OCTARAY Mapping Catheter D160906Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 10846835021134), received between Sep 1, 2022 and Sep 23, 2026 — classified as 2 deaths, 19 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (20 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, 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 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Obstruction of Flow

  It was reported that a patient underwent an Atrial Fibrillation (AFib) ablation procedure with an OCTARAY Mapping Catheter which was unable to be flushed after ablation. It was reported that there was an irrigation issue involving the OCTARAY catheter. The caller reported that after delivering Pulsed Field Ablation (PFA) with the FARAWAVE PFA CATHETER, they were unable to successfully flush the OCTARAY catheter. They replaced the OCTARAY catheter and the issue was resolved. The procedure continued. There was no patient consequence.Additional information received indicated the suspected device with the issue is the catheter, not the BD Alaris Pump. The catheter was hooked up to a pressure drip, which was working properly, but nothing would flush through the catheter, even trying with a syringe. The device was irrigated properly initially, therefore used on the patient, but it did not irrigate after switching from PFA back to mapping with Octaray Mapping Catheter. There was no error on the pump. The catheter was flushed outside the body before inserting back into the body and it was discovered that it could no longer flush. To troubleshoot, we confirmed that there was flow through th

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867250 ↗
• InjuryAug 11, 2026Failure to Sense; Patient Device Interaction Problem

  It was reported that a patient underwent an atrial fibrillation ablation procedure with a OCTARAY Mapping Catheter and the patient experienced a cardiac tamponade which required pericardiocentesis. While mapping the left atrium, the catheter went into the right atrium without them noticing it. When the catheter went into the coronary sinus (CS), the medical team realized the catheter was no longer in the left atrium. When they tried to go back into the left atrium, they got a lot of resistance from the catheter. At that point, they noticed the Carto 3 System displayed a Magnetic Distortion error on the OCTARAY catheter. Then the patient¿s blood pressure went from stable blood pressure to 43 over 37. The intracardiac echocardiogram (ICE) catheter was pulled from the left atrium into the right atrium and that is when they noticed a large pericardial effusion, so they removed the OCTARAY catheter and the 13 French Agilis sheath from the body. The pericardial effusion was confirmed by ICE (intracardiac echocardiography). Medical intervention provided was pericardiocentesis and 5880cc of fluid was removed before the patient was taken to cardiothoracic (CT) surgery. CT surgeon confirmed

