OCTARAY Mapping Catheter D160904Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10846835021233), received between Aug 12, 2022 and Mar 13, 2026 — classified as 18 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (18 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 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2026Coagulation in Device or Device Ingredient; Obstruction of Flow

  A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER AND THERE WAS AN IRRIGATION ISSUE AND A CLOT FOUND. AFTER PULLING OUT THE CATHETER FROM THE LEFT ATRIUM, THE PHYSICIAN NOTICED THAT THERE WAS NO SALINE FLOW AND A CLOT IN THE LUMEN DURING OPERATION. THE CLOT WAS OBSERVED IN THE RED CIRCLE IS LUMEN. HEPARINIZED NORMAL SALINE WAS USED. ACTIVATED CLOTTING TIME (ACT) >300 WAS MAINTAINED. NO ABLATION WAS DONE DURING USE OF THE OCTARAY CATHETER. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24594105 ↗
• MalfunctionFeb 4, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER, AND AFTER REMOVING THE OCTARAY¿ CATHETER FROM THE BODY, AFTER MAPPING, IT WAS NOTICED THAT THE CATHETER WAS NOT PROPERLY IRRIGATING. IT WAS CONFIRMED THAT THE IRRIGATION TUBING WAS CONNECTED PROPERLY AND FLOWING. THE OCTARAY¿ CATHETER WAS MANUALLY ASPIRATED, BUT THE ISSUE PERSISTED. THE OCTARAY¿ CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED WITH NO FURTHER ISSUES. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24255444 ↗
• InjuryDec 24, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING AN ATRIAL TACHYCARDIA ABLATION PROCEDURE, AFTER MAPPING WITH AN OCTARAY CATHETER, THE PATIENT EXPERIENCED CARDIAC PERFORATION AND PERICARDIAL EFFUSION TREATED WITH PERICARDIOCENTESIS. THE PATIENT WAS STABLE. AT 11:33 AM, THE TRANSSEPTAL WAS PERFORMED. AFTER MAPPING IN THE LEFT ATRIUM WITH THE OCTARAY CATHETER, IT WAS ABOUT TO BE EXCHANGED WITH THE QDOT MICRO CATHETER. AROUND THIS TIME (12:15 PM), THE PATIENT EXPERIENCED A DROP IN BLOOD PRESSURE AND A MODERATE EFFUSION WAS FIRST NOTICED ON INTRACARDIAC ECHO (ICE). AN INTERVENTIONAL PHYSICIAN WAS BROUGHT IN AND A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS STABLE AT THE TIME OF THE CALL; FURTHER INTERVENTION WAS UNDETERMINED. NO ABLATION WAS PERFORMED PRIOR TO THE COMPLICATION. THE PRODUCTS USED WERE QDOT MICRO CATHETER, OCTARAY CATHETER, SOUNDSTAR CATHETER, VIZIGO SHEATH, CS CATHETER, AND CARTO 3 SYSTEM.

