OCTARAY Mapping Catheter D160901Recalls & reported problems

Summary

The FDA's MAUDE database contains 113 adverse event reports that list this exact device (DI 10846835021141), received between Aug 29, 2022 and Apr 3, 2026 — classified as 1 death, 36 injuries, 76 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (38 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 113 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH AN OCTARAY MAPPING CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A LIFTED ELECTRODE AND A PLASTIC FIBER ATTACHED TO THE ELECTRODE. INITIALLY, IT WAS REPORTED THAT AT THE END OF THE PROCEDURE, WHEN THEY PULLED OUT THE OCTARAY CATHETER, THEY NOTICED A PLASTIC STRINGLIKE PIECE ATTACHED TO THE BASE OF THE SPLINES. UNRAVELED LIKE A SWEATER UNRAVELED. THEY HAD NO ISSUES WITH THE CATHETER DURING THE PROCEDURE. NO PATIENT CONSEQUENCE REPORTED. THE CATHETER WAS BRAND NEW FROM BIOSENSE WEBSTER, INC. BOX PACKAGING. ADDITIONAL INFORMATION WAS RECEIVED. DOES NOT BELIEVE THAT THERE WERE WIRES EXPOSED. DID NOT RESULT IN ANY LIFTED OR SHARP RINGS. THE PHYSICIAN NEVER MENTIONED ANY RESISTANCE. IT WAS NOT KNOWN IF THE DEVICE WAS PRE-SHAPED. THE PLASTIC STRINGLIKE PIECE ISSUE WAS ASSESSED AS MDR REPORTABLE UNDER THE VIZIGO SHEATH REPORTED UNDER MANUFACTURER REPORT NUMBER 2029046-2026-00581. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE OCTARAY MAPPING CATHETER FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 09-MAR-2026, FOUND A LIFTED ELECTRODE IN ONE OF THE SPLINES,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24776369 ↗
• InjuryMar 25, 2026Device-Device Incompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION AND THE PATIENT EXPERIENCED HYPOTENSION AND BLEEDING THAT REQUIRED BLOOD TRANSFUSION. IT WAS REPORTED THAT THEY WERE ADVANCING THE FARAWAVE¿ PFA CATHETER BACK INTO THE BODY WHEN THE ANESTHESIOLOGIST STATED THE PATIENT BLOOD PRESSURE HAS DROPPED (50/40). THE PROCEDURE WAS STOPPED. THE PATIENT'S HEMOGLOBIN WAS CHECKED, AND IT ALSO DROPPED (3-4 POINTS). XRAY AND CONTRAST WERE USED TO LOCATE THE BLEED, THEY WERE UNSUCCESSFUL AND THE PATIENT WAS TAKEN TO A CT SCAN (COMPUTED TOMOGRAPHY). THE MEDICAL INTERVENTION WAS ADMINISTERING BLOOD; HOWEVER, IT WAS UNKNOWN IF ANY MEDICATIONS WERE GIVEN. THE PATIENT LAST KNOWN STATUS WAS STABLE AND INTUBATED. EARLIER IN THE CASE, THEY WERE UNCERTAIN AND WORRIED THAT THERE MAY HAVE BEEN A PERFORATION WHEN THEY HAD TROUBLE ADVANCING THE OCTARAY¿ CATHETER. IT KEPT GETTING STUCK, SO IT WAS REMOVED. THEY THEN ATTEMPTED TO ADVANCE THE WIRE AND THEY EXPERIENCED DIFFICULTY. THE SHEATH WAS REPLACED AND THEY WERE ABLE TO ADVANCE THE WIRE. THE PHYSICIAN WAS UNSURE ON THE CAUSE OF THE EVENT. HE THOUGHT IT MAY HAVE OCCURRED EARLY IN THE CASE WHEN HE WAS HAVING DIFFICULTY ADVANCING THE OCTARAY

