IntellaNav MiFi™ Open-Irrigated M004PMR9620K20Recalls & reported problems

Summary

The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 08714729938378), received between Sep 12, 2018 and Dec 10, 2024 — classified as 9 injuries, 69 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (19 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 78 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2024Connection Problem; Connection Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2024. IT WAS REPORTED THAT DURING A LEFT SIDE BYPASS PROCEDURE, AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. ABOUT 30 MINUTES INTO THE PROCEDURE, THERE WAS IMPEDANCE AND POTENTIAL, HOWEVER THE CATHETER COULD NOT SHOW THE IMAGE. NO ERROR MESSAGES DISPLAYED. AFTER THE CATHETER WAS CONNECTED TO THE TAIL LINE, IT ENTERED THE VENTRICLE. THE IMPEDANCE AND POTENTIAL WERE NORMAL; HOWEVER, THE IMAGE COULD NOT BE SHOWN. THE CATHETER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. THE DEVICE WAS RETURNED FOR ANLAYSIS. DEVICE ANALYSIS REVEALED THAT THE DEVICE'S TIP HAD DETACHED/SEPARATED IN THE DISTAL END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20898719 ↗
• MalfunctionSep 16, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THE INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. IT WAS REPORTED THAT UPON OPENING THE BOX THEY OBSERVED A SMALL TEAR IN THE DEVICE PLASTIC PACKAGING RESULTING IN COMPROMISED STERILITY. THE DEVICE WAS REPLACED WITH A NEW ONE AND PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20233118 ↗
• MalfunctionJul 10, 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 A PROCEDURE TO TREAT AN ATRIAL FIBRILLATION (AFIB), AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. WHILE ATTEMPTING TO DELIVER RF ENERGY, THE GENERATOR GAVE A HIGH TEMP ERROR AND THE PHYSICIAN REALIZED THE FLUSH TUBING HAD SNAPPED OFF FROM THE CATHETER HANDLE AND STARTED LEAKING. THE DEVICE WAS REPLACED WITH A NEW CATHETER AND THE ISSUE WAS RESOLVED. PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT COMPLICATIONS. CATHETER IS NOT EXPECTED TO BE RETURNED SINCE IT WAS DISPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19712395 ↗
• MalfunctionApr 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DEVICE WAS RETURNED WITH NO REPORTED DEVICE FAILURE ALLEGATIONS. HOWEVER, WHEN THE DEVICE WAS RETURNED FOR ANALYSIS, PRODUCT INVESTIGATION SHOWED THAT THE DEVICE HAS A CUT IN THE SHAFT NEAR THE DISTAL END OF THE CATHETER. FUNCTIONAL TESTING SHOWED THAT THE STEERING KNOB AND THE TENSION CONTROL KNOB FUNCTIONED PROPERLY. NO ABNORMAL RESISTANCE WAS FELT WHEN ACTUATING THE STEERING MECHANISM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19193457 ↗
• MalfunctionJan 4, 2024Unsealed Device Packaging; Unsealed Device Packaging

  PRIOR TO A TYPICAL FLUTTER PROCEDURE AN INTELLANAV MIFI OPEN-IRRIGATED WAS SELECTED FOR USE. UPON PULLING THE SUPPLIES OUT AND IT WAS OBSERVE THAT THE SEAL ON THE PACKAGING WAS NOT STUCK DOWN MAKING THE PRODUCT NOT STERILE. AN EXCHANGE OF THE DEVICE RESOLVED THE ISSUE. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT COMPLICATIONS. THE DEVICE IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18448775 ↗
• MalfunctionJan 3, 2024Unsealed Device Packaging; Unsealed Device Packaging

