OCTARAY Mapping Catheter D160902Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10846835021110), received between Aug 25, 2021 and Jul 30, 2025 — classified as 9 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (11 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING ISCHEMIC VENTRICULAR TACHYCARDIA CARDIAC ABLATION WITH AN OCTARAY CATHETER, THE PATIENT EXPERIENCED PERICARDIAL EFFUSION TREATED WITH CARDIAC ASPIRATION. DURING THE ACCESS PROCESS OF THE PROCEDURE WHILE POSITIONING THE CS (CORONARY SINUS) CATHETER AND THEN DOING THE TRANSSEPTAL, THE PATIENT¿S BP (BLOOD PRESSURE) DROPPED. AN ULTRASOUND WAS DONE, AND IT WAS CONFIRMED THE PATIENT HAD A PERICARDIAL EFFUSION TREATED WITH PERICARDIAL ASPIRATION. THE PATIENT HEMODYNAMICS IMPROVED. THE DOCTOR SUSPECTED THE WIRE USED TO CANNULATE THE CS PERFORATED THE POSTERIOR WALL. NONE OF THE J&J PRODUCTS USED IN THE PROCEDURE WAS SUSPECTED TO BE THE CAUSE. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS TRANSFERRED TO CARDIAC ICU AND HAD ALREADY BEEN IN THE ICU BEFORE THE PROCEDURE.

  Patient problems: Cardiac Tamponade

  MAUDE report 22661958 ↗
• MalfunctionFeb 20, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT) PROCEDURE WITH AN OCTARAY MAPPING CATHETER. THERE WERE NO PROBLEMS IN MAPPING. AFTER THE PROCEDURE WAS COMPLETED, THE PHYSICIAN COMMENTED THAT THE HANDLE OF THE OCTARAY WAS SLICK AND ASKED THE QUESTION WHETHER ANY LUBRICATION WAS USED OR NOT. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THE GREASE LIKE MATERIAL WAS FOUND ON THE HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21419015 ↗
• MalfunctionJan 3, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A OCTARAY MAPPING CATHETER AND A FOREIGN MATERIAL WAS FOUND ON THE SPLINES. DURING THE PROCEDURE, THE PHYSICIAN NOTICED A BIT OF PLASTIC-LIKE THREAD WAS TANGLED ON THE OCTARAY MAPPING CATHETER SPLINE. INITIALLY, THEY THOUGHT IT WAS FROM THE CATHETER, BUT A CLOSER INSPECTION SHOWED NO VISIBLE DAMAGE AND THE SPLINES LOOK INTACT. THE PHYSICIAN IS CONVINCED THAT THIS MATERIAL MAY BE FROM SOMETHING ELSE, PROBABLY FROM A DILATOR, BALLOON OR AN ASD CLOSURE DEVICE. THE CASE WAS ABANDONED. THE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION RECEIVED INDICATED AN ABBOTT SL1 8.5F AND ABBOTT AGILIS LARGE CURL 8.5F WERE USED. THE PHYSICIAN DID NOT FEEL ANY RESISTANCE WHILE INTRODUCING OR RETRACTING THE CATHETER FROM THE SHEATH. THE ISSUE DID NOT RESULT IN ANY LIFTED OR SHARP RINGS. EXTENDED HOSPITAL STAY WAS NOT REQUIRED; BEDSIDE ECHO POST PROCEDURE SHOW NO OBVIOUS MATERIAL/THROMBUS IN LEFT ATRIUM (LA) OR IN CONTINUITY WITH AMPLATZER¿ SEPTAL OCCLUDER (ASD) DEVICE; NO NEUROLOGICAL DEFICIT OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21073983 ↗
• MalfunctionSep 11, 2024Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH OCTARAY MAPPING CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED TWO SPLINES BENT AND BROKEN WITH INTERNAL PARTS EXPOSED. INITIALLY IT WAS REPORTED THAT A MAGNETIC SENSOR ERROR OCCURRED. TIMING WAS WHEN INSERTING THE OCTARAY MAPPING CATHETER INTO THE PATIENT'S BODY. RECONNECTING THE CABLE AND REPLACING THE CABLE DID NOT RESOLVE THE ISSUE. UPON THE PHYSICIAN'S DECISION, SWITCHED TO DECANAV TO PERFORM THE PROCEDURE. THEN, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY PROBLEMS. NO PATIENT CONSEQUENCE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 14-AUG-2024, TWO SPLINES WERE BENT AND BROKEN WITH INTERNAL PARTS EXPOSED ON THE DEVICE. THE EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF TWO SPLINES BENT AND BROKEN WITH INTERNAL PARTS EXPOSED ON 14-AUG-2024 AND HAVE ASSESSED THIS RETURNED CONDITION AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20190798 ↗
• MalfunctionAug 27, 2024Device Contamination with Body Fluid; Device Contamination with Body Fluid

