IntellaNav™ Open-Irrigated M004R96200Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 08714729937432), received between Aug 2, 2017 and Apr 7, 2020 — classified as 7 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Temperature Problem” (12 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 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THERE WAS A FLUID LEAK AT THE BASE OF THE LEUR ADAPTER. DURING AN RADIO FREQUENCY ABLATION PROCEDURE TO TREAT PREMATURE VENTRICULAR CONTRACTIONS A INTELLANAV OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. WHEN THE CATHETER WAS PREPPED AND INSERTED, SOME ABLATIONS WERE PERFORMED AND BLOOD BLEED BACK WAS IN THE IRRIGATION TUBING. THE CATHETER WAS REMOVED AND FLUID LEAK WAS NOTICED AT THE BASE OF THE LEUR ADAPTER. AN EXCHANGE OF THE CATHETER RESOLVED THE ISSUE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9933441 ↗
• MalfunctionMar 23, 2020Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT THE CATHETER WAS SENSING TEMPERATURE LOWER THAN EXPECTED. DURING AN ABLATION PROCEDURE FOR TYPICAL FLUTTER, THE PHYSICIAN INSERTED THE INTELLANAV OPEN-IRRIGATED CATHETER INTO THE CHAMBER. DISTAL TEMPERATURE WAS ABOUT 31-32 DEGREE CELSIUS WITHOUT ABLATION. WITH ABLATION ENERGY ON AT 30 WATTS IN POWER CONTROL MODE, THE TEMPERATURE WAS ABOUT 19-20 DEGREE CELSIUS. THE PUMP FLOW SETTING WAS 25-30 ML/MIN. THE TEMPERATURE SENSOR WAS UNDER DETECTING. NO ERROR CODES WERE DISPLAYED. NO PATIENT COMPLICATIONS OCCURRED. THE PROCEDURE WAS COMPLETED WITH A NEW CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9865995 ↗
• MalfunctionMar 11, 2020Data Problem; Data Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 11FEB2020. IT WAS REPORTED THAT TRACKING/ACCURACY ISSUES OCCURRED. DURING AN ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION, AFTER SUCCESSFUL MAPPING, AN INTELLANAV OPEN-IRRIGATED CATHETER WAS ABLATING IN THE FEMORAL ARTERY WHEN THEY LOST MAGNETIC TRACKING. THE CATHETER DISAPPEARED IN RHYTHMIA. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THE BUTT BOND BETWEEN THE INSULATIONS OF THE DISTAL AND PROXIMAL SHAFTS WAS COMPROMISED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9817368 ↗
• MalfunctionJan 16, 2020Device Displays Incorrect Message; Communication or Transmission Problem; Temperature Problem; Device Displays Incorrect Message; Communication or Transmission Problem; Temperature Problem

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 23DEC2019. A INTELLANAV OI ABLATION CATHETER WAS SELECTED FOR A ABLATION PROCEDURE. HOWEVER DURING THE PROCEDURE THE CATHETER DISAPPEARED FROM THE SYSTEM AND THE GENERATOR DISPLAYED "FINDING CATHETER" ERROR AND THE TEMPERATURE DISAPPEARED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT CATHETER WHICH RESOLVED THE ISSUE WITH NO PATIENT COMPLICATIONS BEING REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED DAMAGED RING SEALS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9595850 ↗
• MalfunctionJan 7, 2020Poor Quality Image; Poor Quality Image