  PRIOR TO A TYPICAL FLUTTER PROCEDURE AN INTELLANAV MIFI OPEN-IRRIGATED WAS SELECTED FOR USE. UPON PULLING THE SUPPLIES OUT AND IT WAS OBSERVE THAT THE SEAL ON THE PACKAGING WAS NOT STUCK DOWN MAKING THE PRODUCT NOT STERILE. AN EXCHANGE OF THE DEVICE RESOLVED THE ISSUE. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT COMPLICATIONS. THE DEVICE IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18435475 ↗
• MalfunctionNov 2, 2023Fluid/Blood Leak; Material Integrity Problem; Temperature Problem; Fluid/Blood Leak; Material Integrity Problem; Temperature Problem

  IT WAS REPORTED THAT AN INTELLANAV MIFI OI PRESENTED THE PORT OF THE CATHETER FRACTURED AND LEAKING FLUID, THE FRACTURE WAS LOCATED ON THE LUER LOCK PORT WHERE IT ATTACHES TO THE TUBING EXTENSION ON THE CATHETER SIDE. THIS WAS DISCOVERED WHEN THE MAESTRO 4000 ALARMED ABOUT AN EXCESSIVE TEMPERATURE DETECTED, THE FLOW RATE AT THE MOMENT WAS 17 ML PER MIN, A METRIQ PUMP WAS USED DURING THE PROCEDURE. TO SOLVE THE PROBLEM THE CATHETER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT COMPLICATIONS. THE REPORTED CATHETER HAS BEEN RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18056704 ↗
• MalfunctionNov 1, 2023Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT INSUFFICIENT IRRIGATION FLOW FROM CATHETER TIP WAS OBSERVED DURING PREPARATION OF THE CATHETER. THE INTELLANAV MIFI OPEN-IRRIGATED WAS SELECTED FOR USE DURING THE PROCEDURE TO TREAT SUPRAVENTRICULAR TACHYCARDIA. THE CATHETER WAS CONNECTED TO THE METRIQ PUMP AND FLUSHED AT 60ML/MIN AND IT WAS OBSERVED THAT THE SHOWER PATTERN AT THE IRRIGATION PORTS WAS ABSENT, AND IT APPEARED TO BE A CONSISTENT DRIP. SCRUB NURSE SWITCHED TO A SYRINGE TO ATTEMPT A TEMPORARY MANUAL FLUSH THEN OBSERVED A PROPER IRRIGATION. THE CATHETER WAS SWITCHED BACK TO METRIQ PUMP FOR IRRIGATION AND POOR IRRIGATION WAS AGAIN OBSERVED. CATHETER WAS REPLACED FOR A NEW ONE TO BEGIN PROCEDURE, WHICH IRRIGATED PROPERLY. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18047812 ↗
• MalfunctionOct 10, 2023Contamination; Packaging Problem; Contamination; Packaging Problem