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension

  MAUDE report 24691045 ↗
• MalfunctionMar 24, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER AND APPROXIMATELY 3 HOURS AFTER CATHETER INSERTION INTO THE PATIENT¿S BODY, NOTICED THAT OCTARAY IRRIGATION WAS NOT PERFORMING. THE MEDICAL TEAM ATTEMPTED TO FLUSH WITH THE SYRINGE, BUT IT WAS STIFF AND FLUSHING COULD NOT BE PERFORMED. BECAUSE THERE WAS A RISK FOR THROMBUS FORMATION, A NEW CATHETER WAS OPENED, THE NEW CATHETER FLUSHED WITHOUT ISSUE, AND THE PROCEDURE WAS CONTINUED. THE PROCEDURE WAS COMPLETED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681503 ↗
• InjuryMar 19, 2026Patient 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. AFTER PRE-MAPPING THE LEFT ATRIUM, DECREASE IN PATIENT¿S BLOOD PRESSURE WAS OBSERVED, AND PERICARDIAL EFFUSION WAS CONFIRMED WITH ECHOCARDIOGRAPHY. PERICARDIOCENTESIS WAS PERFORMED, THE PATIENT¿S VITAL BECAME STABLE, AND THE PROCEDURE WAS TERMINATED. PATIENT IMPROVED. THERE WAS A POSSIBILITY THAT IT OCCURRED AFTER BB OR DURING LEFT ATRIUM ACCESS. NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. THERE WAS NO EVIDENCE OF STEAM POP. PROCEDURAL ACTIVATED CLOTTING TIME (ACT) WAS 350 SECONDS. NO ABLATIONS WERE PERFORMED. THE PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION.

  Patient problems: Cardiac Tamponade

  MAUDE report 24639462 ↗
• MalfunctionMar 17, 2026Failure to Advance

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER AND THE INTRODUCER BECAME TRAPPED IN SHEATH HUB, REQUIRING REMOVAL OF INTRODUCER WITH FORCEPS. THERE WERE NO ISSUES WITH LOADING OR ADVANCING INTO THE DELIVERY SHEATH, NO LEAKING ISSUES, NO CHAR OR DEVICE EMBOLIZATION. NO DEFLECTION ISSUES. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24624417 ↗
• MalfunctionMar 16, 2026Contamination /Decontamination Problem; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER WHICH HAD A PIECE OF PLASTIC COME OUT WITH IT UPON REMOVAL FROM THE PATIENT. IT WAS REPORTED BY THE CUSTOMER THAT WHILE ADVANCING WITH THE OCTARAY¿ CATHETER, IT "DID NOT GO UP." THE BWI REPRESENTATIVE REPORTED THAT AFTER PULLING BACK THE OCTARAY¿ CATHETER, A PIECE OF PLASTIC CAME WITH IT AND THE SPLINE WAS ALSO BENT. THE BWI REPRESENTATIVE REPORTED THAT THE PHYSICIAN DECIDED TO CONTINUE MAPPING WITH THE QDOT MICRO¿ CATHETER. THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE. THE OCTARAY MAPPING CATHETER WAS USED WITH A SHEATH WAS PINNACLE TERUMO 8FR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24607850 ↗
• InjuryMar 9, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A VIZIGO SHEATH AND AN OCTARAY MAPPING CATHETER. WHILE ADVANCED INTO THE LEFT ATRIUM, NOTICED A BLOOD CLOT ATTACHED TO THE CATHETER SPLINE. THE REPORT INDICATED THAT AFTER THE PHYSICIAN RE-INSERTED THE OCTARAY MAPPING CATHETER INTO THE CARTO VIZIGO SHEATH, IT WAS ADVANCED INTO TO LEFT ATRIUM AND THEY NOTICED A BLOOD CLOT ATTACHED TO THE CATHETER SPLINE. IT WAS NOTICED ON THE INTRACARDIAC ECHO AND CONFIRMED ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE). NO CLOTS WERE NOTICED PRIOR TO THE PROCEDURE. THE CATHETER WAS REMOVED FROM THE BODY. THE EVENT OCCURRED TOWARDS THE END OF THE PROCEDURE AND THE POST MAPPING WAS ABORTED. THE PATIENT WAS ADMINISTERED HEPARIN. THE PATIENT¿S LAST KNOW STATUS WAS STABLE. THE INFORMATION RECEIVED INDICATED THAT THE CLOT VISUALIZED ON TIP OF THE OCTARAY MAPPING CATHETER SPLINES. THE PHYSICIAN SUSPECTS CLOT INSIDE VIZIGO SHEATH AND WHEN HE ADVANCED THE OCTARAY MAPPING CATHETER IT WAS DISLODGED. THE PATIENT DID NOT EXHIBIT NEUROLOGICAL SYMPTOMS SINCE THE PROCEDURE WAS COMPLETED. THE SYSTEM DID NOT PRESENT ANY ERROR MESSAGES, AND THE PHYSICIAN/USER SAW THE CLOT ON THE TIP OF THE