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 09DEC2019. IT WAS REPORTED THAT NOISE APPEARED ON THE 1-2 POTENTIALS, AND IT DISAPPEARED. THE INTELLA NAV OI WAS SELECTED FOR A ABLATION PROCEDURE. AFTER ABOUT 2 HOURS OF USE, NOISE SUDDENLY APPEARED ON THE 1-2 POTENTIALS AND DISAPPEARED. CABLE WAS REPLACED, BUT NOISE AND TRACKING DID NOT IMPROVE. THE ABLATION CATHETER WAS REPLACED, AND ABLATION WAS COMPLETED SUCCESSFULLY. HOWEVER, ANALYSIS REVEALED THAT THE DEVICE FAILED A LUMEN LEAK TEST, INDICATING A FLUID LEAK INSIDE THE SHAFT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9557671 ↗
• MalfunctionOct 28, 2019Failure to Deliver Energy; Power Conditioning Problem; Temperature Problem; Failure to Deliver Energy; Power Conditioning Problem; Temperature Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 03OCT2019. IT WAS REPORTED THAT NOISE AND HIGH TEMPERATURE ERRORS PREVENTED ABLATION. DURING A PERCUTANEOUS CATHETER MYOCARDIAL ABLATION PROCEDURE TO TREAT ATRIAL TACHYCARDIA, ENERGIZATION SUDDENLY STOPPED AS THE INTELLANAV OPEN-IRRIGATED CATHETER REACHED THE TEMPERATURE LIMIT WHEN THE LEFT ATRIUM WAS BEING ABLATED. A SUBSEQUENT HIGH TEMPERATURE ERROR MESSAGE APPEARED ON THE MAESTRO GENERATOR. AFTER RESOLVING THE ERROR, THE PHYSICIAN ATTEMPTED TO CONTINUE ABLATION, BUT SEVERE NOISE APPEARED ON THE DISTAL ELECTRODE UPON ENERGIZATION. THE TEMPERATURE LIMIT WAS ONCE AGAIN REACHED, AND ABLATION WAS HALTED AS THE ERROR MESSAGE REAPPEARED. THE CABLE WAS REPLACED, BUT THE ISSUE DID NOT RESOLVE. THE CATHETER WAS REPLACED, AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE NEW CATHETER, AND NO SERIOUS INJURY OR ADVERSE PATIENT EFFECTS OCCURRED. DEVICE ANALYSIS REVEALED EVIDENCE OF FLUID INGRESS THROUGH A CRACKED BUTT BOND SEAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9245897 ↗
• MalfunctionSep 23, 2019Power Conditioning Problem; Power Conditioning Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2019. IT WAS REPORTED THAT NOISE OCCURRED. DURING A PERCUTANEOUS CATHETER MYOCARDIAL ABLATION, AFTER PREPARATION OF THE INTELLANAV OPEN-IRRIGATED CATHETER WAS COMPLETED AND IT WAS INSERTED INTO THE BODY, NOISE APPEARED WHILE IN THE RIGHT INGUINAL. THE PROCEDURE COULD NOT BE PERFORMED WITH THE CATHETER AND THE PHYSICIAN DECIDED THE DEVICE COULD NOT BE USED SAFELY. A SECOND CATHETER WAS UNPACKED, AND BECAUSE NO NOISE APPEARED ON THE SECOND CATHETER, IT WAS USED TO COMPLETE THE ABLATION PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO ADVERSE PATIENT EFFECTS. HOWEVER, DEVICE ANALYSIS REVEALED IRRIGATION FLOWED THROUGH ONLY 5 PORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9107285 ↗
• MalfunctionSep 18, 2019Temperature Problem; Temperature Problem

