IntellaTip MiFi XPRecalls & reported problems across all models

We found 4 models of IntellaTip MiFi XP by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 40 adverse event reports in the FDA's MAUDE database, received between Dec 8, 2016 and Jul 16, 2024 — classified as 2 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 IntellaTip MiFi XP problems

IntellaTip MiFi XP models

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

• IntellaTip MiFi™ XP M004PM4500K20

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  18 reports
• IntellaTip MiFi™ XP M004PM45000

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  9 reports
• IntellaTip MiFi™ XP M004PM4790K20

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  8 reports
• IntellaTip MiFi™ XP M004PM47900

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

Recent IntellaTip MiFi XP adverse event reports

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

• MalfunctionJul 16, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A PAROXYSMAL ATRIAL FIBRILLATION (PAF), AN INTELLATIP MIFI XP CATHETER WAS SELECTED FOR USE. AFTER SEVERAL INSTANCES OF ENERGIZING, THE CATHETER TIP BECAME DEFORMED DUE TO HEAT DAMAGE, MAKING IT DIFFICULT TO MAINTAIN PROPER CONTACT. CATHETER WAS REPLACED 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 DISCARDED AT FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19756422 ↗
• InjuryApr 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CATHETER TIP DETACHED FROM THE REST OF THE CATHETER AND WAS UNABLE TO BE RETRIEVED, WHICH REQUIRED A SURGICAL INTERVENTION. PER LITERATURE REVIEW, IT WAS REPORTED THAT: A 52-YEAR-OLD MAN TREATED WITH PREVIOUS MECHANICAL MITRAL VALVE REPLACEMENT PRESENTED TO AN OUTSIDE HOSPITAL FOR PLANNED CARDIAC ABLATION FOR ATRIAL FIBRILLATION (AF) USING AN INTELLATIP MIFI XP ABLATION CATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE INTELLATIP ABLATION CATHETER ACROSS THE MECHANICAL MITRAL VALVE, THE CATHETER WAS SHEARED, LEAVING THE DISTAL TIP INTRAVASCULARLY AND UNABLE TO BE RETRIEVED. HE WAS EMERGENTLY TRANSFERRED TO THE ADVOCATE HEALTH CARE FACILITY, UNITED STATES, FOR FURTHER WORKUP AND TREATMENT. ON ARRIVAL, WORKUP INCLUDING CHEST X-RAY, ABDOMINAL X-RAY AND NECK X-RAY FAILED TO REVEAL THE RETAINED CATHETER TIP. THEREFORE, A SKULL X-RAY WAS PERFORMED AND THEN CONFIRMED WITH HEAD COMPUTED TOMOGRAPHY (CT) SHOWING THE CATHETER TIP PRESENT IN THE RIGHT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY. THE PATIENT ARRIVED NEUROLOGICALLY INTACT WITH ONLY SYMPTOMS OF A MILD HEADACHE. DUE TO CONCERNS OF DEVELOPING A LARGE VESSEL OCCLUSION, PATIENT WAS EMERGENTLY TAKEN TO THE NEUR

  Patient problems: Headache

  MAUDE report 19041723 ↗
• MalfunctionOct 27, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BEFORE A PROCEDURE AN INTELLATIP MIFI XP CATHETER WAS SELECTED FOR USE, HOWEVER, THE DEVICE WAS FOUND CONTAMINATED WITH A FOREIGN SUBSTANCE. THE FOREIGN MATERIAL WAS CONTAINED INSIDE THE STERILE BARRIER. THE FOREIGN MATERIAL WAS LOOSE. IT WAS DECIDED TO REPLACE THE DEVICE, AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE WAS RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18021082 ↗
• MalfunctionOct 17, 2022Temperature Problem; Temperature Problem