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24554431 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER AND THE PATIENT EXPERIENCED HEART BLOCK TREATED WITH TEMPORARY PACEMAKER AND PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT POST AFIB PROCEDURE, THE PATIENT WAS WAKING UP FROM ANESTHESIA AND WENT INTO HEART BLOCK. A TEMPORARY PACEMAKER WAS PLACED. THE PHYSICIAN THOUGHT IT WAS ANESTHESIA RELATED. THE PATIENT'S HEART RHYTHM RETURNED, AND THE PATIENT WAS SENT TO OBSERVATION. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT IT WAS PATIENT CONDITION/ANESTHESIA REACTION. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF STAYING OVERNIGHT TO MONITOR THEIR CONDUCTION. THE PATIENT HAD WIDE LEFT BUNDLE BRANCH BLOCK (LBBB) MORPHOLOGY BEFORE THE PROCEDURE.

  Patient problems: Heart Block; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24549957 ↗
• MalfunctionFeb 26, 2026Contamination /Decontamination Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A OCTARAY MAPPING CATHETER AND A "HAIR-LIKE" MATERIAL ON ONE OF THE SPLINES. IT WAS REPORTED THAT AFTER OPENING THE PRODUCT PACKAGING AND PLACING THE OCTARAY MAPPING CATHETER IN THE STERILE FIELD, IT WAS NOTICED THAT THERE WAS A TWO OR THREE INCH LONG "HAIR-LIKE" MATERIAL; WITH MOVEMENT, ON ONE OF THE SPLINES OF THE OCTARAY MAPPING CATHETER. THE OCTARAY MAPPING CATHETER WAS REPLACED AND THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE. THE DEVICE WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24465972 ↗
• MalfunctionFeb 18, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A OCTARAY MAPPING CATHETER AND THERE WAS SOME RESISTANCE IN THE RIGHT ATRIUM AND THE SPLINES WERE "BUNCHED UP TOGETHER". THE PHYSICIAN NOTED RESISTANCE NOT WITHIN THE SHEATH BUT WITHIN THE ATRIUM ITSELF. AN INSERTION TOOL HAD BEEN USED. WHEN THE MEDICAL TEAM REMOVED THE CATHETER FROM THE BODY, THERE WAS SOME CARDIAC TISSUE ON ONE OF THE SPLINES. THE MEDICAL TEAM WAS GOING TO BIOPSY THE TISSUE DUE TO UNRELATED PATIENT ISSUES. NO INJURY TO THE PATIENT. THE CATHETER HAD NOT BEEN INSPECTED FOR LIFTED OR SHARPENED RINGS. THE TEAM CONTINUED USING THE SAME CATHETER AFTER THE TISSUE WAS REMOVED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24379578 ↗
• MalfunctionFeb 17, 2026Manufacturing, Packaging or Shipping Problem; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER AND WHEN THE STERILE PACKAGING WAS OPENED, ONE OF THE SPINES WAS CONFIRMED TO BE BENT. THE CATHETER WAS REPLACED WITH A NEW ONE. THE REPLACEMENT CATHETER HAD NO SHAPE PROBLEMS. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. THIS EVENT WAS ORIGINALLY ASSESSED AS NOT MDR REPORTABLE. THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION OF THE RETURNED DEVICE WAS PERFORMED. VISUAL ANALYSIS REVEALED THAT ONE OF THE SPLINES OF THE DEVICE WAS BENT, WITHOUT EXPOSED WIRES; ADDITIONALLY, SOME ELECTRODES OF THIS FAILURE SPLINE WERE DAMAGED. THIS FINDING IS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24372626 ↗
• MalfunctionFeb 12, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER AND SALINE SOLUTION DID NOT FLOW FROM THE CATHETER TIP. THE REPORT INDICATED THAT JUST BEFORE INSERTING THE CATHETER INTO THE PATIENT'S BODY FOR PULMONARY VEIN ISOLATION (PVI) POST-MAP, WHEN ATTEMPTING TO START IRRIGATION, SALINE SOLUTION DID NOT FLOW FROM THE CATHETER TIP. DURING PRE-MAPPING, IRRIGATION WAS FUNCTIONING NORMALLY. IT OCCURRED APPROXIMATELY 2 HOURS AFTER THE START OF THE PROCEDURE, BEFORE POST-MAP. SINCE SALINE SOLUTION COULD NOT FLOW WITH STRONG PRESSURE, EVEN WHEN TRYING TO INJECT DIRECTLY WITH A SYRINGE WITHOUT USING THE TUBE, THE CATHETER WAS REPLACED, WHICH IMPROVED THE ISSUE. THE PROCEDURE WAS THEN COMPLETED WITHOUT ANY PROBLEMS. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. ADDITIONAL INFORMATION INDICATED THAT THE SUSPECTED DEVICE IS THE CATHETER. NO PUMP WAS USED. THE PRESSURE BAG WAS USED FOR THE OCTARAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24320003 ↗
• MalfunctionFeb 5, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL TACHYCARDIA (AT) ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER AND THE CATHETER WAS NOT IRRIGATING PROPERLY DURING USE ON THE PATIENT. IT WAS REPORTED THAT THE PHYSICIAN WAS CONCERNED THAT THE CATHETER WAS NOT IRRIGATING PROPERLY. THE CALLER STATED THAT THE PHYSICIAN COMPLAINED THAT THE CATHETER IRRIGATION SEEMED SLOWER THAN NORMAL. THE CALLER STATED THAT BECAUSE THEY STOPPED SEEING THE ARRYTHMIA, THE PROCEDURE WAS COMPLETED WITHOUT ABLATION AND THE CATHETER WAS NOT REPLACED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24274858 ↗
• MalfunctionDec 30, 2025Entrapment of Device; Off-Label Use; Entrapment of Device; Off-Label Use