  Patient problems: Cardiac Perforation

  MAUDE report 50216862 ↗
• MalfunctionMar 26, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE FOR PREMATURE VENTRICULAR CONTRACTIONS (PVCS) AND THE IRRIGATION OF THE OCTARAY MAPPING CATHETER APPEARED COMPLETELY BLOCKED. VISUALLY, THERE WAS NO IRRIGATION OUTLET. THEY FORCE PURGED OUTSIDE OF THE BODY WITH SODIUM CHLORIDE (NACL) SYRINGE. USING A PRESSURIZED SYRINGE DID NOT RESTORE THE SALINE FLOW. A NEW CATHETER WAS USED FOR THE SECOND PART OF THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AFTER A DELAY OF TEN MINUTES. THE DEVICE WAS USED IN THE PATIENT. THE ISSUE WAS IDENTIFIED DURING THE SECOND PART OF MAPPING, ON THE SECOND INTRODUCTION OF THE CATHETER. THERE WERE NO ISSUES WITH THE FLOW RATE CHANGE AT THE START OF ABLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24695473 ↗
• MalfunctionMar 13, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH AN OCTARAY MAPPING CATHETER AND OBSERVED THE CATHETER DID NOT FLUSH (DEVICE WAS USED IN THE PATIENT). THE OCTARAY¿ CATHETER DID NOT FLUSH WITH PRESSURE LINE. THE CATHETER WAS REPLACED AND THE ISSUE RESOLVED. THE CALLER NOTED THAT IT WAS A BRAND NEW CATHETER. THE PROCEDURE CONTINUED WITH NO FURTHER ISSUES. UNABLE TO CONFIRM THE GENERATOR USED. NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 18-FEB-2026. THE SUSPECTED DEVICE FOR THE REPORTED FLOW/IRRIGATION ISSUE WAS THE CATHETER BASED UPON THE INFORMATION REPORTED. THE DEVICE WAS USED IN THE PATIENT. STEPS TAKEN TO RESOLVE THE IRRIGATION ISSUE WAS REPLACED THE CATHETER AND THEN COMPLETED THE PROCEDURE. THE CATHETER ¿DID NOT FLUSH¿ ISSUE WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE ON 18-FEB-2026 THAT THE DEVICE WAS USED IN THE PATIENT AND HAVE REASSESSED THE EVENT AS REPORTABLE. THE AWARENESS DATE FOR THIS RECORD IS 18-FEB-2026 BECAUSE THE CATHETER DID NOT FLUSH (DEVICE WAS USED IN THE PATIENT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24595760 ↗
• MalfunctionJan 22, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A OCTARAY MAPPING CATHETER AND A PIECE OF SPLINE STRIPED OFF. IT WAS REPORTED THAT DURING THE PROCEDURE BOTH THE OCTARAY AND FARAWAVE¿ NAV PFA CATHETER WERE IN THE LEFT ATRIUM AND WHEN THE PHYSICIAN WAS PULLING THE FARAWAVE¿ NAV PFA CATHETER THROUGH THE SHEATH THE CATHETER SNAGGED ONE OF THE OCTARAY SPLINES AND IT STRIPED OFF. THE CALLER STATED THE PATIENT IS OKAY AND THERE WAS NO PATIENT INJURY. THE PIECE THAT CAME OFF, CAME OUT OF THE BODY INSTANTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24157734 ↗
• DeathJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING CARDIAC ABLATION PROCEDURE WHICH INCLUDED THE USE OF AN OCTARAY MAPPING CATHETER, THE PATIENT EXPERIENCED TAMPONADE THAT REQUIRED DRAINAGE. THE PATIENT DIED. CARDIAC TAMPONADE OCCURRED DURING THE PROCEDURE. THE OCTARAY WAS THE ONLY DEVICE USED DURING THE CASE; HOWEVER, THE PHYSICIAN THOUGHT THAT IT WAS DUE TO THE TRANSSEPTAL. "QUICK MINUTES" AFTER THE MAPPING STARTED, THE BLOOD PRESSURE HAD FALLEN AND THEY DID AN ECHOCARDIOGRAPHY AND THEY SAW A MAJOR TAMPONADE. HE DIRECTLY STOPPED THE MAPPING AND TREATED THE TAMPONADE. THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT WAS THE PUNCTURE OF THE TRANSSEPTAL AND THAT THERE WAS NO IMPLICATION WITH BIOSENSE WEBSTER (BWI) PRODUCTS. THE PUNCTURE WAS DONE WITH THE ETO AND BRK 71CM. HOWEVER, THE EVENT WAS DISCOVERED AT THE START OF MAPPING. NO ABLATION CATHETER WAS USED. THERE WAS NO ERROR MESSAGE OBSERVED ON BWI EQUIPMENT DURING THE PROCEDURE. INTERVENTION WAS PROVIDED WHICH INCLUDED THE PHYSICIAN DRAINED THE PATIENT; HOWEVER, THE PATIENT PASSED AWAY.

  Patient problems: Cardiac Tamponade

  MAUDE report 22613179 ↗
• MalfunctionJul 17, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A OCTARAY MAPPING CATHETER AND DURING THE REMAP PHASE OF THE PROCEDURE, AND (AFTER SUCCESSFULLY PERFORMING A FIRST MAP, THE DEVICE COULD NOT BE FLUSHED AT ALL WITH THE HEPARINIZED NACL SOLUTION. THERE WERE NO ERRORS NOTED PRIOR TO DISCOVERING THE ISSUE. ALSO, AS FLUSHING WAS BEING MADE, IRRIGATION WOULD NOT GO THROUGH CATHETER. ALL TROUBLESHOOTING WAS DONE, BUT THE BWI IRRIGATION TUBE WAS SWITCHED FOR A NEW ONE WITH NO SUCCESS. IRRIGATION WAS DONE THROUGH THE PUMP TO CHECK IF THE PUMP WAS FUNCTIONING, WHICH IT WAS. THE ISSUE WAS ONLY SOLVED BY REPLACING WITH A NEW OCTARAY CATHETER. THERE WERE NO CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22534501 ↗
• InjuryJul 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING IDVT (IDIOPATHIC VENTRICULAR TACHYCARDIA) CARDIAC ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER, THE PATIENT EXPERIENCED COMPLETE HEART BLOCK TREATED DURING THE PROCEDURE WITH CATHETER PACING, THEN PLACEMENT OF A PERMANENT PACEMAKER IMPLANT. WHEN CROSSING THE TRICUSPID VALVE WITH THE OCTARAY CATHETER, THE CATHETER BUMPED INTO THE CONDUCTION SYSTEM. THIS RESULTED IN COMPLETE HEART BLOCK, NOTED ON THE 12 LEAD ECG (ELECTROCARDIOGRAM) SIGNALS. THE PATIENT WAS PACED WITH AN RV (RIGHT VENTRICULAR) QUAD CATHETER FOR THE REST OF THE PROCEDURE, AND CONDUCTION DID NOT RECOVER. THIS HEART BLOCK OCCURRED BEFORE ANY ABLATION HAD BEEN PERFORMED. THE PATIENT HAD A PERMANENT PACEMAKER IMPLANT POST ABLATION TO TREAT THE HEART BLOCK. THE PATIENT IS CURRENTLY STABLE. OCTARAY CATHETER IS UNAVAILABLE FOR RETURN. A STERILMED CS CATHETER, NGEN GENERATOR, AND CARTO 3 SYSTEM WERE USED IN THIS PROCEDURE. THE INFORMATION RECEIVED INDICATED THAT THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT THE BLOCK WAS CAUSED BY BRUSHING PAST THE AREA WITH THE OCTARAY, AND DID NOT FEEL THAT ANY EQUIPMENT MALFUNCTIONED OR PERFORMED NOT AS INTENDED.