  IT WAS REPORTED THAT A INTELLANAV MIFI OPEN-IRRIGATED HAD THE OUTER BOX AND THE INTERIOR PLASTIC BAG BENT AND KINKED, THE STERILE BARRIER MAY HAVE BEEN BROKEN. THIS CATHETER WAS NOT USED DURING ANY PROCEDURE AND NO PATIENT WAS INVOLVED. THE DEVICE IS EXPECTED TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17907716 ↗
• MalfunctionJun 21, 2023Contamination; Tear, Rip or Hole in Device Packaging; Contamination; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT PRIOR TO A MAPPING AND ABLATION PROCEDURE TO TREAT AN ATRIAL FLUTTER (AFL) AND ATRIAL FIBRILLATION (AF), AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. WHEN GETTING READY TO START A PROCEDURE AND PRODUCT WAS BEING PULLED, ITEMS WERE BEING REVIEWED WITH ANOTHER RMS AND ROUGH PLASTIC ON THE EDGES OF THE PACKAGING WAS FELT AS THE TWO DEVICES PULLED WERE PICKED UP. IT WAS THEN, UPON FURTHER INSPECTION THAT THE PACKAGING WAS VISIBLY NOTICED TO HAVE SMALL TEARS RENDERING THE PRODUCT UNSTERILE AND UNUSABLE. WHEN ADDITIONAL CATHETERS WERE PULLED, IT WAS NOTICED THAT SEVERAL OTHERS WERE TORN TOO. OTHER PRODUCTS THAT WERE STORED IN THE SAME PYXIS SYSTEMS WERE ALSO INSPECTED AND DID NOT FIND ANY OTHER PRODUCTS THAT HAD FLAWS. ULTIMATELY, THERE WERE TWO INTELLANAV CATHETERS STILL IN THE STORAGE AREA THAT WERE UNAFFECTED AND WAS ABLE TO USE ONE FOR THE PROCEDURE. PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT COMPLICATIONS. CATHETERS ARE EXPECTED TO BE RETURNED FOR FURTHER ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17175962 ↗
• MalfunctionJun 21, 2023Contamination; Tear, Rip or Hole in Device Packaging; Contamination; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT PRIOR TO A MAPPING AND ABLATION PROCEDURE TO TREAT AN ATRIAL FLUTTER (AFL) AND ATRIAL FIBRILLATION (AF), AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. WHEN GETTING READY TO START A PROCEDURE AND PRODUCT WAS BEING PULLED, ITEMS WERE BEING REVIEWED WITH ANOTHER RMS AND ROUGH PLASTIC ON THE EDGES OF THE PACKAGING WAS FELT AS THE TWO DEVICES PULLED WERE PICKED UP. IT WAS THEN, UPON FURTHER INSPECTION THAT THE PACKAGING WAS VISIBLY NOTICED TO HAVE SMALL TEARS RENDERING THE PRODUCT UNSTERILE AND UNUSABLE. WHEN ADDITIONAL CATHETERS WERE PULLED, IT WAS NOTICED THAT SEVERAL OTHERS WERE TORN TOO. OTHER PRODUCTS THAT WERE STORED IN THE SAME PYXIS SYSTEMS WERE ALSO INSPECTED AND DID NOT FIND ANY OTHER PRODUCTS THAT HAD FLAWS. ULTIMATELY, THERE WERE TWO INTELLANAV CATHETERS STILL IN THE STORAGE AREA THAT WERE UNAFFECTED AND WAS ABLE TO USE ONE FOR THE PROCEDURE. PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT COMPLICATIONS. CATHETERS ARE EXPECTED TO BE RETURNED FOR FURTHER ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17175955 ↗
• MalfunctionJun 21, 2023Contamination; Tear, Rip or Hole in Device Packaging; Contamination; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT PRIOR TO A MAPPING AND ABLATION PROCEDURE TO TREAT AN ATRIAL FLUTTER (AFL) AND ATRIAL FIBRILLATION (AF), AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. WHEN GETTING READY TO START A PROCEDURE AND PRODUCT WAS BEING PULLED, ITEMS WERE BEING REVIEWED WITH ANOTHER RMS AND ROUGH PLASTIC ON THE EDGES OF THE PACKAGING WAS FELT AS THE TWO DEVICES PULLED WERE PICKED UP. IT WAS THEN, UPON FURTHER INSPECTION THAT THE PACKAGING WAS VISIBLY NOTICED TO HAVE SMALL TEARS RENDERING THE PRODUCT UNSTERILE AND UNUSABLE. WHEN ADDITIONAL CATHETERS WERE PULLED, IT WAS NOTICED THAT SEVERAL OTHERS WERE TORN TOO. OTHER PRODUCTS THAT WERE STORED IN THE SAME PYXIS SYSTEMS WERE ALSO INSPECTED AND DID NOT FIND ANY OTHER PRODUCTS THAT HAD FLAWS. ULTIMATELY, THERE WERE TWO INTELLANAV CATHETERS STILL IN THE STORAGE AREA THAT WERE UNAFFECTED AND WAS ABLE TO USE ONE FOR THE PROCEDURE. PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT COMPLICATIONS. CATHETERS ARE EXPECTED TO BE RETURNED FOR FURTHER ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17175510 ↗
• MalfunctionMay 26, 2023Defective Device; Defective Device

