OCTARAY Mapping Catheter D160903Recalls & reported problems

Summary

The FDA's MAUDE database contains 146 adverse event reports that list this exact device (DI 10846835021127), received between Oct 11, 2022 and Sep 23, 2026 — classified as 36 injuries, 110 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (44 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 146 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Patient Device Interaction Problem

  It was reported that a patient underwent a paroxysmal atrial fibrillation ablation with an OCTARAY Mapping Catheter and the patient experienced a pericardial effusion that required Heparin reversed and a pericardiocentesis was performed.Slightly after the transseptal was performed, the patient had a drop in blood pressure and a pericardial effusion was confirmed with Intracardiac Echocardiography (ICE). The medical intervention performed was that Heparin was reversed and a pericardiocentesis was performed. The procedure was aborted. The last known patient status was stable.The physician believed that the pericardial occurred during the transseptal process. The OCTARAY Mapping Catheter had been advanced into the body shortly after transseptal access and that a Left Atrial pre-map was had been performed using the OCTARAY Mapping Catheter. No ablation had been performed. The Smart Touch SF DE catheter was not advanced into the body or used for ablation. The Carto 3 System was used for mapping.Multiple attempts have been made to obtain clarification of this complaint. However, no further information has been made available.

  Patient problems: Cardiac Tamponade

  MAUDE report 50869000 ↗
• MalfunctionApr 9, 2026Obstruction of Flow

  IT WAS REPORTED A PATIENT UNDERWENT AN OCTARAY MAPPING CATHETER AND AN IRRIGATION FAILURE OCCURRED. ABOUT 2 HOURS AFTER THE START OF THE PROCEDURE, WHEN REPLACING THE THERMOCOOL® SMART TOUCH® SF CATHETER (STSF) WITH THE OCTARAY MAPPING CATHETER, THE IRRIGATION WAS NOT FUNCTIONING. THE ISSUE WAS RESOLVED BY REPLACING THE CATHETER. THE PROCEDURE WAS CONTINUED AND COMPLETED WITHOUT PATIENT'S CONSEQUENCE. ADDITIONAL INFORMATION RECEIVED INDICATED IT WAS THE CATHETER THAT WAS BELIEVED TO HAVE THE IRRIGATION ISSUE AND NOT RELATED TO THE GENERATOR. THE ISSUE WAS DETECTED BY VISUAL OBSERVATION AND THE PUMP¿S ERROR ALARM SOUND. THE OCTARAY MAPPING CATHETER WAS REPLACED AND NOT REINSERTED INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24837571 ↗
• MalfunctionApr 9, 2026

  NO SIGNALS SEE ON MULTIPLE SPLINES CATHETER REPLACED WITH RESOLUTION OFTHE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24829847 ↗
• MalfunctionMar 18, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER. AN ERROR OCCURRED IN THE PERFUSION PUMP WHEN ATTEMPTING TO PERFORM POST MAPPING. THE ERROR INDICATED THAT PERFUSION WAS NOT FUNCTIONING PROPERLY, AND THE DRIP RATE FROM THE CATHETER WAS LESS THAN DURING PRE-MAPPING. THEREFORE, THE CATHETER WAS REPLACED AT THE DOCTOR'S DISCRETION. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION INDICATED THAT THE SUSPECTED DEVICE FOR THE REPORTED FLOW/IRRIGATION ISSUE IS THE CATHETER. A HOSPITAL-OWNED INFUSION PUMP WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24630844 ↗
• InjuryMar 11, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH AN OCTARAY MAPPING CATHETER AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS AND SURGICAL INTERVENTION. DURING AN ATRIAL FIBRILLATION CASE A PERICARDIAL EFFUSION WAS DIAGNOSED "AND CONFIRMED" VIA INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE PATIENT'S BLOOD PRESSURE DROPPED. A PERICARDIOCENTESIS WAS PERFORMED BY THE PHYSICIAN. THE PATIENT WAS STABLE AT THE TIME OF THE CALL AND WAS TRANSFERRED TO THE OPERATING ROOM TO "REPAIR THE LEAK". THE BOSTON FARAPULSE PFA ABLATION GENERATOR WAS THE ONLY GENERATOR USED DURING THE CASE. THE FOLLOWING J&J MEDTECH ELECTROPHYSIOLOGY PRODUCTS WERE USED DURING THE CASE: CARTO 3 REFERENCE PATCHES - LOT 027860, REFERENCE NUMBER: (B)(4) OCTARAY MAPPING CATHETER- LOT NUMBER: 31820626L, REFERENCE NUMBER: (B)(4).