  COMPLAINT REPORTABLE BASED ON ANALYSIS COMPLETED ON 21AUG2019. AN INTELLANAV OPEN-IRRIGATED CATHETER WAS SELECTED FOR AN ATRIAL TACHYCARDIA (AT) ABLATION PROCEDURE. THE CATHETER WAS INSERTED INSIDE THE BODY, BUT THEN THE TEMPERATURE DISPLAY BECAME 65 DEGREES AND ENERGIZATION COULD NOT BE PERFORMED. THE CABLE WAS REPLACED, BUT THE ISSUE WAS NOT RESOLVED. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME CATHETER. NO PATIENT COMPLICATIONS OCCURRED. HOWEVER, ANALYSIS REVEALED A LEAK IN THE COOLING LUMEN ALLOWED FLUID INGRESS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9084260 ↗
• MalfunctionSep 11, 2019Data Problem; Data Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 16AUG2019. IT WAS REPORTED THAT THE CURVE ON THE CATHETER WOULD NO LONGER DEFLECT. DURING AN ABLATION PROCEDURE FOR PREMATURE VENTRICULAR CONTRACTIONS, AN INTELLANAV OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. WHEN THE ABLATION WAS ALMOST FINISHED, THE ABLATION CATHETER BECAME UNABLE TO APPEAR ON THE RHYTHMIA. THE CABLE WAS REPLACED, BUT IT DID NOT IMPROVE, SO THE ABLATION CATHETER WAS REPLACED, AND IT APPEARED ON THE RHYTHMIA. THE ABLATION PROCEDURE WAS COMPLETED WITHOUT ISSUE. NO PATIENT COMPLICATIONS OCCURRED. HOWEVER, DEVICE ANALYSIS REVEALED THE MAGNETIC SENSOR WAS ELECTRICALLY SHORTED TO THE TIP (GND) DUE TO THE CONDUCTIVE NATURE OF BODY FLUID THAT ENTERED THE DISTAL END CAVITY THROUGH A DAMAGED BUTT BOND SEAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8992186 ↗
• MalfunctionSep 10, 2019Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT THE CATHETER HAD OCCLUDED IRRIGATION PORTS AND THERE WAS INSUFFICIENT IRRIGATION FLOW. DURING PREPARATION OF AN ABLATION PROCEDURE FOR ATRIAL TACHYCARDIA, A HIGH FLOW (60CC) WAS APPLIED WHILE PERFORMING AIR REMOVAL FOR THE INTELLANAV OPEN-IRRIGATED CATHETER. HOWEVER, THE FORCE OF THE RUNNING WATER WAS WEAKER THAN WAS EXPECTED AND WAS ONLY COMING OUT FROM ONE SIDE OF THE CATHETER. THE CATHETER WAS REMOVED FROM THE TUBING, AND FORCE FROM THE TUBING WAS CHECKED, BUT THERE WERE NO PROBLEMS OBSERVED. THE ALLEGED CATHETER WAS REPLACED, AND WHEN THE SAME PROCEDURE WAS PERFORMED WITH THE NEW CATHETER, IRRIGATION CAME OUT NATURALLY FROM THE IRRIGATION PORTS, SO THE NEW CATHETER WAS USED WITHOUT ANY FURTHER PROBLEMS. THE ABLATION PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO SERIOUS INJURY OR ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8982552 ↗
• MalfunctionAug 28, 2019Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT THERE WAS A DISCREPANCY WITH THE ACTUAL HEART TEMPERATURE. DURING AN ABLATION PROCEDURE FOR PREMATURE VENTRICULAR CONTRACTIONS (PVC), WHEN THE INTELLANAV OPEN-IRRIGATED WAS INSERTED INTO THE HEART (RIGHT AND LEFT VENTRICLE), THE TEMPERATURE WAS DISPLAYED AT ABOUT 20 DEGREES. THERE WAS A DISCREPANCY WITH THE ACTUAL HEART TEMPERATURE. THE ISSUE WAS PERSISTENT. TEMPERATURE SENSOR ISSUE WAS SUSPECTED. THEN, THE CATHETER WAS REPLACED WITH ANOTHER OF THE SAME CATHETER. WHEN IT WAS INSERTED INTO THE HEART, THE ACTUAL TEMPERATURE WAS DISPLAYED WITHOUT PROBLEMS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8941272 ↗
• MalfunctionAug 7, 2019Failure to Deliver Energy; Temperature Problem; Failure to Deliver Energy; Temperature Problem

  IT WAS REPORTED THAT THE CATHETER SHOWED HIGH TEMPERATURES. DURING AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION IN THE RIGHT ATRIUM, THE TEMPERATURE DISPLAY OF THE INTELLANAV OPEN-IRRIGATED CATHETER SUDDENLY SHOWED AN ABNORMAL VALUE OF 70 DEGREES CELSIUS DESPITE ENERGIZATION HAVING ALREADY BEEN PERFORMED SEVER TIMES, AND IT BECAME UNABLE TO FURTHER ABLATE. POWER MODE WAS USED WITH IRRIGATION SETTINGS AT -2ML/MIN AS IT WAS NOT THE TIMING OF APPLYING CURRENT AND THE CATHETER WAS IRRIGATED AT ALL TIMES WHILE INSIDE THE PATIENT. THE APPROACH WAS MADE WHILE MAKING A CURVE USING A DEFLECTABLE SHEATH AND THE CATHETER GOT BENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING THE CATHETER, AND NO PATIENT ISSUES OCCURRED. DEVICE ANALYSIS REVEALED THERE WAS EVIDENCE OF FLUID INGRESS THROUGH A CRACKED BUTT BOND SEAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8871163 ↗
• MalfunctionAug 7, 2019Material Perforation; Improper Flow or Infusion; Material Deformation; Positioning Problem; Temperature Problem; Material Perforation; Improper Flow or Infusion; Material Deformation; Positioning Problem; Temperature Problem