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER AND A CHAR ISSUE OCCURRED. AFTER THE ABLATION WAS CONDUCTED IN THE SUPERIOR VENA CAVA (SVC) AT 90 WATTS, WHEN THE OCTARAY MAPPING CATHETER WAS CHECKED, CHAR ON THE SPLINE WAS FOUND. THE PROCEDURE WAS CONTINUED AS IT WAS AND WAS COMPLETED. THERE WAS NO IMPACT ONTO THE PATIENT. THE PHYSICIAN¿S ASSESSMENT OF THE HEALTH PROBLEM WAS NON-SERIOUS (MODERATE/MINOR). THE PHYSICIAN'S ASSESSMENT OF THE HEALTH HAZARD AND ITS INVOLVEMENT WITH THE PRODUCT WAS A CAUSAL RELATIONSHIP WITH THE PRODUCT. THERE WERE NO ABNORMALITIES OBSERVED PRIOR TO USE OF THE PRODUCT NOR DURING USE OF THE PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED ON 06-AUG-2024. THE SYSTEM DID NOT PRESENT ANY ERROR MESSAGES NOR DID THE PHYSICIAN/USER SEE ANY PRODUCT PROBLEM. ADDITIONAL INFORMATION WAS RECEIVED ON 09-AUG-2024. NO ISSUES RELATED TO TEMPERATURE NOR FLOW ON THE CATHETER. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THE GENERATOR WAS SET TO TEMPERATURE CONTROL MODE, TEMPERATURE CUT OFF: 55, AND IMPEDANCE CUT OFF: 200O. THE DURATION OF THE ABLATION WAS NOT GREATER THAN 60 SECONDS. THE AVERAGE CONTACT FORCE WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20082077 ↗
• InjuryAug 5, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A OCTARAY MAPPING CATHETER AND EXPERIENCED VENTRICULAR TACHYCARDIA THAT REQUIRED DEFIBRILLATION. CASE WAS INTERRUPTED DUE TO LOW BLOOD PRESSURE AFTER THREE DEFIBRILLATOR SHOCKS WHERE DELIVERED TO THE PATIENTS TO TERMINATE THREE DIFFERENT VT MORPHOLOGIES. NONE OF THE BWI CATHETERS WERE DEFECTIVE OR CAUSED THE BLOOD PRESSURE ISSUE, LEADING TO THE PROCEDURE'S TERMINATION BEFOREHAND. ACCORDING TO THE PHYSICIAN, NONE OF THE BWI PRODUCTS WERE RESPONSIBLE FOR THE ADVERSE EVENT. THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT WAS PATIENT CONDITION. THE PATIENT FULLY RECOVERED AND DID NOT REQUIRE EXTENDED HOSPITALIZATION.