  Patient problems: Cardiac Tamponade

  MAUDE report 24570382 ↗
• InjuryMar 6, 2026Patient Device Interaction Problem

  DURING A CARDIAC ABLATION PROCEDURE, WHILE USING A VIZIGO SHEATH/OCTARAY CATHETER, THE PATIENT EXPERIENCED DECREASED IN BLOOD PRESSURE AND PERICARDIAL EFFUSION/CARDIAC TAMPONADE. THE REPORT INDICATED THAT SHORTLY AFTER THE PROCEDURE STARTED, AFTER CS (CORONARY SINUS) CATHETER INSERTION, THE BLOOD PRESSURE DECREASED AND PERICARDIAL EFFUSION/CARDIAC TAMPONADE WAS CONFIRMED BY EXTERNAL ECHOCARDIOGRAPHY. THE PROCEDURE WAS INTERRUPTED. PERICARDIAL DRAINAGE WAS PERFORMED, AND THE BLOOD PRESSURE STABILIZED. THE PATIENT LEFT THE ROOM AFTER HEMOSTASIS WAS CONFIRMED. THE EVENT WAS NOT RESOLVED AND THE PROCEDURE WAS INTERRUPTED. THE SEPTAL PUNCTURE NEEDLE WAS RF (RADIOFREQUENCY) NEEDLE. THE PHYSICIAN¿S ASSESSMENT ON THE HEALTH HAZARD WAS NOT-SERIOUS (MODERATE/MILD). THE PHYSICIAN¿S COMMENT ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT WAS THAT THE EVENT OCCURRED BEFORE PRODUCT USE, SO THERE WAS NO CAUSAL RELATIONSHIP. NO EXTENSION OF HOSPITALIZATION WAS NOTED. THE VISITAG COLORING SETTING WAS TAG INDEX, AND THE VISITAG ADDITIONAL FILTER USED WAS FOT (FORCE OVER TIME). NO ABNORMALITIES WERE OBSERVED PRIOR/DURING PRODUCT USE. CARTO 3 SYSTEM AND NGEN DEVICE WERE USED FOR THE PROCEDURE. T

  Patient problems: Cardiac Tamponade

  MAUDE report 24536353 ↗
• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. SOON AFTER BODY SURFACE DC (DIRECT CURRENT), FOLLOWING RA (RIGHT ATRIUM) MAPPING , AND IMMEDIATELY AFTER PERFORMING BB (BROCKENBROUGH), BLOOD PRESSURE DECREASE WAS OBSERVED. ECHOCARDIOGRAPHY REVEALED PERICARDIAL EFFUSION, AND PERICARDIAL DRAINAGE WAS PERFORMED. PATIENT LEFT THE ROOM. NO EXTENDED HOSPITALIZATION WAS REQUIRED. IT WAS REPORTED THAT THE PHYSICIAN'S OPINIONS ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT WAS THAT DURING BODY SURFACE DC AFTER BB, SINCE NEITHER THE OCTARAY NOR THE ABLATION CATHETER WAS IN PLACE, IT IS POSSIBLE THAT THE SHEATH MAY HAVE PERFORATED. THERE WAS NO EVIDENCE OF STEAM POP. NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. THE ADVERSE EVENT OCCURRED DURING TRANSSEPTAL PHASE. THE FORCE SENDING ABLATION CATHETER WAS A QDOT MICRO CATHETER. ADDITIONAL FILTER USED WITH THE VISITAG WAS IMPEDANCE DROP. THE COLOR OPTION THAT WAS USED PROSPECTIVELY WAS TAG INDEX. THERE WAS NO ISSUE WITH FLOW RATE CHANGE AT THE START OF ABLATION. OPEN CHEST S