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH OCTARAY MAPPING CATHETER. DURING MAPPING, THE OCTARAY MAPPING CATHETER SPLINE BECAME CAUGHT ON A MECHANICAL VALVE. TIMING WAS DURING POST MAPPING. THE OCTARAY MAPPING CATHETER WAS REMOVED USING A SNARE. PROGRESS WAS REPORTED AS THE SPLINE WAS REMOVED INTACT WITHOUT FRACTURING; THEREFORE, THERE WAS NO IMPACT ONTO THE PATIENT. NO PROLONGATION OF HOSPITALIZATION. THE PHYSICIAN WAS AWARE THAT USE ON A MECHANICAL VALVE IS CONTRAINDICATED AND HAD BEEN MANIPULATING THE CATHETER CAUTIOUSLY, BUT IT NONETHELESS BECAME CAUGHT. THERE WERE NO ABNORMALITIES OBSERVED PRIOR NOR DURING USE OF THE PRODUCT. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THE OCTARAY MAPPING CATHETER WAS REMOVED INTACT WITHOUT DETACHING THE SPLINES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23924151 ↗
• MalfunctionDec 29, 2025Coagulation in Device or Device Ingredient; Obstruction of Flow; Coagulation in Device or Device Ingredient; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ¿ PAROXYSMAL ABLATION PROCEDURE AND THE IRRIGATION ON THE OCTARAY¿ CATHETER WAS NOT CONNECTED TO THE CATHETER TOWARDS THE END OF THE PROCEDURE. IT IS UNKNOWN WHEN THE IRRIGATION WAS REMOVED FROM THE CATHETER. THEY CHECKED THE CATHETER, AND THERE WAS SOME CLOTTING. WHEN THE CATHETER WAS REPLACED, THE PROBLEM WAS RESOLVED AND THE CASE CONTINUED. THERE WAS NO ADVERSE PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THE SUSPECTED ISSUE IS WITH EITHER THE OCTARAY¿ CATHETER OR THE OCTARAY¿ IRRIGATION TUBING AS IT WAS SUSPECTED THE TUBING BECAME DISCONNECTED AT SOME POINT. THE DEVICE WAS USED IN THE PATIENT. NGEN¿ PUMP WAS IN USE FOR ABLATION. NO ERROR WAS ON THE IRRIGATION PUMP AS THE ISSUE WAS ON THE OCTARAY¿ TUBING THAT IT WAS NOT CONNECTED. TO RESOLVE THIS ISSUE, THEY REMOVED THE OCTARAY¿ AND REPLACED IT. CORRECT SETTINGS WERE ON THE NGEN¿ GENERATOR AND THERE WERE NO ISSUES WITH THE FLOW RATE AT THE START OF ABLATION. WHEN THE OCTARAY¿ CATHETER WAS REMOVED, THERE WERE VISIBLE CLOTS ON THE ELECTRODES. THE SYSTEM PRESENTED NO ERRORS, AND THE PHYSICIAN NOTICED THE IRRIGATION TO THE OCTARAY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23919310 ↗
• MalfunctionDec 4, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A OCTARAY MAPPING CATHETER AND THE IRRIGATION LUMEN WAS OCCLUDED AND IRRIGATION DID NOT FLOW. (THE IRRIGATION WAS FOUND TO BE FLOWING AT THE START OF USE.) AFTER ABLATING THE POSTERIOR WALL, WHEN OCTARAY WAS REMOVED BEFORE CTI (CAVOTRICUSPID ISTHMAS) ABLATION. THE OCCLUSION ALARM SOUNDED TWICE. FOR THE FIRST ALARM, THE THREE-WAY STOPCOCK WAS OPENED, PERFORMED A FLUSH TO CONFIRM PATENCY, AND THEN RESTARTED IRRIGATION. AFTER A SHORT TIME THE ALARM SOUNDED A SECOND TIME, SO THE CATHETER WAS REMOVED FROM THE PATIENT¿S BODY AND THE OCCLUSION WAS CONFIRMED. SINCE THE ISSUE WAS RELATED TO OCTARAY, IT WAS NOT RELATED TO THE GENERATOR. THE IRRIGATION ISSUE WAS NOTED AFTER THE DEVICE HAD ALREADY BEEN USED ON THE PATIENT. AFTER THE OCCLUSION WAS CONFIRMED, THE PROCEDURE WAS COMPLETED WITHOUT USING OCTARAY--THE CATHETER WAS REPLACED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23723082 ↗
