IntellaNav Open-IrrigatedRecalls & reported problems across all models

We found 3 models of IntellaNav Open-Irrigated by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 59 adverse event reports in the FDA's MAUDE database, received between Dec 22, 2016 and Sep 28, 2020 — classified as 2 deaths, 11 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Temperature Problem” (13 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported IntellaNav Open-Irrigated problems

IntellaNav Open-Irrigated models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• IntellaNav™ Open-Irrigated M004R96200

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  39 reports
• IntellaNav™ Open-Irrigated M004R9620K20

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  2 deaths14 reports
• IntellaNav™ Open-Irrigated M004R9620N40

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  6 reports

Recent IntellaNav Open-Irrigated adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2020Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT A INTELLANAV OPEN-IRRIGATED WAS USED IN A ATRIAL TACHYCARDIA PROCEDURE. IT WAS NOTED THAT DURING THE PROCEDURE NOISY ELECTRODES OCCURRED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE WITH NO PATIENT COMPLICATIONS BEING REPORTED. HOWEVER ANALYSIS OF THE RETURNED DEVICE REVEALED TWO LEAKS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10594080 ↗
• 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 19, 2019Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT THE CATHETER TEMPERATURE WAS STUCK AT 20 DEGREES CELSIUS. DURING AN ABLATION PROCEDURE, WHEN THE INTELLANAV OPEN-IRRIGATED CATHETER WAS INSERTED INTO THE HEART, THE TEMPERATURE WAS DISPLAYED AT 20 DEGREES CELSIUS, SO THE CABLE WAS REPLACED. THE ISSUE DID NOT IMPROVE SO THE CATHETER WAS REPLACED, WHICH RESOLVED THE ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE NEW CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9090431 ↗
• 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 8, 2019Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT STEAM POP OCCURRED. DURING AN ABLATION FOR ATRIAL TACHYCARDIA IN THE RIGHT ATRIUM, A STEAM POP OCCURRED WITH THE INTELLANAV OPEN IRRIGATED CATHETER NEAR THE CORONARY SINUS OSTIUM. THE PATIENT'S BLOOD PRESSURE REMAINED NORMAL. THE SUSPECTED CAUSE WAS THAT THE PHYSICIAN WAS ABLATING ON THIS ANATOMY STRUCTURE. HIGH FLOW WAS SET FOR 30 WATTS OR MORE AND LOW FLOW FOR LESS THAN 30 WATTS. IMPEDANCE VALUES WERE UNKNOWN. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8875200 ↗
• 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 ↗

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