  Patient problems: Cardiac Tamponade; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24405628 ↗
• MalfunctionFeb 10, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER AND SALINE SOLUTION DID NOT FLOW FROM THE IRRIGATION PORT. AT THE TIME OF CATHETER REPLACEMENT, 3 HOURS AFTER CATHETER USE, THE SALINE SOLUTION DID NOT FLOW FROM THE IRRIGATION PORT. THE IRRIGATION PRESSURE WAS INCREASED, BUT THE ISSUE WAS NOT RESOLVED. MANUAL FLUSHING WITH A SYRINGE COULD NOT BE PERFORMED, SO THE ISSUE WAS RESOLVED BY REPLACING THE CATHETER. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24309167 ↗
• InjuryFeb 6, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH A OCTARAY MAPPING CATHETER AND THE PATIENT EXPERIENCED A CARDIAC PERFORATION THAT REQUIRED PERICARDIOCENTESIS AND SURGICAL INTERVENTION. IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION CASE, A PERICARDIAL EFFUSION WAS NOTICED IN THE PATIENT. THE MEDICAL TEAM HAD OBTAINED TRANSSEPTAL ACCESS FOR THE BAYLIS SHEATH AND THE OCTARAY¿ CATHETER, AND COMPLETED A PRE-VOLTAGE MAP FOR THE LEFT ATRIUM. TOWARDS THE END OF THE PRE-VOLTAGE MAPPING, THE OCTARAY¿ CATHETER THEN "FELL OUT" OF THE LEFT ATRIUM. THE PHYSICIAN WAS ABLE TO RE-INSERT THE BAYLIS SHEATH AND THE OCTARAY¿ CATHETER BACK INTO THE LEFT ATRIUM AND PROCEED. WHEN THE PHYSICIAN WAS IN THE PROCESS OF EXCHANGING THE BAYLIS SHEATH FOR A FARADRIVE¿ SHEATH, A PERICARDIAL EFFUSION WAS NOTICED ON ICE (INTRACARDIAC ECHOCARDIOGRAPHY). ECHO WAS BROUGHT IN LATER ON, AND THE PERICARDIAL EFFUSION WAS ALSO CONFIRMED VIA ECHO. THE MEDICAL INTERVENTION PROVIDED TO THE PATIENT WAS A PERICARDIOCENTESIS, AND ABOUT 1300ML OF FLUID WAS REMOVED. THE PHYSICIAN BELIEVES THAT WHEN EXCHANGING THE BAYLIS SHEATH FOR A FARADRIVE¿ SHEATH, THAT THEY MAY HAVE GONE THROUGH A PFO (PATENT

  Patient problems: Cardiac Perforation

  MAUDE report 24284409 ↗
• MalfunctionJan 27, 2026Obstruction of Flow; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH AN OCTARAY CATHETER AND A FLUID LEAK OCCURRED. IT WAS REPORTED THAT THE OCTARAY CATHETER WAS ADVANCED INTO THE BODY WHEN THEY NOTICED IT WAS NOT IRRIGATING (THE LIQUID WAS LEAKING BACK OUT). THE CALLER NOTED THE CATHETER WAS REMOVED FROM THE BODY AND THE PHYSICIAN STATED THE PLASTIC CONNECTOR TUBE FOR THE IRRIGATION WAS BROKEN. THE CATHETER WAS REPLACED AND THE ISSUE RESOLVED. THE PROCEDURE CONTINUED WITH NO FURTHER ISSUES. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24196128 ↗
• MalfunctionJan 20, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER, AND AN IRRIGATION ISSUE WAS OBSERVED. THEY CONFIRMED THERE WAS AN ISSUE WITH IRRIGATION. AT THE START OF THE PROCEDURE, THERE WAS NOTHING WRONG WITH IRRIGATION; HOWEVER, THEY TRIED POST VOLTAGE MAPPING AND CHECKED THE IRRIGATION AND FOUND THAT THERE WAS SOMETHING WRONG. THEY CHANGED THE CATHETER. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24122419 ↗
• InjuryJan 16, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, WHILE POST ABLATION MAPPING WITH A OCTARAY MAPPING CATHETER, THE PATIENT EXPERIENCED VT (VENTRICULAR TACHYCARDIA) TREATED WITH DEFIBRILLATION. RIGHT CORONARY ARTERY (RCA) ANGIOGRAM SHOWED OCCLUSION THAT REPERFUSE OVERTIME AND IT WAS JUDGED TO BE A SPASM. ADDITIONALLY, THE ECG (ELECTROCARDIOGRAPHY) SHOWED ST ELEVATION THAT IMPROVED AFTER REPERFUSION. THE OUTCOME OF THE ADVERSE EVENT WAS FULLY RECOVERED (NO RESIDUAL EFFECTS). NO EXTENDED HOSPITALIZATION WAS NOTED. THE REPORT INDICATED THAT AFTER ABLATION WAS CONDUCTED IN CTI (CAVOTRICUSPID ISTHMUS) USING FARAPULSE (BOSTON SCIENTIFIC¿S), VT OCCURRED DURING POST MAPPING WITH OCTARAY CATHETER. AFTER DEFIBRILLATION, THE VT STOPPED. RIGHT CORONARY ARTERY (RCA) ANGIOGRAPHY WAS PERFORMED, AND IT WAS FOUND THAT THE CORONARY ARTERY WAS OCCLUDED. SINCE THE REPERFUSION OCCURRED OVER TIME, THE PHYSICIAN JUDGED IT TO BE A SPASM. ALTHOUGH THE ECG SHOWED ST ELEVATION, THE EVENT IMPROVED AFTER REPERFUSION. ON LATER REVIEW, ST HAD ELEVATED AFTER ABLATION. DURING THE PROCEDURE, CORONARY REPERFUSION OCCURRED. THE ECG SHOWED THAT THE HEART RHYTHM HAD RETURNED TO THE SAME PATTERN WHEN THE PATIENT