  DURING PROCEDURE, AN INTELLATIP MIFI XP CATHETHER WAS SELECTED FOR USE. IT WAS REPORTED THAT THE TEMPERATURE COULD NOT BE DETECTED. AFTER CATHETER WAS INSERTED, ENERGIZATION WAS STARTED AT 50W55 DEGREES SETTING, BUT TEMPERATURE REMAINED AT 36 DEGREES, AND IT DID NOT INCREASE. CATHETER WAS APPLIED AND GENERATOR WAS RESTARTED, BUT THERE WAS NO IMPROVEMENT, SO THE CATHETER WAS REPLACED, AND IT IMPROVED. PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. PRODUCT IS NOT EXPECTED TO BE RETURNED AS IT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15618922 ↗
• MalfunctionAug 24, 2022Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT WHILE USING AN INTELLANAV MIFI XP CATHETER, LOW TEMPERATURES WITH AN AVERAGE AROUND 20 C OCCURRED. NO ERROR MESSAGES OR ALERTS WERE NOTED. PROCEDURE WAS COMPLETED AND NO PATIENT COMPLICATIONS WERE REPORTED. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022 ISSUE OCCURRED WHEN THE PHYSICIAN WAS ON ABLATION. THE TEMPERATURE ROSE TO THE TEMP LIMITER WHICH RESULTED IN LOW WATTAGE. THE GENERATOR WAS IN TEMPERATURE MODE. THE PHYSICIAN MOVED TO DIFFERENT POSITIONS TO TRY AND ESTABLISH BETTER COOLING. NO OTHER TROUBLESHOOTING WAS DONE. THE PHYSICIAN SWITCHED TO AN IRRIGATED OPEN IRRIGATED CATHETER. DEVICE WAS DISPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15287137 ↗
• MalfunctionJun 13, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING PREPARATION FOR A PROCEDURE USING A INTELLATIP MIFI XP CATHETER THERE WAS FOREIGN MATERIAL INSIDE THE STERILE PACKAGING. THEY REPLACED THE CATHETER AND WERE ABLE TO COMPLETE THE PROCEDURE WITHOUT PATIENT COMPLICATIONS. THE CATHETER IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14676218 ↗
• InjuryNov 3, 2021Noise, Audible; Noise, Audible

  DURING A CAVO-TRICUSPID ISTHMUS (CTI) LINE ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION A INTELLATIP MIFI XP CATHETER WAS SELECTED FOR USE. THE SYSTEM WAS OPERATING AT DEFAULT SETTINGS AND THE TEMPERATURE CONTROL WAS AT 70 WATTS AND 65 DEGREES. AFTER CTI BLOCK WAS CONFIRMED, IT WAS REPORTED THAT A STEAM POP OCCURRED DURING THE EXTRA ABLATION INSIDE THE CTI INFERIOR VENA CAVA. CARDIAC TAMPONADE WAS ALSO OBSERVED. THE PROCEDURE WAS COMPLETED WITH TREATMENT.

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Low Blood Pressure/ Hypotension; Necrosis; Pericardial Effusion