  Patient problems: Low Blood Pressure/ Hypotension; Tachycardia

  MAUDE report 19914107 ↗
• MalfunctionJul 16, 2024Coagulation in Device or Device Ingredient; Device Contamination with Body Fluid; Coagulation in Device or Device Ingredient; Device Contamination with Body Fluid

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER AND CHARRING OCCURRED. DURING THE PROCEDURE, WHEN THE OCTARAY MAPPING CATHETER WAS CHECKED AND CHARS WERE FOUND TO BE STUCK ON MULTIPLE SPLINES OF THE OCTARAY MAPPING CATHETER. CHARS WERE WIPED OFF AND THE OCTARAY WAS CONTINUOUSLY USED. AFTER SVC WAS AGAIN ABLATED AT 90 WATTS, WHEN THE OCTARAY MAPPING CATHETER WAS AGAIN REMOVED FROM THE PATIENT¿S BODY, CHAR WAS ATTACHED AGAIN. UNDER THE PHYSICIAN¿S DECISION, CHAR WAS WIPED OFF AND THE OCTARAY MAPPING CATHETER WAS CONTINUOUSLY USED AS WELL. THE PROCEDURE WAS COMPLETED AS IT WAS. THERE WAS NO PATIENT CONSEQUENCE. THE CHAR WAS FOUND BUT NO IMPACTS ONTO THE PATIENT COULD BE FOUND DURING THE PROCEDURE. THE PATIENT RETURNED TO THE ROOM AS SCHEDULED. THE PHYSICIAN MENTIONED THE EVENT MIGHT BE CAUSED OF PROXIMITY OF THE OCTARAY AND THE QDOT MICRO CATHETER AT THE TIME OF ABLATION. ON THE OTHER HAND, SINCE THE PHYSICIAN PAID ATTENTION MORE CAREFULLY THAN USUAL, THE PHYSICIAN HAD THE IMPRESSION THAT ADHESION OF CHAR OCCURRED MORE EASILY THAN EXPECTED. NO CHARS WERE FOUND ON THE QDOT MICRO CATHETER, BUT ONLY ON MULTIPLE SP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19752361 ↗
• MalfunctionJul 15, 2024Device Contamination with Body Fluid; Device Contamination with Body Fluid

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PULMONARY VEIN ISOLATION (PVI) CARDIAC ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER AND DURING THE CREATION OF THE POST VOLTAGE MAP, WHILE REMOVING THE OCTARAY ONCE FOR SHEATH CHANGE, A SMALL CHAR-LIKE SUBSTANCE WAS OBSERVED ADHERING TO THE OCTARAY. THE SITE OF OCCURRENCE WAS PROBABLY THE LEFT PULMONARY VEIN (LPV). HEPARIN WAS USED AS AN ANTICOAGULANT AND ACTIVATED CLOTTING TIME (ACT) VALUE WAS ABOUT 300. THERE WERE NO PROBLEMS SWITCHING BETWEEN LOW/HIGH FLOW RATES. PER THE PHYSICIAN, THE CAUSE OF CHAR IS UNKNOWN. HOWEVER, IT CANNOT BE RULED OUT THAT THERE MAY HAVE BEEN CONTACT BETWEEN QDOT AND OCTARAY. THERE WERE NO ABNORMALITIES OBSERVED PRIOR TO OR DURING THE USE OF THE PRODUCT. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19744712 ↗
• MalfunctionJun 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE BIOSENSE WEBSTER FAILURE ANALYSIS LAB RECEIVED A RETURNED BOX WITH A USED DEVICE (OCTARAY MAPPING CATHETER). THERE WAS SENDER IDENTITY. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS DEVICE. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. IN ADDITION, A SEARCH WAS ALSO PERFORMED BY THE BIOSENSE WEBSTER COMPLAINTS HANDLING UNIT AND WERE ALSO UNABLE TO IDENTIFY A COMPLAINT ASSOCIATED WITH THIS PRODUCT. THEREFORE, THIS COMPLAINT FILE WAS CREATED FOR THIS EXTRA PRODUCT RECEIVED. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB EVALUATED THIS DEVICE AND PER THE EVALUATION COMPLETION ON 07-MAY-2024, THERE WAS ONE SPLINE OF THE DEVICE BENT AND HAD DAMAGED ELECTRODES. THE ELECTRODES WERE OBSERVED DENTED AND PARTIALLY LIFTED; NO INTERNAL COMPONENTS WERE EXPOSED. BWI BECAME AWARE OF DAMAGED ELECTRODES (BENT AND PARTIALLY LIFTED) ON 07-MAY-2024 AND HAVE ASSESSED THIS RETURNED CONDITION AS REPORTABLE. THE AWARENESS DATE ON THIS RETURNED CONDITION IS 07-MAY-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19463591 ↗
• MalfunctionApr 3, 2024Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED THAT THE SHAFT WAS BROKEN EXPOSING INTERNAL WIRES. INITIALLY, IT WAS REPORTED THAT WHEN THE OCTARAY WAS CONNECTED AND IMMEDIATELY INSERTED INTO THE PATIENT¿S BODY, NOISE OCCURRED. RE-CONNECTING AND REPLACING THE CABLE DID NOT RESOLVE THE ISSUE. THE CATHETER WAS REPLACED. THOUGH THE NOISE REMAINED ON SOME ELECTRIC POTENTIALS A LITTLE, THE PHYSICIAN DETERMINED NO PROBLEM, SO THE PROCEDURE WAS CONTINUED. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. THE SIGNAL NOISE ISSUE WAS ASSESSED AS NON MDR REPORTABLE. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT WAS REMOTE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 07-MAR-2024, SHAFT WAS BROKEN EXPOSING INTERNAL WIRES. THIS WAS ASSESSED AS MDR REPORTABLE. THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING WAS 07-MAR-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19030089 ↗
• MalfunctionJan 7, 2024Device Contamination with Body Fluid; Device Contamination with Body Fluid