  IT WAS REPORTED THAT THE CATHETER TIP WAS KINKED, IRRIGATION WAS INSUFFICIENT, TEMPERATURE INCREASED, AND THE PROXIMAL MEMBRANE WAS TORN. DURING AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION IN THE LEFT AND RIGHT ATRIUM, IT WAS NOTICED THAT THE INTELLANAV OPEN-IRRIGATED CATHETER'S TIP SHAFT WAS KINKED. THE PHYSICIAN JUDGED THAT IT COULD STILL BE USED AND CONTINUED WITH THE PROCEDURE. THE IRRIGATION SETTINGS WERE 17ML/MIN IN POWER CONTROL MODE. THE CATHETER WAS IRRIGATED AT ALL TIMES WHILE INSIDE THE PATIENT. THE TEMPERATURE INCREASED WHEN ENERGIZATION WAS PERFORMED IN THE CORONARY SINUS (CS), AND ABLATION WAS UNABLE TO CONTINUE. WHEN INSERTING THE CATHETER INTO THE CS, MANIPULATION BECAME DIFFICULT. THE DEVICE WAS REMOVED FROM THE BODY, AND WHEN CHECKED, THE TWISTING OF THE TIP SHAFT HAD BECOME WORSE THAN WHEN IT WAS INSERTED, AND THE FLOW OF THE IRRIGATION WAS WORSE AS WELL. MOREOVER, SINCE THE PROXIMAL MEMBRANE WAS SLIGHTLY TORN, THE CATHETER WAS REPLACED WITH A NON-BOSTON SCIENTIFIC DEVICE. THE PROCEDURE WAS COMPLETED, AND NO PATIENT COMPLICATIONS OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8871142 ↗
• MalfunctionAug 6, 2019Improper Flow or Infusion; Temperature Problem; Improper Flow or Infusion; Temperature Problem

  IT WAS REPORTED THAT THERE WAS INSUFFICIENT IRRIGATION FLOW FROM THE CATHETER TIP. DURING A PERCUTANEOUS CATHETER MYOCARDIAL ABLATION PROCEDURE, DESPITE EARLIER PERFORMING AT AROUND 29-30 DEGREES CELSIUS, THE INTELLANAV OPEN-IRRIGATED WAS PERSISTENTLY CAUGHT AT THE TEMPERATURE LIMIT OF 42 DEGREES CELSIUS DURING ENERGIZATION IN POWER CONTROL MODE. THE FLOW RATE SETTING WAS 17/30ML/MIN AND HIGH FLOW SETTING OVER 31 WATTS. WHEN CHECKED, THERE WAS NO THROMBUS ADHERED. THE DEVICE WAS IRRIGATED AT ALL TIMES WHILE INSIDE THE PATIENT. WHEN FLUSHING WAS PERFORMED BY FAST FORWARD FROM THE METRIQ PUMP, IT WAS CONFIRMED THAT WATER ONLY CAME OUT OF 5 HOLES. THE PROCEDURE WAS COMPLETED WITH A SECOND CATHETER, AND THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8866500 ↗
• MalfunctionJul 24, 2019Power Conditioning Problem; Impedance Problem; Mechanics Altered; Temperature Problem; Data Problem; Power Conditioning Problem; Impedance Problem; Mechanics Altered; Temperature Problem; Data Problem

  IT WAS REPORTED THAT ABLATION EFFECT WAS UNABLE TO BE OBSERVED. DURING AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A INTELLANAV OPEN-IRRIGATED CATHETER, A SIGNIFICANT DRIFT ISSUE WAS OBSERVED AND A SLIGHT BASE NOISE APPEARED. POWER/CURRENT WAS SUPPLIED TO THE LEFT PULMONARY VEIN (LPV) RIDGE AT 35-40W WITH IRRIGATION FLOW 30ML/MIN. THERE WAS ALMOST NO CHANGE IN IMPEDANCE OR TEMPERATURE, MAKING IT DIFFICULT TO OBSERVE THE ABLATION. THE PHYSICIAN ALSO WANTED THE CATHETER TO BEND MORE FOR BETTER OPERABILITY. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS. IT WAS FURTHER REPORTED THAT THE ISSUE OCCURRED ABOUT AN HOUR INTO THE PROCEDURE. THERE WERE NO ERROR CODES DISPLAYED AND NO LOSS OF TEMPERATURE MONITORING FROM THE CATHETER. THE DEVICE WAS IN POWER MODE. IMPEDANCE DURING ABLATION WAS 120 +/- 5 OHMS (STANDBY 170-180 OHMS). THERE WERE NO TRACKING ISSUES, BUT ELECTRODES 1 AND 2 HAD SIGNAL NOISE. IT WAS NOTED THAT THIS WAS THE FIRST CASE OF THE DAY. THE PATIENT DID NOT HAVE ANY IMPLANTED DEVICES OR STENTS. THE C-ARM WAS IN USE NEAR THE PATIENT AND THE SOFTWARE HAD BEEN UPGRADED ON 17APR2019 TO LUMIPOINT VERSION 3.0. .