  Patient problems: Cardiac Arrest; Tachycardia; Vasospasm

  MAUDE report 24102813 ↗
• InjuryJan 14, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT) PROCEDURE WITH AN OCTARAY MAPPING CATHETER AND SUFFERED A PERICARDIAL EFFUSION AND A VESSEL PERFORATION WHICH REQUIRED A PERICARDIOCENTESIS, SURGICAL INTERVENTION AND PROLONGED HOSPITALIZATION. THE REPORT INDICATED DURING THE PROCEDURE, A PERICARDIAL EFFUSION WAS NOTICED. AFTER CARDIOVERTING THE PATIENT, THE PHYSICIAN DISCOVERED A PERICARDIAL EFFUSION. THE PERICARDIAL EFFUSION WAS CONFIRMED BY INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE MEDICAL INTERVENTION PROVIDED WAS PERICARDIOCENTESIS, BUT THEY NOTICED THAT THE PERICARDIAL EFFUSION KEPT GROWING. THEY CONTINUED TO TAP THE PATIENT BEFORE DECIDING TO SEND THEM TO SURGERY WHEN THEY DID NOT CONTINUE TO IMPROVE. THE PATIENT WAS CURRENTLY IN THE OPERATING ROOM (OR) BUT WAS REPORTED TO BE IN STABLE CONDITION. THE HOLE HAD BEEN FOUND IN THE INFERIOR VENA CAVA (IVC). THE PHYSICIAN BELIEVED THAT THE CORONARY SINUS (CS) CATHETER MAY HAVE BEEN TOO FAR OUT WHEN THEY CARDIOVERTED THE PATIENT WHICH WOULD HAVE CAUSED THE INJURY BUT SINCE THE HOLE WAS FOUND DURING SURGERY IN THE IVC THEY ARE NO LONGER CERTAIN WHAT MAY HAVE CAUSED THE PERICARDIAL EFFUSION. THE PHYSICIAN DO

