIGATION PORT ON THE ABLATION CATHETER BROKE OFF AND STARTED LEAKING BACK BLOOD FROM THE CATHETER. FLUID WAS LEAKING FROM THE IRRIGATION PORT OF THE CATHETER. THE GENERATOR ALARMED AND STATED EXCESSIVE TEMPERATURE. CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT COMPLICATIONS. CATHETER WAS RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17135814 ↗
• MalfunctionMay 1, 2023Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT PRIOR TO A PROCEDURE TO TREAT VENTRICULAR TACHYCARDIA (VT) AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. DURING SETUP OF THE CATHETER, IT WAS NOTED THAT INSUFFICIENT FLOW WAS COMING OUT OF THE CATHETER DURING FLUSHING. THE FLOW RATE WAS 60ML/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 16845406 ↗
• MalfunctionApr 11, 2023Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE TO TREAT A SUPRAVENTRICULAR TACHYCARDIA (SVT), AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. METRIQ PUMP AND MAESTRO 4000 GENERATOR WERE USED. 17ML/MIN WAS THE FLOW RATE. PRIOR TO FIRST ABLATION IT WAS NOTED THAT THE IRRIGATION PORT ON THE CATHETER WAS FRACTURED AND LEAKING FLUID. FLUID WAS LEAKING FROM WHERE THE LUER LOCK PORT CONNECTS TO THE SMALL PIGTAIL TUBING COMING FROM THE CATHETER HANDLE. NO ERROR MESSAGES WERE DISPLAYED. CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT COMPLICATIONS. CATHETER WAS RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16713853 ↗
• MalfunctionMar 30, 2023Fluid/Blood Leak; Device Displays Incorrect Message; Material Integrity Problem; Fluid/Blood Leak; Device Displays Incorrect Message; Material Integrity Problem

  CLINICAL STUDY INTERRUPT AF CLINICAL STUDY ID PM009, SUBJECT ID: (B)(6). IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE TO TREAT AN ATRIAL FIBRILLATION (AFIB), AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. A MAESTRO 4000 GENERATOR AND A METRIQ PUMP WERE ALSO IN USE. FLOW RATE WAS 17ML/MIN. DURING ABLATION, THE GENERATOR DISPLAYED A HIGH TEMPERATURE ERROR. THE CATHETER WAS INSPECTED; IT WAS FOUND THAT THERE WAS FLUID LEAKING FROM THE PROXIMAL END OF THE HANDLE AND THERE WAS A BREAK IN THE CATHETER IRRIGATION CONNECTION. CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT COMPLICATIONS. CATHETER WAS RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16644206 ↗
• MalfunctionMar 29, 2023Material Perforation; Material Perforation

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION (AFIB), AN INTELLANAV MIFI OI CATHETER WAS SELECTED FOR USE. DURING ABLATION THE CATHETER COULD NOT BE VISUALIZED ON THE RHYTHMIA HDX MAPPING SYSTEM. THE ABLATION CABLE WAS REPLACED, AND THIS DID NOT RESOLVE THE PROBLEM. THE ABLATION CATHETER WAS REPLACED AND THE PROBLEM WAS RESOLVED. UPON REMOVAL AND INSPECTION OF THE CATHETER A BREACH IN THE CATHETER SHAFT WAS FOUND. DURING THE PROCEDURE NO RESISTANCE FELT WHILE MANEUVERING THIS CATHETER. THE DAMAGE WAS NOT NOTICED BEFORE THE CATHETER WAS INSERTED INTO THE PATIENT. NO FRAGMENTS WERE LEFT IN THE PATIENT AND NO INTERVENTIONS WERE NEEDED TO RETRIEVE ANY PIECES OF THE DEVICE FROM INSIDE THE BODY. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT COMPLICATIONS. THE CATHETER HAS BEEN RETURNED FOR LABORATORY ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16637752 ↗
• MalfunctionMar 22, 2023Fluid/Blood Leak; Device Displays Incorrect Message; Fluid/Blood Leak; Device Displays Incorrect Message