  Patient problems: Cardiac Perforation

  MAUDE report 23886795 ↗
• MalfunctionDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INITIALLY, IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION AFIB ¿ PERSISTENT ABLATION PROCEDURE WITH A VIZIGO AND AFTER FINISHING THE PROCEDURE WITHOUT ANY INCIDENCES OR ABNORMAL EVENTS, ALL CATHETERS AND SHEATHS WERE REMOVED FROM THE PATIENT'S BODY AND IT WAS NOTICED THAT A STRANGE THREAD OF SOME KIND OF PLASTIC MATERIAL WAS WRAPPED AROUND AND HANGING FROM THE BASE OF THE SPLINES OF THE OCTARAY CATHETER. THE PHYSICIAN DID NOT EXPERIENCE ANY DIFFICULTY OR ABNORMALITIES IN THE HANDLING DURING THE CASE. THE CATHETER WAS USED IN THE LEFT ATRIUM (LA) VIA A VIZIGO SHEATH, WHICH UNFORTUNATELY WAS ALREADY DISCARDED AND NOT AVAILABLE FOR RETURN. NO PATIENT CONSEQUENCES HAVE BEEN OBSERVED SO FAR. WITH THE INITIAL INFORMATION AVAILABLE, THIS EVENT WAS ASSESSED AS MDR REPORTABLE AGAINST VIZIGO AND AN INITIAL 3500A REPORT WAS SUBMITTED TO THE FDA ON 29-OCT-2025 UNDER REPORT#: 2029046-2025-03614. HOWEVER, THE OCTARAY DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION AND FOURIER TRANSFORM INFRARED SPECTROSCOPY (FT-IR) OF THE RETURNED DEVICE WERE PERFORMED. VISUAL ANALYSIS REVEALED ELECTRODES LIFTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23844355 ↗
• MalfunctionNov 25, 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 AFTER IT WAS USED FOR A WHILE AND REMOVED FROM THE BODY. THERE WAS NO VISIBLE DAMAGE TO THE CATHETER. WHEN THE CATHETER WAS REPLACED, THE ISSUE RESOLVED. THE FAULTY CATHETER WAS BRAND NEW AND NOT REPROCESSED. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT ONLY A PRESSURIZED HEPARINIZED SALINE BAG WAS USED, NO AUTOMATIC PUMP. THERE WAS NO ERROR CODE, AND THEY ONLY OBSERVED LACK OF FLOW. TO RESOLVE THE IRRIGATION ISSUE, THEY INCREASED THE PRESSURE IN PRESSURIZED BAG, THEY NOTICED A VISUAL CONFIRMATION OF IRRIGATION FLOW FROM TUBING. THE SAME IRRIGATION BAG AND TUBING WERE USED FOR THE NEW OCTARAY AND IRRIGATION WAS NOTICEABLY BETTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23653058 ↗
• InjuryOct 31, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING ATRIAL FIBRILLATION (AFIB) ABLATION AND ISCHEMIC VENTRICULAR TACHYCARDIA MAPPING PROCEDURE WITH AN OCTARAY MAPPING CATHETER AND THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION AND CODED REQUIRING TO BE TREATED WITH CARDIOVERSIONS AND CHEST COMPRESSIONS. INITIALLY, WHILE USING EXTERNAL ENERGY DETECTION (EED) DURING A FARAPULSE PULSED FIELD ABLATION (PFA) CASE, WHEN THE LOCATION PAD TURNED BACK ON AUTOMATICALLY AFTER PFA DELIVERY, IT TOOK AN UPWARDS OF 20 SECONDS FOR THE FARAWAVE CATHETER ICON TO REAPPEAR ON THE CARTO 3 SYSTEM. THEY TURNED OFF THE EED FEATURE AND THE CATHETER VISUALIZATION WAS QUICK, ONLY A COUPLE SECONDS WHEN TURNING THE LOCATION PAD BACK ON MANUALLY AFTER PFA. THEY CONTINUED THE PROCEDURE NOT USING EED FEATURE. IT WAS ALSO REPORTED THAT AFTER THE AFIB/PFA PORTION OF THE PROCEDURE, THE PHYSICIAN WAS MAPPING WITH THE OCTARAY CATHETER IN THE LEFT VENTRICLE IN SINUS RHYTHM. DURING ATTEMPTS TO TRY AND INDUCE A CLINICAL VENTRICULAR TACHYCARDIA (VT) THEY PACED WITH THE CS CATHETER (NON-JJMTEP). THE PATIENT WENT INTO VENTRICULAR FIBRILLATION (VF), NOTICED ON THE ELECTROPHYSIOLOGY (EP) RECORDING SYSTEM EKG. MULTIPLE CARDIOVERSIONS WERE UNSUCCESSFUL. A CODE WAS CALLE