  Patient problems: Cardiac Tamponade; Perforation of Vessels

  MAUDE report 24076455 ↗
• MalfunctionDec 15, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A OCTARAY MAPPING CATHETER AND 3-HOURS AFTER BEING INSERTED INTO THE CARDIAC CAVITY, IRRIGATION COULD NOT BE PERFORMED. NO ERROR MESSAGES OR FLOW RATE CHANGE ISSUES PRECEDED THIS ISSUE. THE MEDICAL TEAM REPLACED THE CATHETER WITH ANOTHER NEW ONE, AND THE PROCEDURE WAS CONTINUED. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23804945 ↗
• MalfunctionDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL PROCEDURE WITH A VIZIGO SHEATH AND AN OCTARAY MAPPING CATHETER AND A SMALL WIRE ¿LIKE A FISHING TINY WIRE¿ ISSUE WAS OBSERVED. AFTER MAPPING WITH THE OCTARAY MAPPING CATHETER FOR CREATION OF THE MAP, THERE WAS A SMALL WIRE ¿LIKE A FISHING TINY WIRE¿ ATTACHED TO A SPLINE AND WAS GETTING OUT WHILE THE PHYSICIAN WAS WITHDRAWING THE CATHETER FROM THE VIZIGO SHEATH. THEY CHANGED THE OCTARAY MAPPING CATHETER AND WAS NOT INTRODUCED AFTER INTO THE PATIENT. THE PHYSICIAN PUT THE SMALL WIRE ASIDE; HOWEVER, IT WAS LOST. THEREFORE, UNABLE TO PUT THE WIRE IN THE BAG WITH THE OCTARAY MAPPING CATHETER. THE WIRE WAS ABOUT 1-2 FEET TALL. NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED ON 24-SEP-2025. NO PICTURE TAKEN. IT WAS ATTACHED TO ONE OF THE OCTARAY MAPPING CATHETER¿S SPLINE¿S. PHYSICAL DAMAGE NOT NOTICEABLE WITH EYES BUT THE SMALL WIRE THEY WERE ABLE TO SEE IT LIKE A FISHING WIRE. WIRES EXPOSED FROM THE CATHETER. THEY DID NOT SEE ANY LIFTED OR SHARP RINGS FROM THE CATHETER. NO DIFFICULTY AT ALL EXPERIENCED WHILE MANEUVERING THE CATHETER OR DURING WITHDRAWAL. IT WAS FROM THE FIRST 5 MINUTES RIGHT WHEN THEY SWITCHED FROM THE OCT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23804726 ↗
• InjuryDec 5, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER LEFT (L-AFL) PROCEDURE WITH AN OCTARAY MAPPING CATHETER AND SUFFERED A CARDIAC PERFORATION WHICH REQUIRED A PERICARDIOCENTESIS, CARDIOTHORACIC (CT) SURGERY AND PROLONGED HOSPITALIZATION. INITIALLY, IT WAS REPORTED THAT A "20 POLE A DEFECTIVE CABLE" ERROR (CODE UNKNOWN BY THE CALLER) APPEARED ON THE CARTO 3 SYSTEM. THE CABLE WAS REPLACED WITH NO RESOLUTION. THE FIRST OCTARAY MAPPING CATHETER WAS REPLACED WITH THE SECOND OCTARAY MAPPING CATHETER AND THE ISSUE RESOLVED. THE CASE CONTINUED. THE CATHETER WAS BRAND NEW FROM BIOSENSE WEBSTER, INC. BOX PACKAGING. THEN, IT WAS ALSO REPORTED THAT DURING THE ATRIAL FLUTTER PROCEDURE A PERICARDIAL EFFUSION WAS DISCOVERED DUE TO A DROP IN BLOOD PRESSURE. THE EFFUSION WAS ALSO NOTICED ON THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) IMAGE FROM THE SOUNDSTAR CATHETER. THE EFFUSION WAS CONFIRMED WHEN THEY SAW THE EFFUSION ON THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) IMAGE, THE PATIENT'S BLOOD PRESSURE, THE PATIENT'S HEART RATE ALL "GET WORSE". PERICARDIOCENTESIS WAS PERFORMED BY THE PHYSICIAN. CARDIOTHORACIC (CT) SURGERY WAS REQUIRED AND PERFORMED ON THE PATIENT. THE PATIENT WAS NOW STABLE. THE EF