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8822153 ↗
• MalfunctionJul 24, 2019Power Conditioning Problem; Impedance Problem; Material Deformation; Mechanics Altered; Temperature Problem; Data Problem; Noise, Audible; Power Conditioning Problem; Impedance Problem; Material Deformation; Mechanics Altered; Temperature Problem; Data Problem; Noise, Audible

  IT WAS REPORTED THAT THE EFFECT OF THE ABLATION COULD NOT BE OBSERVED. THE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION. UPON UNPACKING THE INTELLANAV OI ABLATION CATHETER IT WAS OBSERVED TO BE KINKED AND WHEN BENDING IN BOTH DIRECTIONS AN AUDIBLE CRACK WAS HEARD AND THE CATHETER DID NOT BEND FAR ENOUGH. DURING THE PROCEDURE IN THE LEFT ATRIUM IT WAS FELT THAT THOUGH THERE WAS IRRIGATION, THE CATHETER TEMPERATURE WAS UNUSUALLY LOW AT 21 DEGREES C, AND THE IMPEDANCE SEEMED TO CHANGE LITTLE; THE EFFECT OF THE ABLATION COULD NOT BE FELT. THE DEVICE WAS IN POWER CONTROL MODE. SIGNAL NOISE WAS ALSO PRESENT, WHICH WAS IMPROVED BY IMPROVING THE POWER SUPPLY AROUND THE EQUIPMENT. MAGNETIC POSITIONING ALLOWED FOR SMALL CARDIAC VEIN ISOLATION AND THE PROCEDURE TO BE SUCCESSFULLY COMPLETED WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8821378 ↗
• MalfunctionJul 23, 2019Temperature Problem; Temperature Problem

  IT WAS REPORTED THE TEMPERATURE READING REMAINED CONSTANT DURING ABLATION. A INTELLA NAV OI WAS SELECTED FOR A ABLATION PROCEDURE. WHEN ABLATION WAS PERFORMED THE TEMPERATURE DISPLAYED REMAINED UNCHANGED AT 51 DEGREES FROM THE MIDWAY. EVEN IF THE CATHETER WAS TAKEN OUT OF THE HEART, THE TEMPERATURE DID NOT CHANGE. THERE WAS NO PROBLEM WITH THE IRRIGATION AND THERE WAS NO FOREIGN OBJECT ATTACHED/ADHERED TO THE TIP. IT WAS SUSPECTED THAT THE TEMPERATURE SENSOR IS DEFECTIVE. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8818270 ↗
• MalfunctionJul 23, 2019Low impedance; Impedance Problem; Low impedance; Impedance Problem