• MalfunctionNov 4, 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 IT WAS NOT IRRIGATING PROPERLY. IT WAS REPORTED THAT WHEN THE CATHETER ABOUT TO BE REINSERTED INTO THE BODY, THE PHYSICIAN NOTICED THAT THE CATHETER WAS NOT IRRIGATING PROPERLY. CALLER STATED THEY OPENED THE PRESSURE LINE WITHOUT RESOLUTION. THEY TRIED MANUALLY FLUSHING THE CATHETER WITHOUT RESOLUTION. WHEN THE CATHETER WAS REPLACED, THE ISSUE RESOLVED. THE CATHETER WAS BRAND NEW AND NOT REPROCESSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23472244 ↗
• MalfunctionOct 28, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A OCTARAY MAPPING CATHETER AND AFTER THE PROCEDURE'S COMPLETION THE CATHETER WAS REMOVED FROM THE COMPETITOR COMPANY'S SHEATH AND A FINE THREAD WAS OBSERVED COMING OUT FROM THE SPINE. BECAUSE THE THREAD WAS ENTANGLED WITH THE SPINE, IT WAS UNCLEAR WHETHER THE THREAD CAME FROM THE OCTARAY OR FROM ANOTHER MATERIAL, SUCH AS INNER MATERIAL PEELED OFF FROM THE SHEATH. THE PHYSICIAN DID NOT EXPERIENCE ANY RESISTANCE WHEN INTRODUCING OR RETRACTING THE CATHETER. THERE WERE NO DAMAGES NOTED ON THE OCTARAY EITHER. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23410305 ↗
• MalfunctionOct 28, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER AND OBSERVED AN IRRIGATION ISSUE (USED IN PATIENT). THE INFUSION PUMP FOR THE OCTARAY MAPPING CATHETER, IRRIGATION FREQUENTLY TRIGGERED AN OCCLUSION ALARM. ATTEMPTED TO PRESSURE INFUSION DIRECTLY FROM THE SYRINGE THROUGH THE IRRIGATION TUBE WERE MADE, BUT RESISTANCE WAS ENCOUNTERED, AND IRRIGATION COULD NOT BE PERFORMED SUCCESSFULLY. THE TIMING WAS IMMEDIATELY AFTER INSERTING THE OCTARAY MAPPING CATHETER AT THE FIRST TIME. RESOLVED BY REPLACING THE OCTARAY MAPPING CATHETER WITH ANOTHER NEW ONE. 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. THE OCCLUSION ALARM WAS NOTED SEVERAL TIMES. SINCE THE ISSUE WAS RELATED TO THE OCTARAY MAPPING CATHETER, IT WAS NOT RELATED TO THE GENERATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23410134 ↗
• MalfunctionSep 5, 2025Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER AND DURING THE OPERATION, WHILE THE CATHETER WAS INSIDE THE PATIENT¿S BODY, THERE WAS ELECTROCARDIOGRAM (ECG) SIGNAL INTERFERENCE. THE SIGNAL INTERFERENCE (NOISE) WAS OBSERVED ON THE INTRACARDIAC ECG CHANNEL, WHICH WAS OBSERVED ON THE CARTO® ONLY. THE PHYSICIAN HAD AN INTACT ECG SIGNAL AVAILABLE TO MONITOR THE PATIENT¿S HEART RHYTHM. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. THIS EVENT WAS ORIGINALLY ASSESSED AS NOT MDR REPORTABLE. THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION AND ELECTRICAL TEST OF THE RETURNED DEVICE WERE PERFORMED. VISUAL INSPECTION REVEALED THAT THE SHAFT WAS BROKEN IN THE MID-SECTION WITH EXPOSED WIRES. THIS FINDING IS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22983625 ↗