  Patient problems: Heart Block

  MAUDE report 22524311 ↗
• MalfunctionJun 3, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A OCTARAY MAPPING CATHETER AND IT WAS NOT FLUSHING. IT WAS REPORTED THAT THERE WAS DIFFICULTY FLUSHING THE OCTARAY MAPPING CATHETER PRIOR TO REINSERTING THE CATHETER FOR THE THIRD TIME. THE PHYSICIAN POWER FLUSHED THE CATHETER SUCCESSFULLY, BUT WHEN BACK ON THE PRESSURE LINE THE CATHETER WAS NOT FLUSHING AGAIN. THEY EXCHANGED THE OCTARAY MAPPING CATHETER TO CONTINUE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22131296 ↗
• MalfunctionMay 22, 2025Signal Artifact/Noise; Material Twisted/Bent; Signal Artifact/Noise; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REDO ATRIAL FIBRILLATION / REDO ATRIAL FLUTTER - LEFT-SIDED PROCEDURE WITH AN OCTARAY MAPPING CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A LIFTED ELECTRODE. IT WAS REPORTED THAT THERE WAS NOISE ON THE D SPLINE OF THE CATHETER DISPLAYED ON THE CARTO 3 SYSTEM AND THE RECORDING SYSTEM. THE PHYSICIAN NOTICED A KINKED SPLINE ON THE CATHETER BEFORE ADVANCING THE CATHETER INTO THE BODY. THE CATHETER CONNECTIONS WERE RESEATED FROM BOTH ENDS WITHOUT RESOLUTION. THE CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED WITH NO FURTHER ISSUES. THE NGEN SYSTEM WAS USED FOR ABLATION. NO PATIENT CONSEQUENCE REPORTED. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 30-APR-2025, OBSERVED BENT MARKS IN ONE SPLINE. A MICROSCOPIC INSPECTION SHOWED A LIFTED ELECTRODE WITHOUT WIRES EXPOSED. THE EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF A LIFTED ELECTRODE ON 30-APR-2025 AND HAVE ASSESSED THIS RETURNED CONDITION AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22075031 ↗
• MalfunctionMay 16, 2025Tear, Rip or Hole in Device Packaging; Packaging Problem; Tear, Rip or Hole in Device Packaging; Packaging Problem