  Patient problems: Cardiac Arrest

  MAUDE report 23439132 ↗
• InjuryAug 14, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER, THE PATIENT EXPERIENCED PERICARDIAL EFFUSION TREATED WITH PERICARDIOCENTESIS, DRAIN PLACEMENT, CELL SAVER AND SURGERY. BEFORE ANY ABLATION, THEY HAD GONE TRANSSEPTAL AND POST TRANSSEPTAL THEY WERE WORKING ON MANIPULATING TO PLACE CORONARY SINUS (CS) AND THEY HAD A LARGE PERICARDIAL EFFUSION. THIS WAS DISCOVERED WITH THE SOUNDSTAR CRYSTAL CATHETER AND CONFIRMED WITH THE ULTRASOUND MACHINE. A BLOOD TRANSFUSION, PERICARDIOCENTESIS, AND EMERGENT OPEN-HEART SURGERY WAS PERFORMED ON THE PATIENT. THE LAST KNOWN STATUS OF THE PATIENT WAS ALIVE AND CURRENTLY UNDER SURGERY. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT THE VERSACROSS SHEATH WAS DEEP SEATED IN THE LEFT ATRIAL APPENDAGE (LAA), AND POSSIBLY CAUSED THE RUPTURE OF THE LAA. ALSO, COULD BE THAT INTRODUCING THE OCTARAY INTO THE ATRIUM WITH THE VERSACROSS BEING ALREADY IN THE LAA. INTERVENTION PROVIDED WAS TWO PERICARDIOCENTESIS DRAINS WERE PLACED, ARTERIAL LINE, GENERAL ANESTHESIA ALREADY ON BOARD, PRESSOR SUPPORT ALONG WITH MASSIVE BLOOD TRANSFUSION INCLUDING C

  Patient problems: Cardiac Tamponade

  MAUDE report 22811334 ↗
• MalfunctionAug 13, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH AN OCTARAY MAPPING CATHETER AND AN IRRIGATION ISSUE OCCURRED (DEVICE USED IN PATIENT). AFTER RE-INSERTING THE OCTARAY MAPPING CATHETER INTO THE BODY, IT WAS NOTICED THAT IT WAS NO LONGER IRRIGATING AND IT WAS UNABLE TO FLUSH. THE OCTARAY MAPPING CATHETER WAS REMOVED FROM THE BODY AND IT WAS FLUSHED MANUALLY WITH A SYRINGE, BUT THE ISSUE PERSISTED. THE OCTARAY MAPPING CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED WITH NO FURTHER ISSUES. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE SUSPECTED DEVICE FOR THE REPORTED FLOW/IRRIGATION ISSUE WAS THE CATHETER. THE ISSUE WAS NOT NOTED BEFORE THE DEVICE WAS USED ON THE PATIENT. IT WORKED FINE FOR THE FIRST PART OF THE CASE. NO ERROR WAS NOTED ON THE IRRIGATION PUMP. IT WAS VISUALLY DISCOVERED. THEY ¿FLUSH¿ THE CATHETER PRIOR TO INSERTION INTO THE SHEATH. THEY REPLACED THE CATHETER TO RESOLVE THE IRRIGATION ISSUE. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. NO ISSUES WITH FLOW RATE CHANGE AT THE START OF THE ABLATION. NO CHANGES WERE MADE AT THE START OF THE ABLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22798381 ↗
• MalfunctionAug 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PULMONARY VEIN ISOLATION (PVI) PROCEDURE WITH AN OCTARAY MAPPING CATHETER. THEY USED AN OCTARAY MAPPING CATHETER WITH SL0 SHEATH FOR A LEFT ATRIUM (LA) MAP. THE SL0 SHEATH WAS SUCKING AIR; THEREFORE, THE PHYSICIAN PULLED THE OCTARAY MAPPING CATHETER OUT OF THE SHEATH TO CHECK THE SHEATH. AS HE PULLED OUT THE OCTARAY MAPPING CATHETER, HE NOTICED THAT SOME COVERAGE / PLASTIC PIECE OF THE OCTARAY MAPPING CATHETER SPLINE WAS FALLING OFF ONE OF THE SPLINES AND HE WAS THEN HOLDING A PART OF THE SPLINE COVER IN HIS HAND. NO MATERIAL WAS LOST IN THE PATIENT. HOWEVER, HE THEN LOST IT ON THE TABLE OR FLOOR. THEREFORE, IT CAN NOT BE SENT BACK IN THE COMPLAINT BOX. UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO CONSEQUENCES FOR THE PATIENT. ONLY DELAY OF 5 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22743586 ↗
• InjuryAug 7, 2025Entrapment of Device; Patient Device Interaction Problem; Entrapment of Device; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION MAPPING WITH OCTARAY MAPPING CATHETER AND THE PATIENT EXPERIENCED AN INABILITY TO REMOVE THE CATHETER, BECAUSE IT WAS STUCK IN THE VALVE WHEN TRYING TO ENTER THE RIGHT VENTRICLE (RV) TO MAP FOR VENTRICULAR TACHYCARDIA (VT). THE CATHETER WAS RELEASED, BUT PART OF THE VALVE WAS STUCK ON THE CATHETER. IT WAS REPORTED THAT AN OCTARAY MAPPING CATHETER GOT STUCK IN THE TRICUSPID VALVE WHEN TRYING TO ENTER RV TO MAP A VT. THE PHYSICIAN TRIED TO PROGRESS THE VIZIGO TO RELEASE THE CATHETER BUT IT WAS NOT POSSIBLE. FINALLY, THE CATHETER WAS CAPABLE OF BEING RELEASED, BUT PART OF THE TRICUSPID VALVE WAS STUCK IN THE CATHETER. THE PATIENT SUSTAINED CONSEQUENCE CONSISTING OF TRICUSPID VALVE INSUFFICIENCY. NO OTHER MEDICAL INTERVENTION WAS NOTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GAIN CLARIFICATION AND ADDITIONAL INFORMATION ABOUT THIS EVENT WITH NO RESPONSE. SHOULD ANY NEW INFORMATION BE OBTAINED, IT WILL BE ASSESSED AND PROCESSED ACCORDINGLY.