• MalfunctionAug 21, 2025Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL TACHYCARDIA (AT) CARDIAC ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED THREE ELECTRODES THAT WERE LIFTED ON THE B SPLINES. INITIALLY, IT WAS REPORTED THAT THERE WAS NOISE ON THE B SPLINES OF THE CATHETER THAT WERE SEEN ON CARTO 3 SYSTEM AND THE RECORDING SYSTEM. THEY RESEATED THE CATHETER, BUT THE ISSUE PERSISTED. THEY REPLACED THE CABLE WITH NO RESOLUTION. WHEN THEY REPLACED THE CATHETER, THE ISSUE WAS RESOLVED. THERE WAS NO PATIENT CONSEQUENCE. THE SIGNAL NOISE ISSUE WAS ASSESSED AS NON MDR REPORTABLE. THE RISK OF PATIENT HARM IS CONSIDERED REMOTE. THE BIOSENSE WEBSTER, INC. PAL RECEIVED THE DEVICE AND PER THE EVALUATION COMPLETION, THREE ELECTRODES WERE FOUND LIFTED ON THE B SPLINES. THIS WAS ASSESSED AS MDR REPORTABLE WITH AN AWARENESS DATE OF 25-JUL-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22869412 ↗
• MalfunctionAug 17, 2025Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  DURING THE POST-MAP AFTER PULSED FIELD ABLATION (PFA), THE PULSESELECT AND THE SPINES OF OCTARAY MICRO BECAME TANGLED. SINCE THE TANGLING DID NOT RESOLVE, THE PULSESELECT WAS PULLED AND THE OCTARAY¿S SPINE WAS PULLED INTO THE PS SHEATH TO DETACH THE OCTARAY¿S SPINE. THE OCTARAY¿S SPINE WAS DETACHED WHILE IN THE CARDIAC CAVITY. THEN BOTH CATHETERS WERE REMOVED. THE DETACHED SPINE WAS ATTACHED TO THE PS, SO IT WOULD NOT BE REMAINED INSIDE THE CARDIAC CAVITY. THE DETACHMENT WAS DESCRIBED AS A TOTAL DETACHMENT; SPINE WAS SEPARATED. THERE WAS NO RESISTANCE WAS FELT DURING INSERTION. THERE WAS RESISTANCE DURING REMOVAL BECAUSE IT GOT TANGLED WITH PULSESELECT. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22824516 ↗
• InjuryAug 4, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING CARDIAC ABLATION WITH AN OCTARAY MAPPING CATHETER, THE PATIENT EXPERIENCED A CARDIAC TAMPONADE TREATED WITH PERICARDIOCENTESIS AND REQUIRED PROLONGED HOSPITALIZATION. DURING PRE-MAPPING WITH THE OCTARAY MAPPING CATHETER, THE PATIENT'S BLOOD PRESSURE DECREASED. EFFUSION WAS CONFIRMED BY ECHOCARDIOGRAPHY, AND PERICARDIOCENTESIS WAS PERFORMED, BUT THE BLEEDING COULD NOT BE STOPPED, AND THE BLOOD PRESSURE REMAINED UNSTABLE, LEADING TO TRANSFER OF THE PATIENT TO ANOTHER FACILITY. THE TIMING OF THE PERFORATION REMAINS UNCLEAR. POSSIBLE OCCURRENCES INCLUDE DURING INSERTION INTO THE CORONARY SINUS (CS) OR DURING THE BROCKENBROUGH. SINCE THE CS-OSTIUM WAS WIDE AND INSERTION WAS EASY, THE PERFORATION LIKELY OCCURRED DURING BROCKENBROUGH USE. THE PHYSICIAN'S OPINIONS ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT WERE NO COMMENT. IT WAS PREDICTED TO BE A PERFORATION DURING BROCKENBROUGH. PROLONGATION OF HOSPITAL STAY WAS NOTED. NO ABNORMALITIES OBSERVED PRIOR/DURING USE OF THE PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED ON 10-JUL-2025. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT IT WAS PROCEDURE RELATED. THE PHYSICIAN SUSPECTED THAT