  Patient problems: Cardiac Perforation

  MAUDE report 23725094 ↗
• MalfunctionNov 18, 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 THE CATHETER STOPPED IRRIGATING PROPERLY. IT WAS REPORTED THAT THE OCTARAY MAPPING CATHETER STOPPED IRRIGATING PROPERLY AFTER IT WAS REMOVED FROM THE BODY. WHEN THEY ATTEMPTED TO FLUSH THE CATHETER, THEY NOTICED IT WAS DRIPPING VERY LITTLE FLUID. WHEN THE CATHETER WAS REPLACED, THE ISSUE RESOLVED. REPLACEMENT CATHETER REQUESTED. THE CATHETER WAS BRAND NEW AND NOT REPROCESSED. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THE ISSUE WAS NOT NOTED BEFORE THE DEVICE WAS USED ON PATIENT. THE CATHETER WAS CONNECTED TO A FLUSH LINE AND WAS NOT CONNECTED TO A PUMP. THE PHYSICIAN NOTED THAT IT WAS NOT FLUSHING PROPERLY, AND NO ERROR WAS NOTED FROM THE IRRIGATION PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23583751 ↗
• MalfunctionNov 13, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER. AND AN IRRIGATION ISSUE (DEVICE USED IN PATIENT) WAS OBSERVED. NO ERROR CODE WAS DISPLAYED. REFLUX WAS NOT FLOWING PROPERLY FROM THE PRESSURE BAG. IT IS SUSPECTED THAT THE INSIDE OF THE OCTARAY MAPPING CATHETER MAY HAVE BEEN DAMAGED. SINCE IT WAS NEAR THE END OF THE PROCEDURE, THE PROCEDURE WAS DECIDED TO FINISH AS IT WAS. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED. THE SUSPECTED DEVICE FOR THE REPORTED FLOW/IRRIGATION ISSUE WAS THE CATHETER. THE DEVICE WAS USED IN THE PATIENT. NO PUMP WAS USED. NO ERROR. ADEQUATE IRRIGATION WAS NOT OBSERVED DURING PRESSURE BAG¿ASSISTED CATHETER IRRIGATION. NO STEPS TAKEN TO RESOLVE THE IRRIGATION ISSUE SINCE IT WAS NEAR THE END OF THE PROCEDURE, THE PROCEDURE WAS DECIDED TO FINISH AS IT WAS. SINCE THE ISSUE WAS RELATED TO OCTARAY MAPPING CATHETER, IT WAS NOT RELATED TO THE GENERATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23550537 ↗
• MalfunctionOct 24, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH AN OCTARAY MAPPING CATHETER AND A PIECE OF MATERIAL WAS WRAPPED AROUND THE BASE SPLINES OF THE OCTARAY MAPPING CATHETER WHEN IT WAS PULLED OUT OF THE AGILIS SHEATH. IT LOOKED LIKE A PIECE OF BLUE CLOTH LINT. NO OTHER MATERIAL WAS FOUND ALONG THE CATHETER. NO ISSUES WERE REPORTED DURING THE PROCEDURE. NO VISIBLE DAMAGE WAS REPORTED TO THE CATHETER. THEY WILL RETURN THE CATHETER AND THE MATERIAL FOR ANALYSIS. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION OF THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23382902 ↗
• MalfunctionOct 16, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A OCTARAY MAPPING CATHETER AND AFTER 3 HOURS OF USE, POOR IRRIGATION WAS CONFIRMED. A FLUSH WAS ATTEMPTED OUTSIDE THE PATIENT¿S BODY, BUT POOR IRRIGATION REMAINED UNRESOLVED. THE ISSUE WAS RESOLVED BY REPLACING THE OCTARAY TO ANOTHER ONE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23319262 ↗
• InjuryOct 16, 2025Coagulation in Device or Device Ingredient; Patient Device Interaction Problem; Coagulation in Device or Device Ingredient; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH AN OCTARAY MAPPING CATHETER AND THE PATIENT EXPERIENCED A BLOOD CLOT REMOVED ALONG WITH THE OCTARAY MAPPING CATHETER. DURING A CARTO 3 MAPPED PROCEDURE WITH BOSTON SCIENTIFIC PFA AND BEFORE GOING TRANSSEPTAL WITH A FARADRIVE SHEATH (13 INNER DIAMETER), A BLOOD CLOT WAS PULLED FROM THE PATIENT. THE LEFT SIDED MAPPING WITH AN OCTARAY MAPPING CATHETER (8.5 FRENCH) AFTER THEY GAINED ACCESS, ANESTHESIA GAVE 15000 HEPARIN, AND THEY CHECKED THE ACT AND IT WAS READ AT 118. THE ANESTHESIA GAVE 5000 MORE HEPARIN AND READ ACT WAS AT 112. THEY WERE DONE MAPPING, THE PHYSICIAN PULLED THE OCTARAY MAPPING CATHETER AND REALIZED THAT A "GIANT LONG CLOT" CAME OUT WITH IT. THE PHYSICIAN PUT A WIRE IN TO SEE WHY THIS WAS HAPPENING AND REALIZED THE IV THEY WERE USING TO GIVE DRUGS TO INTUBATE WAS INFILTRATED AND HEPARIN WAS NOT GOING IN. THEY IMMEDIATELY SWITCHED IVS AND PUSHED ANOTHER 15000 HEPARIN, AND THIS GOT THE ACT UP TO 415. WHILE WAITING FOR THE HEPARIN TO CIRCULATE TO READ THE NEW ACT, THE DOCTOR DECIDED TO ABORT THE PROCEDURE JUST IN CASE THE PATIENT WAS HAVING A CEREBRAL EVENT. THE PATIENT WOKE UP THEY WERE