  Patient problems: Rupture

  MAUDE report 22736631 ↗
• MalfunctionAug 3, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER (AFL) ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER AND AFTER WORKING FOR MOST OF THE CASE, TOWARD END OF THE CASE, THE CATHETER WOULD NOT FLUSH. THEY TRIED FLUSHING WITH A SYRINGE, BUT THE ISSUE PERSISTED. THE CATHETER WAS REPLACED, AND THE PROBLEM WAS RESOLVED. THE CASE CONTINUED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THEY WERE ABLE TO MAP WITH THE OCTARAY. LATER IN THE CASE, THIS HAPPENED WHEN PUTTING THE CATHETER BACK IN TO MAP. THE OCTARAY WAS NOT HOOKED UP TO A PUMP. IT WAS HOOKED UP TO A FLUSH BAG WITH AN INTRAFLOW CONNECTION OF 3ML/MIN. THERE WAS NO ERROR ON THE PUMP. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THERE WERE NO ISSUES WITH FLOW RATE CHANGE AT THE START OF ABLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22695678 ↗
• InjuryJul 8, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH A OCTARAY MAPPING CATHETER AND THE PATIENT EXPERIENCED ASYSTOLE THAT REQUIRED CHEST COMPRESSIONS AND TEMPORARY PACING. IT WAS REPORTED THAT TOWARD THE END OF THE PFA (PULSE FIELD ABLATION) AFIB PROCEDURE THE PATIENT BECAME ASYSTOLIC AFTER CARDIOVERSION. AT THE BEGINNING OF THE CASE THE PHYSICIAN USED AN OCTARAY CATHETER CREATING A PRE-PFA MAP ON THE CARTO 3 SYSTEM. THE OCTARAY WAS REMOVED AND BOSTON SCIENTIFIC FARAWAVE CATHETER WAS INSERTED, USED TO DELIVER "TOUCH-UP" PFA LESIONS AROUND THE PULMONARY VEINS AND POSTERIOR WALL. THE PATIENT HAD RECEIVED A PREVIOUS CRYO ABLATION. AFTER THE PFA PORTION THE PHYSICIAN REMAPPED WITH THE OCTARAY WHILE THE PATIENT WAS IN SINUS RHYTHM. CORONARY SINUS (CS) PACING WAS DONE, DURING WHICH THE PATIENT WENT BACK INTO AFIB RHYTHM. THE MEDICAL TEAM CARDIOVERTED THE PATIENT AND AT THIS POINT THE PATIENT WENT INTO ASYSTOLE, THIS WAS OBSERVED ON THE EP (ELECTROPHYSIOLOGY) RECORDING SYSTEM. THE PHYSICIAN ATTEMPTED TO RE-PLACE THE CS CATHETER FOR PACING, MEANWHILE A CODE WAS CALLED. CHEST COMPRESSIONS WERE ADMINISTERED, THE PATIENT WAS INTUBATED, AND A TEMPORARY PACING WIRE WAS