  Patient problems: Cardiac Tamponade

  MAUDE report 22703208 ↗
• InjuryAug 1, 2025Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Patient Device Interaction Problem; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER (LEFT) ABLATION WITH A OCTARAY MAPPING CATHETER AND THE PATIENT EXPERIENCED DEVICE SEPARATION THAT RESULTED IN FOREIGN BODY. IT WAS REPORTED THAT ONE OF THE OCTARAY SPLINES WERE STRIPPED OF INSULATION WHEN MAPPING NEAR THE MITRAL VALVE (MECHANICAL). THE PATIENT WAS STABLE AT THE TIME OF THE CALL WITH NO INJURY REPORTED AT THIS TIME. THE DAMAGE DID RESULT IN WIRES BEING EXPOSED BUT DID NOT LEAD TO ANY SHARP RINGS. NO RESISTANCE TO INSERTION OR REMOVAL OF DEVICE. A VIZIGO SHEATH WAS USED. THE DETACHMENT WAS PARTIAL, THE DETACHED PORTION WAS LODGED IN A SMALL INTERCOSTAL ARTERY CAUSING NO HARM AND THEY WERE LEAVING IT IN PLACE. PATIENT FULLY RECOVERED. IT WAS REPORTED THAT PART OF THE OCTARAY IS STILL INSIDE THE PATIENT AND THE MEDICAL TEAM DID NOT REMOVE THE SPLINE THAT WAS IN THE ARTERY,

  Patient problems: Foreign Body In Patient

  MAUDE report 22692753 ↗
• MalfunctionJul 28, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER AND SOME KIND OF ADHERING SUBSTANCE WAS FOUND. DURING RIGHT ATRIUM (RA) MAPPING, OCTARAY DID NOT RISE TO THE SUPERIOR VENA CAVA (SVC). WHEN OCTARAY WAS TAKEN OUT OF THE PATIENT ¿S BODY TO SWITCH TO A WIRE GUIDE, SOME KIND OF ADHERING SUBSTANCE WAS FOUND ON THE SPINE OF THE OCTARAY. COLOR AND SHAPE OF THE ADHERING SUBSTANCE: IT WOUND AROUND THE SPINE AT ABOUT ONE-THIRD OF THE HEIGHT FROM THE BASE OF OCTARAY2-2-2. THE SIZE WAS APPROXIMATELY 1 CM WHEN SPREAD OUT, AND IT WAS WHITE, RESEMBLING A CHIARI NET-LIKE MESH. PHYSICIAN'S OPINION: A CHIARI NET WAS SUSPECTED, BUT IT COULD NOT BE CONFIRMED THROUGH INTRACARDIAC ECHO OR BODY SURFACE ECHO, SO IT IS UNCLEAR WHAT THE SUBSTANCE IS. THERE WERE NO ISSUES WITH THE VITAL SIGNS DURING THE PROCEDURE. BOTH DURING THE PROCEDURE AND THE BODY SURFACE ECHOCARDIOGRAPHY BEFORE THE PATIENT LEFT THE ROOM, THERE WERE NO ABNORMALITIES. BEFORE RA MAPPING, THE INTRACARDIAC ECHO WITH SOUNDSTAR WAS PERFORMED BUT THE CHIARI NETWORK COULD NOT BE CONFIRMED. DESPITE CONFIRMING VALVE MOTION DURING THE BODY SURFACE ECHOCARDIOGRAPHY DURING THE PROCEDURE, AND BEFOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22638414 ↗