  MAUDE report 12747290 ↗
• MalfunctionJun 21, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A FOREIGN OBJECT WAS FOUND INSIDE THE STERILIZATION BAG AFTER UNPACKING THE BOX CONTAINING THE INTELLATIP MIFI CATHETER. WHEN THE BAG WAS CHECKED CLOSELY, THERE WERE PLASTIC PIECES FOUND. SINCE THE COATING OF THE MAIN UNIT HANDLE PEELED OFF, IT IS POSSIBLE THAT IT WAS PART OF THE PLASTIC PIECES. NO PATIENT COMPLICATIONS WERE REPORTED. A DIFFERENT CATHETER WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12032055 ↗
• MalfunctionJun 4, 2019Communication or Transmission Problem; Communication or Transmission Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20MAY2019. IT WAS REPORTED THE CATHETER COULD NOT BE RECOGNIZED. DURING AN ABLATION PROCEDURE WITH AN INTELLATIP MIFI XP CATHETER WHEN THE ABLATION CATHETER WAS PLACED IN THE HEART, THE CATHETER COULD NOT BE RECOGNIZED. RECOGNITION WAS IMPROVED BY CHECKING THE CONNECTION AND STARTING UP THE EQUIPMENT, BUT IMPEDANCE WAS HIGH, AND ENERGIZATION COULD NOT BE PERFORMED. CONNECTION CHECKING, EQUIPMENT STARTING UP, AND CONNECTION CABLE REPLACEMENT WERE PERFORMED, BUT THE ISSUE WAS NOT RESOLVED. IT WAS REQUESTED TO REPLACE TO ABLATION CATHETER, BUT SINCE IT ALREADY TOOK TIME, THE PHYSICIAN TOLD TO PERFORM THE PROCEDURE USING NON-BSC SYSTEM ABLATION CATHETER, AND THAT WAS FOLLOWED. NO PATIENT COMPLICATIONS WERE REPORTED. DEVICE ANALYSIS REVEALED RINGS WERE INSPECTED AND RING #1 SEAL WAS FOUND COMPROMISED SINCE BROKEN ADHESIVE WAS OBSERVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8666177 ↗
• MalfunctionMar 14, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A BLACK FOREIGN OBJECT WAS FOUND INSIDE THE STERILE CATHETER PACKAGING. DURING PREPARATION FOR AN ATRIAL FLUTTER ABLATION PROCEDURE, A BLACK FOREIGN OBJECT WAS FOUND INSIDE THE STERILE CATHETER PACKAGING. THE DEVICE WAS NOT USED FOR THE PROCEDURE AND ANOTHER OF THE SAME CATHETER WAS USED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CURRENT CONDITION IS FINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8420025 ↗
• MalfunctionAug 15, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A STEAM POP OCCURRED. A INTELLATIP MIFI XP WAS USED IN A SUPRAVENTRICULAR TACHYCARDIA ABLATION. ON THE THIRD ABLATION DELIVERY THE PHYSICIAN EXPERIENCED A STEAM POP. PROCEDURE WAS COMPLETED USING THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7784098 ↗
• MalfunctionJun 12, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED FOREIGN MATERIAL WAS FOUND INSIDE THE STERILE PACKAGE. DURING PREPARATION OF THE INTELLATIP MIFI¿ XP ABLATION CATHETER, AN OBJECT WHICH APPEARED TO BE ¿TRASH¿ WAS FOUND INSIDE THE STERILE INNER PACKAGE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT CATHETER. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7592829 ↗
• MalfunctionMay 3, 2018Signal Artifact/Noise; Bent; Signal Artifact/Noise; Bent

  THIS EVENT IS REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED 4/6/18. IT WAS REPORTED THAT UPON ABLATION IN THE RIGHT ATRIUM, NOISE APPEARED ON THE 1-2 BIPOLAR DISPLAY. IT WAS NECESSARY TO REPLACE THE CATHETER TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS OCCURRED. IT WAS ALSO NOTED THAT THE TIP OF THE CATHETER WAS BENT OUT OF THE BOX. DEVICE ANALYSIS REVEALED A COMPROMISED SEAL ON RING 1.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7483456 ↗
• MalfunctionFeb 21, 2018Insufficient Heating; Insufficient Heating

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2018. IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO ABLATE. A INTELLATIP MIFI¿ XP TEMPERATURE ABLATION CATHETER WAS SELECTED FOR A ATRIAL FLUTTER(AFL) ABLATION. HOWEVER ABLATION WAS PERFORMED WITH 60W AND 60 DEGREES SETTINGS, BUT WHILE THE W INCREASED, THE TEMPERATURE DID NOT INCREASE MORE THAN ABOUT 40 DEGREES, AND IT DID NOT CHANGE WITHOUT REDUCING THE POTENTIAL OF THE MINI ELECTRODE OF MIFI. ABLATION WAS PERFORMED FOR ABOUT 15 TIMES, THE PROCEDURE WAS COMPLETED WITH ANOTHER INTELLATIP MIFI. NO COMPLICATIONS WERE REPORTED. HOWEVER ANALYSIS REVELED BROKEN RING SEAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7285931 ↗
• MalfunctionJan 24, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 12JAN2018. IT WAS REPORTED THAT THE CATHETER STOPPED STEERING IN ONE DIRECTION. DURING AN ABLATION PROCEDURE TO TREAT RIGHT ATRIAL FLUTTER IN THE RIGHT ATRIUM WITH AN INTELLATIP MIFI XP ABLATION CATHETER, THE CATHETER STOPPED STEERING IN ONE DIRECTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS. DEVICE ANALYSIS REVEALED THE PROXIMAL SEAL OF RING 1 AND THE SEALS OF RING 2 WERE COMPROMISED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7216566 ↗

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