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23317785 ↗
• MalfunctionSep 5, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER AND REFLOW OBSTRUCTION OCCURRED DURING USE. IT OCCURRED TWO HOURS AFTER USE, DURING POST MAPPING. THE ISSUE WAS RESOLVED BY REPLACING THE OCTARAY WITH A NEW ONE. THE PROCEDURE WAS COMPLETED WITHOUT ADVERSE PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THE CATHETER WAS THE SUSPECTED DEVICE FOR THE FLOW/IRRIGATION ISSUE. THE DEVICE WAS USED IN THE PATIENT. SYRINGE PUMP ERROR OCCURRED. NO ERROR OCCURRED WITH THE CARTO SYSTEM. SALINE WAS NOT VISUALLY CONFIRMED TO HAVE IRRIGATED FROM THE CATHETER TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22975677 ↗
• MalfunctionAug 8, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH AN OCTARAY MICRO AND WOULD NOT FLUSH POST MAPPING. IT WAS REPORTED BY THE BWI REPRESENTATIVE THAT THE BRAND NEW OCTARAY MICRO WOULD NOT FLUSH DURING THE PROCEDURE. THE CALLER STATED THE ISSUE OCCURRED WHILE THEY TRIED TO POST MAP. THE CALLER STATED THERE WERE NO ERRORS FROM THE PUMP AND PHYSICIAN NOTED NO FLOW COMING THROUGH CATHETER WHEN TRYING TO FLUSH. THERE WAS NO VISIBLE DAMAGE TO THE CATHETER. THE CATHETER WAS REPLACED AND THE ISSUE RESOLVED. THE PROCEDURE WAS CONTINUED. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE SUSPECTED DEVICE WITH THE ISSUE WAS THE CATHETER. THE ISSUE WAS NOTICED BEFORE POST MAP. THERE WAS NO ERROR FROM THE NGEN PUMP. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR AND THERE WERE ISSUES WITH FLOW RATE CHANGE AT THE START OF ABLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22757354 ↗
• MalfunctionJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL TACHYCARDIA (AT) ABLATION PROCEDURE WITH A OCTARAY MAPPING CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A ELECTRODE DAMAGED. THE ELECTRODE WAS OBSERVED LIFTED AND DISPLACED FROM ITS ORIGINAL POSITION LEAVING INTERNAL COMPONENTS EXPOSED. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT THE OCTARAY WAS USED IN THE PROCEDURE IN CONJUNCTION WITH THE VIZIGO SHEATH AND THERE WERE NO PROBLEMS WITH THE OCTARAY ITSELF. AS SUCH, THE INITIAL REPORTED EVENT WITH THE OCTARAY MAPPING CATHETER WAS NOT CONSIDERED TO BE MDR REPORTABLE. ON (B)(6) 2025, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND AN ELECTRODE WAS OBSERVED LIFTED AND DISPLACED FROM ITS ORIGINAL POSITION LEAVING INTERNAL COMPONENTS EXPOSED. THESE FINDINGS WERE REVIEWED AND ASSESSED AS MDR REPORTABLE AS A MALFUNCTION SINCE THE INTEGRITY OF THE DEVICE HAS BEEN COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22683764 ↗
• InjuryJul 17, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING THE LATTER HALF OF A CARDIAC ABLATION PROCEDURE WITH AN OCTARAY CATHETER, THE PATIENT EXPERIENCED BLOOD PRESSURE DECREASE/PERICARDIAL EFFUSION TREATED WITH DRAINAGE. THE BLOOD PRESSURE DECREASED IN THE LATTER HALF OF THE PROCEDURE. PERICARDIAL EFFUSION WAS OBSERVED, AND DRAINAGE WAS PERFORMED. BLOOD PRESSURE RECOVERED WITH THE DRAINAGE AND THE PATIENT STATUS IMPROVED. NO EXTENSION OF HOSPITALIZATION WAS REQUIRED. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS PROCEDURE RELATED. THE RELEVANT TESTS/LABORATORY DATA SHOWED HEMOGLOBIN WAS RELATIVELY LOW. ACTIVATED CLOTTING TIME (ACT) WAS 300 SECONDS OVER. ONE CATHETER EXCHANGE OCCURRED DURING THE PROCEDURE. ONE TRANSSEPTAL PUNCTURE SITE WAS PERFORMED DURING THE PROCEDURE. THE DELIVERED ENERGY WAS PFA (PULSED FIELD ABLATION).

  Patient problems: Cardiac Tamponade

  MAUDE report 22528156 ↗