  IT WAS REPORTED THE EFFECT OF ENERGIZATION COULD NOT BE OBSERVED. DURING A ABLATION PROCEDURE WITH A INTELLANAV OPEN-IRRIGATED CATHETER, WHEN ENERGIZATION WAS PERFORMED THERE WAS NO LOSS OF POTENTIAL OBSERVED, AND THE IMPEDANCE DIDN'T DECREASE. THE EFFECT OF ENERGIZATION CANNOT BE OBSERVED. THE CATHETER HAD AN IMPEDANCE RANGE OF 99 - 96 OHMS. THERE WAS NO ERROR MESSAGE CONFIRMED. THE PROCEDURE WAS APPROXIMATELY 1 HOUR AFTER STARTING MAPPING WHEN THE ISSUE OCCURRED. AFTER REPLACING THE CATHETER WITH A NON-BSC CATHETER, IT WAS CONFIRMED THAT THERE WAS A SLIGHT EFFECT OF ENERGIZATION, AND THAT THE IMPEDANCE HAD DROPPED/DECREASED. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8818194 ↗
• MalfunctionMay 30, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A CATHETER LEAK OCCURRED. DURING AN ABLATION PROCEDURE FOR UNCOMMON ATRIAL FLUTTER, AN INTELLA NAV OI CATHETER WAS SELECTED FOR USE. THE CATHETER WAS INSERTED INTO THE LEFT ATRIUM. UPON MANIPULATION, WATER LEAKED FROM THE AREA NEAR THE PORT THAT CONNECTS THE SALINE FOR IRRIGATION. NO ERROR MESSAGES DISPLAYED ON THE MAESTRO GENERATOR. IT WAS SUSPECTED THAT THERE WAS A HOLE IN THE TUBE PART OF THE PORT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A NON-BOSTON SCIENTIFIC (BSC) REPLACEMENT DEVICE. NO SERIOUS INJURY OCCURRED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8654398 ↗
• MalfunctionMay 29, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A LEAK OCCURRED. A INTELLANAV OI WAS SELECTED FOR A PROCEDURE HOWEVER IT WAS OBSERVED DURING THE PROCEDURE THAT THE CATHETER WAS LEAKING AT THE IRRIGATION PORT. THE CATHETER WAS EXCHANGED FOR ANOTHER INTELLANAV OI. THE PROCEDURE WAS COMPLETED AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8649950 ↗
• MalfunctionMay 16, 2019Communication or Transmission Problem; Communication or Transmission Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED APRIL 22, 2019. IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE FOR PREMATURE VENTRICULAR CONTRACTIONS (PVC), THE INTELLANAV OI CATHETER WAS NO LONGER SENSED BY THE MAESTRO 4000 GENERATOR. THE MAESTRO POD. ABLATION BOX AND APPLICABLE CABLES WERE ALL REPLACED, TO NO EFFECT. A NEW INTELLANAV OI CATHETER WAS THEN USED WHICH SOLVED THE ISSUE. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BODY FLUID INGRESS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8615304 ↗
• MalfunctionApr 30, 2019Improper Flow or Infusion; Material Integrity Problem; Improper Flow or Infusion; Material Integrity Problem

  IT WAS REPORTED THAT INADEQUATE IRRIGATION OCCURRED. A INTELLANAV OI WAS SELECTED FOR AN ABLATION PROCEDURE. HOWEVER IT WAS NOTICED DURING PREPARATION THAT THE CATHETER'S IRRIGATION FLOW RATE WAS LOW AS OBSERVED BY ITS LOOKS. IT FLOWED AT LOW FLOW 2ML/MIN, BUT THERE WERE NO WATER DROPLETS CAME OUT. THE PHYSICIAN JUDGED THAT IT WAS DANGEROUS TO USE IN THIS STATE, SO THE DEVICE WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH NO SERIOUS INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8565129 ↗
• MalfunctionJan 9, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON DECEMBER 14 2019. IT WAS REPORTED THAT INCONSISTENT TRACKING OCCURRED. DURING A ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A INTELLANAV OI CATHETER POOR TRACKING WAS NOTED. THE DEVICE WOULD SHOW UP AND THEN IT WOULD DISAPPEAR CONSISTENTLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER INTELLANAV OI CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CURRENT CONDITION IS FINE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED FLUID INGRESS. VISUAL INSPECTION REVEALED THAT THE DISTAL END WAS BENT. DRIED BODY FLUID WAS FOUND ON THE HANDLE, MAIN BODY TUBING, AND DISTAL END. DRIED SALINE WAS FOUND ON THE DISTAL END AND INSIDE THE IRRIGATION PORTS. ELECTRICAL TESTS REVEALED NO ELECTRICAL SHORTS OR OPENS. ALL ELECTRODES, SENSOR, AND THERMOCOUPLE RESISTANCES MEASURED IN SPEC AND WERE TYPICAL. RESISTANCE AND INDUCTANCE MEASUREMENTS WERE INTERMITTENT AND THE MAGNETIC SENSOR WAS NOT WITHIN SPECIFICATIONS IN THE LEFT CURVE CONFIGURATION. NO ABNORMAL RESISTANCE WAS FELT WHEN ACTUATING THE STEERING MECHANISM. AFTER REMOVING THE THREE RING ELECTRODES, DRIED BODY FLUID WAS FOUND INSIDE THE RING 1 WIRE FEED THROUGH HOLE. AS THE TUBING WAS REMOVED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8232401 ↗
• MalfunctionJan 9, 2019Signal Artifact/Noise; Signal Artifact/Noise