  IT WAS REPORTED THAT THE DELIVERED OCTARAY MAPPING CATHETER STERILE PACKAGING WAS RECEIVED OPENED. THE CATHETER WAS REPORTED DELIVERED AND RECEIVED WITH DAMAGE ON THE OUTSIDE OF THE BOX AND SMALL DAMAGE ON THE INSIDE BOX. THE CATHETER STERILE PACKAGING WAS ALSO OPENED. NO PATIENT INVOLVEMENT WAS REPORTED. THE DAMAGE ON THE OUTSIDE OF THE BOX AND SMALL DAMAGE ON THE INSIDE BOX WAS ASSESSED AS NON MDR REPORTABLE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, WAS REMOTE. THE STERILE PACKAGING RECEIVED OPENED WAS ASSESSED AS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22038619 ↗
• InjuryMay 14, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH AN OCTARAY MAPPING CATHETER, AND THE PATIENT EXPERIENCED ACUTE RESPIRATORY DISTRESS THAT REQUIRED INTUBATION AND HYPOTENSION THAT REQUIRED MEDICATION. IT WAS REPORTED THAT DURING A PFA ATRIAL FIBRILLATION CASE (ALTHOUGH NO PFA APPLICATION WAS ADMINISTERED TO THE PATIENT), MUCUS WAS NOTICED IN THE PATIENT'S LEFT LUNG. AFTER THEY HAD GONE TRANSSEPTAL WITH A BAYLIS ENERGY NEEDLE AND SL1 SHEATH AND BEGAN MAPPING IN THE LEFT ATRIUM WITH THE OCTARAY MAPPING CATHETER, IT WAS NOTICED THAT THERE WAS A DECREASE OR DECOMPENSATION IN THE PATIENT'S BLOOD PRESSURE. THE PATIENT'S BLOOD PRESSURE WAS READING AROUND THE 50'S OVER 30'S, BUT THE CALLER COULD NOT CONFIRM THIS INFORMATION. CARDIOTHORACIC (CT) SURGERY WAS CONSULTED, AND A CT SCAN WAS ORDERED FOR THE PATIENT. IT WAS CONFIRMED VIA CT SCAN THAT NO PERFORATION WAS PRESENT IN THE PATIENT, BUT THERE WAS MUCUS CONFIRMED TO BE IN THE PATIENT'S LEFT LUNG. BLOOD PRESSURE MEDICATION WAS ADMINISTERED TO THE PATIENT; HOWEVER, NO DETAILS REGARDING THE MEDICATION OR THE DOSAGE WERE PROVIDED. THE PATIENT WAS THEN INTUBATED AND TRANSFERRED TO THE MEDICAL INTENSIVE CARE UNIT (IC

  Patient problems: Low Blood Pressure/ Hypotension; Respiratory Failure

  MAUDE report 22021722 ↗
• MalfunctionApr 25, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PERSISTENT ATRIAL FIBRILLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER. BAD IRRIGATION DURING THE PROCEDURE. THE IRRIGATION WAS NO LONGER EFFECTIVE AT THE ¿TOO¿ OF THE CATHETER (WAS GOOD AT THE BEGINNING OF THE PROCEDURE). CHANGED THE CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PROCEDURE WAS DELAYED 5 MINUTES. NO PATIENT CONSEQUENCE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21909936 ↗
• MalfunctionApr 2, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER AND AN IRRIGATION ISSUE OCCURRED DURING USE ON THE PATIENT. IT WAS REPORTED THAT WHEN THE OCTARAY WAS FLUSHED TO BE USED AGAIN AFTER THE REMAP, THE CATHETER WAS OCCLUDED. THE CATHETER WAS REPLACED AND THE CASE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21753791 ↗
• MalfunctionMar 31, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH OCTARAY MAPPING CATHETER. UPON INITIALLY OPENING THE PRODUCT PACKAGE FOR THE OCTARAY MAPPING CATHETER, IT WAS NOTICED THAT THE PACKAGING WAS NOT STERILE. THE "TOP PLASTIC PORTION" OF THE PRODUCT PACKAGE WAS MISSING, SO THE OCTARAY MAPPING CATHETER WAS NOT STERILE. THE OCTARAY¿ CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21735484 ↗
• MalfunctionMar 25, 2025Detachment of Device or Device Component; Device-Device Incompatibility; Material Deformation; Detachment of Device or Device Component; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER AND THE CATHETER WAS PHYSICALLY DAMAGED. THE OCTARAY WAS IN THE RIGHT ATRIUM THROUGH THE SHEATH. THE DOCTOR FELT AN UNUSUAL RESISTANCE WHEN PULLING IT OUT. HE THEN NOTICED THAT ONE OF THE SPLINES WAS DAMAGED AND THAT THE DISTAL ELECTRODE FROM THAT SPLINE WAS GONE. HE PASSED A GUIDE WIRED IN THE SHEATH AND PULLED IT OUT OF THE PATIENT TO CHECK IT AND FLUSHED IT WITHOUT ANY ABNORMAL FEELING. AFTER THAT, HE PUT THE DILATOR IN THE SHEATH (OUTSIDE THE PATIENT) TO ACCESS LEFT ATRIUM AGAIN BUT FELT RESISTANCE. ONCE THE DILATOR WAS SEEN OUTSIDE THE SHEATH TIP, SOME KIND OF WIRING FROM THE DAMAGED OCTARAY SPLINE WAS PUSHED OUT. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21692437 ↗
• MalfunctionMar 25, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER AND THE PHYSICIAN NOTED THAT THE TIP OF THE OCTARAY CATHETER WAS FRAYED AND RIPPED. WHEN THE CATHETER WAS REPLACED, THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THERE WAS RESISTANCE WHEN INSERTING INTO THE VIZIGO. THERE WERE NO WIRES BEING EXPOSED AND NO LIFTED OR SHARP RINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21684951 ↗
• MalfunctionMar 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION - PAROXYSMAL ABLATION PROCEDURE WITH A OCTARAY MAPPING CATHETER AND WHEN THE OCTARAY CATHETER WAS REMOVED FROM THE PATIENT ONE OF THE SPLINES HAD A STRING COMING OUT, IN PLACE OF THE DISTAL ELECTRODE. IT WAS UNKNOWN WHERE THE DISTAL ELECTRODE WAS--ONLY THE STRING WAS PRESENT. THE PHYSICIAN STATED THAT THE DEVICE WAS USED IN THE RIGHT ATRIUM ONLY, AND WHEN IT WAS REMOVED FOR TRANSSEPTAL ACCESS THE ISSUE WAS NOTICED AT THIS POINT IN THE PROCEDURE. THE CATHETER WAS REPLACED. THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21530006 ↗
• MalfunctionFeb 23, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER. WHEN PERFORMING A POST-MAP WITH THE OCTARAY MAPPING CATHETER, IT WAS NOTICED THAT THERE WAS "NO DRIP" COMING OUT OF THE OCTARAY MAPPING CATHETER FOR IRRIGATION. THE PHYSICIAN ATTEMPTED TO MANUALLY FLUSH THE OCTARAY MAPPING CATHETER, BUT NO FLUID WAS ABLE TO PUSH THROUGH. THE OCTARAY MAPPING CATHETER STILL WAS NOT IRRIGATING AT ALL. THE OCTARAY MAPPING CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21442750 ↗
• MalfunctionFeb 13, 2025Break; Failure to Sense; Break; Failure to Sense