  DURING PROCEDURE TO TREAT ATRIAL FIBRILLATION (A FIB), AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. IT WAS REPORTED THAT DURING ABLATION, THE GENERATOR DISPLAYED A HIGH TEMPERATURE ERROR. THE CATHETER WAS INSPECTED AND A DEFECT IN THE IRRIGATION PORT WAS FOUND. FLUID LEAKED FROM THE CATHETER'S HANDLE. CATHETER WAS REPLACED WITH ANOTHER OF SAME DEVICE AND PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. PRODUCT IS EXPECTED TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16590764 ↗
• MalfunctionMar 20, 2023Leak/Splash; Detachment of Device or Device Component; Temperature Problem; Leak/Splash; Detachment of Device or Device Component; Temperature Problem

  DURING PROCEDURE TO TREAT ATRIAL FLUTTER, AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. IT WAS REPORTED THAT DURING ABLATION THE GENERATOR ALARMED "EXCESSIVE TEMPERATURE" AND IT WAS NOTED THAT THE LUER LOCK CONNECTION WAS FRACTURED ON THE CATHETER AND ALSO LEAKING FLUID. CATHETER WAS REPLACED WITH ANOTHER OF DIFFERENT MODEL AND CASE PROCEEDED AND COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS REPORTED. PRODUCT HAS BEEN RETURNED AND ANALYSIS HAS BEEN PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16573449 ↗
• MalfunctionMar 9, 2023Material Integrity Problem; Material Integrity Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE A INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. BEFORE ANY ABLATION THE IRRIGATION PORT WAS DISCOVERED TO BE BROKEN AT THE LUER LOCK PORT. CATHETER WAS REPLACED AND CASE PROCEEDED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16514181 ↗
• MalfunctionJan 27, 2023Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING A PROCEDURE TO TREAT ATRIAL FIBRILLATION (A FIB) AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. DURING THE FIRST ABLATION THE GENERATOR ALARMED FOR A "HIGH TEMPERATURE" ERROR MESSAGE. IT WAS NOTED THAT THE THAT THE LUER LOCK CONNECTION OF THE IRRIGATION PORT ON THE CATHETER WAS FRACTURED AND LEAKING FLUID. A MAESTRO 4000 PUMP WAS IN USE AT THE TIME AND THE FLOW RATE WAS 17 ML/MIN. THE CATHETER WAS EXCHANGED FOR ANOTHER OF THE SAME MODEL AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16253384 ↗
• MalfunctionJan 17, 2023Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE TO TREAT AN ATRIAL TACHYCARDIA, AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. METRIQ PUMP & MAESTRO 4000 GENERATOR WERE USED. FLOW RATE WAS 17 ML/MIN. AFTER SEVEN MINUTES OF ABLATION, THE IRRIGATION PORT ON THE CATHETER FRACTURED AND STARTED LEAKING FLUID. A SMALL CRACK IN THE TUBING NEAR THE LUER LOCK CONNECTION WAS NOTICED AND FLUID WAS LEAKING FROM THE LUER LOCK CONNECTION TO THE TUBING ON THE CATHETER SIDE. EXCESSIVE TEMPERATURE ALARM WAS SEEN ON THE GENERATOR. CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT COMPLICATIONS. CATHETER IS EXPECTED TO BE RETURNED FOR FURTHER ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16184226 ↗
• MalfunctionNov 10, 2022Material Integrity Problem; Material Integrity Problem

  DURING CATHETER PREPARATION OF A PROCEDURE A INTELLANAV MIFI OPEN-IRRIGATED WAS SELECTED FOR USE. THE FLUID PORT DISCONNECTED FROM THE CATHETER TUBING ON PRODUCT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A CATHETER OF THE SAME MAKE AND MODEL AND THE PATIENT HAD NO ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15771485 ↗
• MalfunctionOct 19, 2022Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE TO TREAT AN ATRIAL FIBRILLATION (AFIB) ON THE RIGHT ATRIUM, AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. AFTER THE RIGHT ATRIUM MAP WAS COMPLETED AND BEFORE ANY ABLATION WAS PERFORMED, IT WAS NOTED THAT THE TUBING TO LUER LOCK CONNECTION WAS FRACTURED AND LEAKING FLUID. CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT COMPLICATIONS. CATHETER IS EXPECTED TO BE RETURNED FOR FURTHER ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15633306 ↗

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