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 11-DEC-2018 IT WAS REPORTED THAT NOISE OCCURRED. AN INTELLANAV OPEN-IRRIGATED CATHETER WAS SELECTED FOR A PREMATURE VENTRICULAR CONTRACTIONS (PVC) ABLATION PROCEDURE. DURING ABLATION NOISE WAS OBSERVED ON SIGNALS 1 AND 2. NO PATIENT COMPLICATIONS OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAV OI. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BLOCKED IRRIGATION PORTS. VISUAL INSPECTION REVELED DRIED BODY FLUID ALSO FOUND ON THE HANDLE AND MAIN BODY TUBING AS WELL AS DISTAL END AND INSIDE THE IRRIGATION PORTS. DRIED SALINE FOUND ON THE DISTAL END AND INSIDE THE IRRIGATION PORTS. ELECTRICAL CONTINUITY CHECKS REVEALED NO ELECTRICAL SHORTS OR OPENS, AS CHECKED MANUALLY USING A MULTI-METER AND BREAKOUT BOX. ALL ELECTRODES, SENSOR AND THERMOCOUPLE RESISTANCES MEASURED IN SPEC AND WERE TYPICAL. THE STEERING KNOB AND THE TENSION CONTROL KNOB FUNCTIONED PROPERLY ON BOTH LOCK AND UNLOCK POSITIONS. NO ABNORMAL RESISTANCE WAS FELT WHEN ACTUATING THE STEERING MECHANISM. ABLATION WAS VERIFIED BY USING A MAESTRO GENERATOR 4000, A METRIQ PUMP, AND A TANK OF 37C SALINE SOLUTION. HOWEVER, OCCLUSION ERRORS OCCURRED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8231423 ↗
• MalfunctionDec 20, 2018Failure to Deliver Energy; Device Displays Incorrect Message; Communication or Transmission Problem; Temperature Problem; Failure to Deliver Energy; Device Displays Incorrect Message; Communication or Transmission Problem; Temperature Problem

  REPORTABLE BASED ON ANALYSIS COMPLETED DECEMBER 5TH, 2018. AN INTELLANAV OI ABLATION CATHETER AND A MAESTRO GENERATOR WERE SELECTED FOR US DURING AN ABLATION PROCEDURE. THE CATHETER FAILED TO COMMUNICATE PROPERLY WITH THE GENERATOR. AFTER MAPPING, ATTEMPTS AT DELIVERING RF ENERGY WERE UNSUCCESSFUL DUE TO THE APPARENT COMMUNICATION FAULT. THE GENERATOR EITHER DISPLAYED TEMPERATURE OUT-OF-RANGE ERRORS, OR "LOCATING CATHETER" MESSAGES AFTER SEVERAL POWER CYCLES. THE CATHETER WAS EVENTUALLY REPLACED WITH A NEW CATHETER AND THE ISSUE RESOLVED. NO PATIENT COMPLICATIONS OCCURRED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A GAP AT THE BUTT BOND AND SUBSEQUENT BODY FLUID INGRESS. VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED A GAP BETWEEN THE DISTAL AND PROXIMAL SHAFTS AT THE BUTT BOND. THE GAP IS SLIGHTLY LESS THAN 1 MM WIDE, EXPOSING THE SUPPORT SLEEVE UNDER THE SHAFT INSULATION. THERE IS NO VISIBLE EVIDENCE OF ADHESIVE ON THE SUPPORT SLEEVE. A BEAD OF ADHESIVE WAS PRESENT AND CONTINUOUS AROUND THE CIRCUMFERENCE OF BOTH THE DISTAL AND PROXIMAL SHAFT ENDS. THERE WERE TWO KINKS LOCATED AT APPROXIMATELY 3CM AND 6CM FROM THE DISTAL END. THERE WAS DRIED BODY FLUID ON THE SUPPORT SLEEVE AT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8184384 ↗

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