  Patient problems: Asystole

  MAUDE report 22438784 ↗
• InjuryJun 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) WITH AN OCTARAY MAPPING CATHETER AND EXPERIENCED A PERICARDIAL EFFUSION TREATED WITH PERICARDIOCENTESIS. A PERICARDIAL EFFUSION WAS NOTICED WHILE MAPPING THE LEFT VEIN WITH THE OCTARAY CATHETER. IT WAS NOTICED AND CONFIRMED USING INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE PATIENT HAD NO BASELINE EFFUSION AT THE BEGINNING OF THE CASE. THE PATIENT HAD NO VISIBLE SYMPTOMS, AND THE PROCEDURE WAS ABORTED. THE INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS BUT THE PERICARDIOCENTESIS WAS UNSUCCESSFUL. THE PATIENT WAS TAKEN TO THE OPERATING ROOM (OR) FOR A STERNOTOMY TO GAIN ACCESS TO THE HEART AND LOCATE THE HOLE. ADDITIONAL INFORMATION INDICATED THAT THE PATIENT DID NOT REQUIRE SURGERY. THE LAST KNOWN PATIENT STATUS WAS STABLE. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS PROCEDURE IN RELATION TO A NON-BWI TRANSSEPTAL WIRE. DURING THE PROCEDURE, ONE CATHETER EXCHANGE OCCURRED, AND ONE TRANSSEPTAL PUNCTURE SITE WAS PERFORMED. CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR, AND NO ERROR MESSAGES WERE OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. TO START THE CASE, THE SOUNDSTAR,

  Patient problems: Cardiac Tamponade

  MAUDE report 22186535 ↗
• MalfunctionJun 3, 2025Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A VIZIGO AND AN OCTARAY MAPPING CATHETER AND A STRINGY THROMBUS WAS FOUND ON BOTH DEVICES. IT WAS REPORTED THAT WHEN THE WITHDREW THE OCTARAY MAPPING CATHETER FROM THE VIZIGO SHEATH THERE WAS STRINGY THROMBUS ADHERED TO THE OCTARAY SPLINES AND INSIDE THE SHEATH AT THE PORT PART OF THE HEMOSTATIC VALVE. CALLER DID NOT KNOW IF THE THROMBUS IN THAT AREA OF THE SHEATH DUE TO THE CATHETER BEING PULLED OUT. CALLER REPLACED THE SHEATH DUE TO NO LONGER BEING ABLE TO ASPIRATE. NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22137573 ↗
• InjuryMay 14, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE REPORT INDICATED THAT DURING (PFA) PULSED FIELD ABLATION PROCEDURE WITH A NON JNJ CATHETER AND OCTARAY MAPPING CATHETER, THE PATIENT EXPERIENCED VENTRICULAR ARRHYTHMIA, WITH EPISODES OF (VT) VENTRICULAR TACHYCARDIA OR (VF) VENTRICULAR FIBRILLATION. THE REPORT INDICATED THAT DURING A PFA PROCEDURE WITH NON JNJ PFA CATHETER AND OCTARAY MAPPING CATHETER, THE PATIENT WENT INTO A VENTRICULAR ARRHYTHMIA WHILE APPLYING PULSES TO THE RIGHT INFERIOR VEIN THE PATIENT APPEARED TO INITIALLY BE IN A JUNCTIONAL RHYTHM BEFORE GOING INTO VT OR VF NOTED/DISCOVERED ON (ECG) ELECTROCARDIOGRAM MONITORING, AND IT WAS DIFFICULT TO CONFIRM THE JUNCTIONAL RHYTHM AS THE CORONARY SINUS CATHETER WAS OUT OF PLACE. THE PATIENT WAS DEFIBRILLATED TO RESTORE A NORMAL RHYTHM. THE PATIENT WENT INTO THE VT OR VF FOUR MORE TIMES NEEDING TO BE DEFIBRILLATED, AND IT IS NOT KNOWN HOW MANY JOULES WERE USED TO DEFIBRILLATE THE PATIENT. THE PATIENT WENT INTO THE VENTRICULAR RHYTHM SEVERAL MORE TIMES AFTER THE CATHETERS WERE REMOVED FROM THE BODY BUT WAS ABLE TO CONVERT TO A NORMAL RHYTHM ON THEIR OWN. THE PHYSICIAN CONSULTED WITH THE PATIENT'S CARDIOLOGIST BUT ACCORDING TO THE PHYSICIAN THE CAUSE OF THE VENTRICULAR ARR