  DURING PREPARATION OF PROCEDURE TO TREAT ATRIAL FIBRILLATION (A FIB), AN INTELLANAV MIFI OPEN-IRRIGATED WAS SELECTED FOR USE. IT WAS REPORTED WHEN PREPPING THE CATHETER AND SCREWING ON THE METRIQ TUBING, THE SIDE IRRIGATION PORT ON THE CATHETER FELL OFF. CATHETER WAS REPLACED WITH ANOTHER OF SAME DEVICE AND PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS REPORTED. PRODUCT IS NOT EXPECTED TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17013879 ↗
• MalfunctionApr 6, 2023Defective Device; Defective Device

  THE INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE DURING A PREMATURE VENTRICULAR CONTRACTIONS ABLATION PROCEDURE. IT WAS REPORTED THAT THE ERROR 'PURGE STOPPED PRESSURE LIMITED' ERROR WOULD REOCCUR ON THE PUMP WHILE TRYING TO PURGE THE CATHETER. THEY WERE UNABLE TO SUCCESSFULLY FLUSH THE CATHETER, THEREFORE, IT WAS REPLACED WITH A NEW ONE FROM THE DIFFERENT MODEL. THE PROCEDURE WAS THEN COMPLETED SUCCESSFULLY WITHOUT PATIENT COMPLICATIONS. THE DEVICE WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16690133 ↗
• MalfunctionFeb 20, 2023Fluid/Blood Leak; Device Displays Incorrect Message; Fluid/Blood Leak; Device Displays Incorrect Message

  THE INTELLANAV MIFI CATHETER OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE DURING AN ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION. IT WAS REPORTED THAT THE CATHETER'S FLUID PORT BROKE, AND FLUID LEAKED AT THE PROXIMAL END OF THE HANDLE WHICH TRIGGERED A HIGH TEMPERATURE ALERT TO OCCUR ON THE MAESTRO 4000 SYSTEM. THE CATHETER WAS REPLACED WITH ONE FROM THE SAME MODEL, HOWEVER, THE NEW CATHETER BROKE AS WELL. THE FLOW RATE WAS AT 30 MILLILITER PER MINUTE. THEY REPLACED THE CATHETER ONCE MORE. THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16404692 ↗
• MalfunctionFeb 20, 2023Fluid/Blood Leak; Device Displays Incorrect Message; Fluid/Blood Leak; Device Displays Incorrect Message

  THE INTELLANAV MIFI CATHETER OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE DURING AN ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION. IT WAS REPORTED THAT THE CATHETER'S FLUID PORT BROKE, AND FLUID LEAKED AT THE PROXIMAL END OF THE HANDLE WHICH TRIGGERED A HIGH TEMPERATURE ALERT TO OCCUR ON THE MAESTRO 4000 SYSTEM. THE CATHETER WAS REPLACED WITH ONE FROM THE SAME MODEL, HOWEVER, THE NEW CATHETER BROKE AS WELL. THE FLOW RATE WAS AT 30 MILLILITER PER MINUTE. THEY REPLACED THE CATHETER ONCE MORE. THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE HAS BEEN RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16404481 ↗
• MalfunctionJan 27, 2023Fluid/Blood Leak; Temperature Problem; Fluid/Blood Leak; Temperature Problem