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A OCTARAY MAPPING CATHETER AND THERE WAS A SENSOR ERROR, AND WHEN THE CATHETER WAS EXAMINED IT APPEARED THERE WERE WIRES EXPOSED ON ONE OF THE SPLINES. NO SHARP RINGS WERE NOTED. THE ISSUE WAS FOUND IN THE MIDDLE OF THE SPLINE. THE DEVICE WAS NOT PRE-SHAPED. THE CATHETER DID NOT GO INTO THE PATIENT. THE CATHETER WAS REPLACED AND THE CASE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21379000 ↗
• MalfunctionJan 31, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH AN OCTARAY MAPPING CATHETER. THERE WAS A "FIBER" ON ONE OF THE ELECTRODES. IT WAS ELECTRODE 4 ON AN UNKNOWN SPLINE. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS CONTINUED. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE ISSUE WAS NOTICED BEFORE USE. DEVICE WAS NOT USED IN THE PATIENT. IT WAS CLEAR AND ABOUT 1 CM LONG IN LENGTH. ONE END WAS EMBEDDED INTO THE DEVICE AND THE OTHER END WAS FREE FLOATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21284861 ↗
• MalfunctionJan 6, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER AND WHILE SETTING UP FOR THE PROCEDURE, IT WAS NOTICED THAT THE OCTARAY¿ CATHETER PACKAGING WAS MISSING THE HARD PLASTIC STERILE PACKAGING (THE HARD BLUE PLASTIC STERILE PACKAGE THAT THE OCTARAY CATHETER ITSELF IS TAKEN OUT OF IN THE STERILE FIELD). THE STERILITY OF THE OCTARAY¿ CATHETER WAS COMPROMISED. THERE WAS NO POUCH SEAL PRESENT AT ALL. THE OCTARAY¿ CATHETER WAS REPLACED AND THE PROCEDURE CONTINUED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21088156 ↗
• InjuryNov 22, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH A DECANAV CATHETER AND AN OCTARAY MAPPING CATHETER. THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION THAT REQUIRED A PERICARDIOCENTESIS. A PERICARDIAL EFFUSION WAS NOTICED WITH THE PATIENT DURING THE PROCEDURE. THE PERICARDIAL EFFUSION WAS DISCOVERED WHILE THEY WERE MAPPING THE LEFT ATRIUM. THE PHYSICIAN BELIEVES THE PERICARDIAL EFFUSION OCCURRED WHEN THEY WERE GOING TRANSEPTAL. THEY NOTICED THE PATIENT¿S BLOOD PRESSURE DROPPING AND CONFIRMED IT WITH INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AND DISCOVERED THE PERICARDIAL EFFUSION. A PERICARDIOCENTESIS PROCEDURE WAS THEN PERFORMED ON THE PATIENT. THE PATIENT¿S LAST KNOWN STATUS WAS STABLE. THEY HAD THE GENERATOR READY TO GO BUT NEVER STARTED ABLATION. A DECANAV CATHETER, AN OCTARAY CATHETER AND A STERILMED SOUNDSTAR WERE USED DURING THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED. THE PHYSICIAN BELIEVES THE CAUSE OF THE ADVERSE EVENT WAS THE TRANSSEPTAL PUNCTURE. HE SAID THE PATIENT HAD AN UNUSUALLY SMALL HEART. ONE TRANSSEPTAL PUNCTURE. TO GO TRANSSEPTAL, THE PHYSICIAN USED THE VERSACROSS STEERABLE ACCESS SHEATH BY BAYLIS. THE PHYSICIAN PERFORMED A PERICARDIO