  Patient problems: Tachycardia; Ventricular Fibrillation

  MAUDE report 22021772 ↗
• InjuryMay 7, 2025Coagulation in Device or Device Ingredient; Entrapment of Device; Patient Device Interaction Problem; Coagulation in Device or Device Ingredient; Entrapment of Device; Patient Device Interaction Problem

  THE REPORT INDICATED THAT DURING AN ATRIAL FIBRILLATION WITH WATCHMAN CARDIAC ABLATION PROCEDURE WITH OCTARAY MAPPING CATHETER, THE PATIENT EXPERIENCED THE OCTARAY CATHETER BECOMING WRAPPED ON THE EUSTACHIAN VALVE REQUIRING CUTTING OF THE CATHETER, INSERTING A SHEATH, AND ADDITIONAL STEPS TO REMOVE THE DEVICE. IT WAS REPORTED THAT AT THE BEGINNING OF THE ABLATION CASE, THE OCTARAY CATHETER BECAME WRAPPED UP IN THE EUSTACHIAN VALVE VERY TIGHTLY. THERE WERE NO ISSUES WHEN THE OCTARAY CATHETER WAS ORIGINALLY ADVANCED INTO THE RIGHT ATRIUM. HOWEVER, WHEN ATTEMPTING TO ADVANCE THE OCTARAY CATHETER INTO THE SUPERIOR VENA CAVA (SVC), IT SEEMED LIKE THE OCTARAY CATHETER WAS CAUGHT. THE MEDICAL TEAM REALIZED THAT THE OCTARAY CATHETER WAS CAUGHT WITH THE EUSTACHIAN VALVE WRAPPED AROUND THE OCTARAY SPLINES VERY TIGHTLY LIKE A "PAINTBRUSH." THE OCTARAY CATHETER WAS UNABLE TO BE ADVANCED OR PULLED BACK. THE OCTARAY CATHETER WAS ABLE TO BE PULLED BACK ABOUT 5 CENTIMETERS DOWN THE INFERIOR VENA CAVA (IVC) BUT THEN IT WOULD SPRING BACK UP INTO IT WHEN IT WAS LET GO. THE OCTARAY CATHETER WAS UNABLE TO BE DISLODGED FROM THE EUSTACHIAN VALVE, AND THE ISSUE WAS CONFIRMED ON (ICE) INTRACARDIAC ECHOCARD