  IT WAS REPORTED THAT DURING A RADIOFREQUENCY ABLATION PROCEDURE, AN INTELLANAV MIFI OI CATHETER WAS SELECTED FOR USE. DURING RADIOFREQUENCY ABLATION DELIVERY, THE ABLATION WAS STOPPED, AND A HIGH TEMPERATURE MESSAGE WAS OBSERVED. A POOL OF SALINE SOLUTION WAS FOUND AT THE HANDLE/LURE HUB CONNECTING TO THE METRIQ TUBING. A TEAR IN THE CATHETER TUBING WAS OBSERVED. THE CATHETER WAS THEN REPLACED, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT COMPLICATIONS. THE CATHETER WILL BE RETURNED FOR LABORATORY ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16253386 ↗
• MalfunctionNov 16, 2022Fluid/Blood Leak; Device Displays Incorrect Message; Detachment of Device or Device Component; Fluid/Blood Leak; Device Displays Incorrect Message; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE TO TREAT A PREMATURE VENTRICULAR COMPLEX (PVC) IN THE CORONARY SINUS (CS), AN INTELLANAV MIFI OPEN IRRIGATED CATHETER WAS SELECTED FOR USE. A MAESTRO 4000 SYSTEM & METRIQ PUMP WERE ALSO IN USE WITH A FLOW RATE OF 30 ML/MIN. WHEN NAVIGATING INTO THE CORONARY SINUS, ERROR MESSAGE D05 EXCESSIVE TEMPERATURE WAS DISPLAYED ON THE GENERATOR AND A LEAK WAS OBSERVED ON THE PROXIMAL END OF THE HANDLE AFTER THE FIRST ABLATION WAS STARTED IN THE VEIN. IRRIGATION TUBE WAS OBSERVED DETACHED. 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 15809977 ↗
• MalfunctionNov 10, 2022Fluid/Blood Leak; Defective Device; Fluid/Blood Leak; Defective Device

  IT WAS REPORTED THAT THE CATHETER LUER LOCK CONNECTION WAS FRACTURED AND WAS LEAKING FLUID. DURING A PROCEDURE TO TREAT ATRIAL FIBRILLATION (A FIB) AN INTELLANAV MIFI OI 7.5/110/2.5/4.5 K2 WAS SELECTED FOR USE. DURING ABLATION THE MAESTRO 4000 GENERATOR ALARMED AN "EXCESSIVE TEMPERATURE" WARNING. THE FLOW RATE WAS 17ML/MIN. WHEN THE CATHETER WAS INSPECTED AFTER THE ALARM IT WAS FOUND THAT THE LUER LOCK CONNECTION WAS FRACTURED AND LEAKING FLUID. THE CATHETER WAS EXCHANGED FOR ANOTHER OF THE SAME MODEL. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS. THE DEVICE HAS BEEN RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15771920 ↗
• MalfunctionNov 10, 2022Fluid/Blood Leak; Device Displays Incorrect Message; Fluid/Blood Leak; Device Displays Incorrect Message

  DURING AN ABLATION PROCEDURE TO TREAT ATRIAL ARRHYTHMIA, THE INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. IT WAS REPORTED THAT THEY HAD TWO CATHETERS WITH ISSUES. THE FIRST CATHETER HAD A STANDARD CURVE AND WAS USED FOR THE MAJORITY OF THE PROCEDURE UNTIL IT COULD NO LONGER BE STEERED. THE DEVICE HAD TO BE REPLACED WITH A NEW CATHETER THAT HAD A LARGE CURVE TO CONTINUE THE PROCEDURE. HOWEVER, AFTER USING THE SECOND CATHETER FOR A SHORT DURATION A D07 TEMPERATURE TOO HIGH ERROR OCCURRED ON THE MAESTRO. THE TIP WAS NOT BEING PROPERLY COOLED DURING RADIO FREQUENCY DELIVERY. THE CATHETER WAS INSPECTED, DAMAGE AND LEAKAGE WERE OBSERVED AT THE LUER HUB WHERE THE METRIQ TUBING SET WAS CONNECTED TO THE CATHETER. IT WAS NOTED THAT THE FLOW RATES WERE STANDARD FOR THE POWER SETTINGS. THE PHYSICIAN ATTEMPTED TO DELIVER A COUPLE OF ADDITIONAL 20WATT LESIONS WITHOUT HAVING THE TEMPERATURE CUT OFF. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITHOUT PERFORMING ANY TROUBLESHOOTING. NO PATIENT COMPLICATION WAS REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15771488 ↗
• MalfunctionNov 8, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE PREPARATION OF AN ABLATION PROCEDURE TO TREAT AN ATRIAL FLUTTER, AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. A MAESTRO 4000 GENERATOR AND METRIQ PUMP WERE ALSO IN USE WITH A FLOW RATE OF 30ML/MIN. CATHETER WAS TAKEN OUT OF THE PACKAGE AND DURING PREPARATION, LEAKING FROM PROXIMAL END OF TUBING WHERE IT GOES INTO THE HANDLE WAS NOTICED. NO ERROR WARNING WAS TRIGGERED. NO DAMAGE TO THE LUER WAS NOTICED. CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15752255 ↗
• MalfunctionSep 29, 2022Fluid/Blood Leak; Improper Flow or Infusion; Fluid/Blood Leak; Improper Flow or Infusion