  Patient problems: Cardiac Tamponade

  MAUDE report 20755663 ↗
• InjuryNov 21, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA ABLATION, AND THE PATIENT EXPERIENCED HEART BLOCK /ASYSTOLE THAT REQUIRED PACING AND MEDICATION. THEY WERE MAPPING WITH THE OCTARAY CATHETER IN THE AORTA/AORTIC CUSP AND WHEN THEY PULLED THE OCTARAY ACROSS THE AORTIC CUSP, THE PATIENT WENT INTO ASYSTOLE. THE HEART BLOCK CAUSED THEM TO PERFORM AN ECHO AND NO ISSUES WERE FOUND. THEY PACED FOR A FEW MINUTES UNTIL THE PATIENT WENT BACK INTO SINUS RHYTHM. THEY ALSO ADMINISTERED ISUPREL. THE PHYSICIAN THOUGHT IT WAS DUE TO THE MECHANICAL PRESSURE OR FORCE OF THE SHAFT OF THE OCTARAY ON THE AV NODE.

  Patient problems: Asystole; Heart Block

  MAUDE report 20742731 ↗
• InjuryOct 30, 2024Display or Visual Feedback Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NON ISCHEMIC VENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A OCTARAY MAPPING CATHETER AND THE PATIENT EXPERIENCED VENTRICULAR TACHYCARDIA THAT REQUIRED DEFIBRILLATION. IT WAS REPORTED THAT THE OCTARAY CATHETER SPLINES WERE NOT VISUALIZED ON THE CARTO 3 SYSTEM SCREEN. WHEN THE PHYSICIAN HAD STARTED TO MAKE VOLTAGE MAPS, THE OCTARAY CATHETER VISUALIZATION SLOWLY IMPROVED, BUT THEN THE CARTO 3 SYSTEM DISPLAYED A "CHEST PATCH MINOR MAGNETIC DISTORTION" ERROR. WHEN PLACING THE OCTARAY CATHETER HIGHER UP IN THE LEFT VENTRICLE, THE SPLINES WERE VISUALIZED NORMALLY, BUT WHEN MOVING MORE TOWARDS THE APEX, THE OCTARAY CATHETER SPLINES WOULD DISAPPEAR AGAIN, AND THEY WERE UNABLE TO TAKE ANY POINTS. THE PATIENT WAS INDUCED, AND THE OCTARAY CATHETER SPLINES WERE STILL NOT VISUALIZED. THERE WAS SUFFICIENT MATRIX AT THIS POINT. THE PATIENT "BECAME HEMODYNAMICALLY UNSTABLE" AND THE PATIENT WENT INTO VENTRICULAR FIBRILLATION (VF). THE PATIENT WAS THEN DEFIBRILLATED, AND THE PATIENT'S RHYTHM BECAME STABLE, AND HAD RESTORED. AFTER THE PATIENT HAD BEEN DEFIBRILLATED AND THE OCTARAY CATHETER WAS RE-POSITIONED IN THE HEART, THE OCTARAY CATHETER SPLINE VISUALI

  Patient problems: Ventricular Fibrillation

  MAUDE report 20564589 ↗