  Patient problems: Foreign Body In Patient; Unspecified Tissue Injury

  MAUDE report 21979305 ↗
• MalfunctionMay 6, 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 SOME ABLATION HAD BEEN COMPLETED, AND THE MEDICAL TEAM HAD RE-INSERTED THE OCTARAY¿ CATHETER INTO THE BODY, IT WAS NOTICED THAT THE TIP OF THE OCTARAY¿ CATHETER WAS NOT IRRIGATING. THE CATHETER WAS REMOVED FROM THE BODY AND FLUSHING WAS PERFORMED WITH A SYRINGE. HOWEVER, THE CATHETER WAS OCCLUDED AND NO SOLUTION CAME OUT. THE DEVICE WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21972591 ↗
• MalfunctionFeb 11, 2025Obstruction of Flow; Material Twisted/Bent; Obstruction of Flow; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER AND AN IRRIGATION ISSUE OCCURRED. IT WAS REPORTED THERE WAS A TWIST IN THE CATHETER SHAFT AND THE CATHETER NO LONGER ¿PEARLS¿ DESPITE THE PRESSURIZED BAG. THERE WAS NO MORE IRRIGATION VISIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21356307 ↗
• MalfunctionJan 31, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A OCTARAY MAPPING CATHETER AND AN IRRIGATION ISSUE WAS IDENTIFIED. THE MEDICAL STAFF HAD THE OCTARAY CONNECTED TO A HOSPITAL ISSUED IV PUMP (ICU MEDICAL MODEL PLUM360) TO CONTROL THE RATE INSTEAD OF A MANUAL PRESSURIZED PUMP BAG, AND THE IV PUMP BEEPED TO INDICATE INADEQUATE IRRIGATION. THE CATHETER WAS ALREADY INSIDE OF THE PATIENT WHEN THE BEEPING OCCURRED, AND THE BEEPING NEVER OCCURRED PRIOR TO DEVICE INSERTION. THE ERROR READ DISTAL OCCLUSION AND WAS BEEPING, BUT WHEN THE OCTARAY WAS REMOVED FROM THE BODY AND FLUSHED, THE FLUSH PERFUSED AS EXPECTED WITH NO NOTED OCCLUSION OR COAGULATION. THE CATHETER APPEARED IN PRISTINE CONDITION. THE CATHETER WAS REMOVED, FLUSHED, THEN READVANCED MULTIPLE TIMES BEFORE ULTIMATELY THE CATHETER WAS REPLACED, AND THE ISSUE WAS RESOLVED. THERE WERE NO CARTO SYSTEM ERRORS. THE NGEN WAS SELECTED TO THE CORRECT CATHETER AND OPERATED AS EXPECTED WITH NO ISSUES. THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21285327 ↗
• InjuryJan 30, 2025Improper or Incorrect Procedure or Method; Patient Device Interaction Problem; Improper or Incorrect Procedure or Method; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PERSISTENT ATRIAL FIBRILLATION ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER AND THE PATIENT EXPERIENCED AIR EMBOLISM THAT REQUIRED HIGH OUTPUT OF OXYGEN AND PACING. IT WAS REPORTED THAT THE PATIENT SUFFERED AN AIR EMBOLISM DURING THE PROCEDURE. THE OCTARAY MAPPING CATHETER WAS NOT FLUSHED BEFORE IT WAS INSERTED INTO THE BODY. WHEN THE CATHETER WAS INSERTED INTO THE LEFT ATRIUM, THEY NOTICED THE PATIENT'S BLOOD PRESSURE DROPPED. THE PHYSICIAN REALIZED THEY HAD NOT FLUSHED THE CATHETER SO THEY IMMEDIATELY REMOVED THE CATHETER FROM THE BODY AND THE PATIENT RECOVERED WITHIN 5 MINUTES. THE ONLY MEDICAL INTERVENTION PROVIDED WAS HIGH-OUTPUT OF OXYGEN (WHILE INTUBATED AS PATIENT WAS UNDER GENERAL ANESTHESIA) AND PACING FROM THE CORONARY SINUS (CS). AFTER FLUSHING THE CATHETER, IT WAS REINSERTED AND THE PROCEDURE WAS CONTINUED WITHOUT FURTHER ISSUES. PATIENT FULLY RECOVERED. THE PHYSICIAN'S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THE PROCEDURE AND STAFF ERROR.