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE WITH AN INTELLANAV MIFI OI CATHETER, A HIGH TEMPERATURE MESSAGE WAS OBSERVED ON THE MAESTRO GENERATOR AND THE ABLATION WAS STOPPED. THE CATHETER WAS REMOVED AND THERE WAS NOT ENOUGH IRRIGATION COMING FROM THE CATHETER PORTS. A PINHOLE ON THE IRRIGATION SIDE PORT OF THE CATHETER WAS SPRAYING FLUID. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT COMPLICATIONS. THE CATHETER IS EXPECTED TO BE RETURNED FOR LABORATORY ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15503921 ↗
• MalfunctionSep 14, 2022Material Integrity Problem; Material Integrity Problem

  REPORTABLE BASE ON ANALYSIS COMPLETED ON (B)(6) 2022. PRIOR TO A RADIOFREQUENCY ABLATION PROCEDURE A INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. THE SIGNAL WAS NOT STABLE. AN EXCHANGE OF THE CATHETER RESOLVE THE PROBLEM. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT COMPLICATIONS. HOWEVER, ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE IRRIGATION EXTENSION TUBING WAS FOUND PARTIALLY DETACHED/SEPARATED FROM THE LUER FITTING AT THE ADHESIVE JOINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15420435 ↗
• MalfunctionJul 18, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT DURING PREPARATION FOR A PROCEDURE TO TREAT REDO ATRIAL FLUTTER AND ATRIAL FIBRILLATION, A INTELLANAV MIFI OPEN-IRRIGATED CATHETER WAS HIGH FLOW FLUSHED (60ML/MIN). THE PHYSICIAN WAS UNHAPPY WITH THE FLOW OUT OF THE IRRIGATION PORTS. ONLY ONE OF THE PORTS WAS SPRAYING IN A JET AND THE REST EITHER WERE BLOCKED OR JUST BUBBLING SLOWLY. BUILDING PRESSURE WITH THE STOPCOCK CLOSED WAS PERFORMED WHILE PRIMING THE PUMP BUT WERE UNABLE TO CHANGE THE RESULTS, NO ERROR MESSAGES WERE DISPLAYED. THE CATHETER WAS EXCHANGED TO SOLVE THE ISSUE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT COMPLICATIONS. DEVICE IS EXPECTED TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15044107 ↗
• MalfunctionJul 12, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 15 JUN 2022. DURING THE ISCHEMIC VENTRICULAR TACHYCARDIA ABLATION, AN INTELLANAV MIFI OI CATHETER WAS SELECTED FOR USE. IT WAS REPORTED THAT THERE WAS NOISE AND STATIC ON ALL SURFACES AND INTRACARDIAC ELECTROGRAMS. THIS ISSUE OCCURRED WHILE MANIPULATING. THE CATHETER HAD INTERMITTENT VISIBILITY ON THE RHYTHMIA. THE MIFI OI CATHETER WAS REPLACED, AND THE CASE WAS SUCCESSFULLY COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. PRODUCT ANALYSIS REVEALED THERE WAS A FOREIGN MATERIAL IN THE DISTAL TIP AND IN THE FLOW. THE DEVICE PRESENTED A PARTIAL OBSTRUCTION IN SOME OF THE IRRIGATION HOLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14989546 ↗

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