  Patient problems: Air Embolism; Low Blood Pressure/ Hypotension

  MAUDE report 21273262 ↗
• MalfunctionJan 22, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE AND THE OCTARAY MAPPING CATHETER WAS NOT ABLE TO FLUSH AFTER BEING USED AT THE BEGINNING OF THE CASE, AND RIGHT AT MID-CASE, WHEN IT WAS ¿REQUIRED TO BACK IN¿. THE CATHETER WAS REPLACED, AND THE PROBLEM WAS RESOLVED, AND THE CASE CONTINUED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21205063 ↗
• MalfunctionJan 12, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH OCTARAY MAPPING CATHETER AND THERE WAS AN IRRIGATION ISSUE AND THE DEVICE USED IN THE PATIENT. THEY WERE UNABLE TO FLUSH THE OCTARAY MAPPING CATHETER. THE CATHETER WAS REMOVED FROM THE BODY DURING PFA APPLICATIONS AND NOT LEFT ON A FLUSH. MULTIPLE ATTEMPTS WERE MADE TO FLUSH THE CATHETER WITHOUT RESOLUTION. THE CATHETER WAS REPLACED AND THE ISSUE RESOLVED. THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE SUSPECTED DEVICE FOR THE REPORTED FLOW/IRRIGATION ISSUE WAS THE CATHETER. NO ERROR ON THE PUMP. THEY TRIED TO FLUSH THE CATHETER BEFORE ENTERING THE BODY. CATHETER WOULD NOT FLUSH. THEY DISCONNECTED THE CATHETER FROM THE PUMP AND TRIED TO FLUSH WITH SYRINGES. STILL UNABLE TO FLUSH. AT THIS TIME THE CATHETER WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21134416 ↗
• MalfunctionJan 10, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER. AS THEY OPENED THE NEW OCTARAY MAPPING CATHETER, THERE WAS A FLUFF FOUND AROUND ONE OF THE SPLINES. PHYSICIAN DID NOT WANT TO USE IT INSIDE THE PATIENT FOR SAFETY AND INFECTION CONCERNS. THEREFORE, THEY CHANGED IT TO A NEW ONE. 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 21131695 ↗
• InjuryDec 13, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION AND THE PATIENT EXPERIENCED ST ELEVATION THAT REQUIRED MEDICATION. THE PATIENT PRESENTED A SMALL ELEVATION OF THE ST BEFORE THE BEGINNING OF THE PROCEDURE. DURING THE MAPPING PHASE, THE ST WAS WORSENING, AND SO, NITROGLYCERIDE PUFF WAS APPLIED. THE PROCEDURE WAS CONTINUED; HOWEVER, THE ST DID NOT IMPROVE AFTER THE APPLICATION OF NITROGLYCERIDE AND THE VENTRICULAR EXTRASYSTOLE ABLATION PROCEDURE WAS COMPLETED. THEREFORE, IT WAS DECIDED TO CALL THE HEMODYNAMICS SPECIALIST WHO PERFORMED A DIAGNOSTIC CATHETERIZATION WITHOUT OBSERVING ANYTHING RELEVANT. IT IS IMPORTANT TO MENTION THAT DURING THE INJECTION OF CONTRAST IN THE RIGHT CORONARY ARTERY, NO ANOMALIES WERE OBSERVED BUT THE ST WAS RECOVERED TO NORMAL LEVELS.

  Patient problems: Ischemic Heart Disease

  MAUDE report 20929967 ↗
• InjuryNov 25, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH A OCTARAY MAPPING CATHETER AND THE PATIENT EXPERIENCED HYPOTENSION AND RESPIRATORY FAILURE THAT REQUIRED MEDICATION. FIRST, IT WAS REPORTED THAT THE NGEN ETHERNET CABLE DISPLAYED PHYSICAL DAMAGE. THE PLASTIC CONNECTION TAB ON THE ETHERNET CABLE WAS BROKEN AND THE CABLE WAS UNABLE TO BE SECURED INTO THE NGEN MONITOR. NO DAMAGE TO THE OTHER NGEN COMPONENTS WERE VISIBLE. THEN IT WAS REPORTED THAT AFTER DOING A SINGLE TRANSEPTAL AND MAPPING THE LEFT ATRIUM, THE PATIENT O2 SATURATION AND BLOOD PRESSURE DROPPED. NO ABLATION HAD OCCURRED. THE PATIENT WAS PLACED ON MEDICINES TO HELP WITH SYMPTOMS AND WILL BE PERFORMING A CT SCAN FOR SUSPECTED PULMONARY THROMBUS. FURTHER INTERVENTION IS UNKNOWN. THE PATIENT FULLY RECOVERED AND DID NOT REQUIRE EXTENDED HOSPITALIZATION. THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT IS THE PATIENT CONDITION. STSF CATHETER WAS OPENED BUT NOT USED.

  Patient problems: Low Blood Pressure/ Hypotension; Respiratory Failure

  MAUDE report 20774102 ↗