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH AN OCTARAY MAPPING CATHETER AND A CHAR ISSUE OCCURRED. LEFT ATRIUM WAS MAPPED WITH THE OCTARAY MAPPING CATHETER AND THE PROCEDURE WAS COMPLETED. AFTER THAT, IT WAS FOUND THAT CHAR WAS ATTACHED WHEN THE OCTARAY MAPPING CATHETER WAS PULLED OUT FROM THE SHEATH. TIMING WAS APPROXIMATELY 3 HOURS PASSED FROM THE START OF THE TREATMENT. SINCE ATTACHED CHAR WAS FOUND AFTER THE COMPLETION OF THE PROCEDURE, NO ACTION WAS TAKEN FOR THE CHAR. THERE WAS NO IMPACT ONTO THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH NO TROUBLE. ADDITIONAL INFORMATION WAS RECEIVED. THE SYSTEM DID NOT PRESENT ANY ERROR MESSAGES NOR DID THE PHYSICIAN / USER SEE ANY PRODUCT PROBLEM. THE PATIENT DID NOT EXHIBIT ANY NEUROLOGICAL SYMPTOMS SINCE THE PROCEDURE WAS COMPLETED. IT WAS LOCATED ON THE TIP OF THE SPLINE OF THE OCTARAY MAPPING CATHETER. NO ISSUES RELATED TO THE TEMPERATURE AND FLOW ON THE CATHETER. THE GENERATOR WAS SET TO POWER CONTROL MODE. THE PATIENT WAS ANTICOAGULATED. ACT WAS UNKNOWN. THE PHYSICIAN DID NOT CONSIDER THAT THE CHAR WAS EXCESSIVE. THE PHYSICIAN DOES NOT CONSIDER THE AMOUNT OF CHAR OBSERVED CAUSED A POTENTIA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18461561 ↗
• MalfunctionNov 30, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PAROXYSMAL ABLATION PROCEDURE WITH A OCTARAY, GALAXY, 48P, 2-5-2-5-2, D-CURVE AND CONSTANT ALARMS WERE RECEIVED TO INDICATE AN OCCLUSION. LIQUID DID NOT SEEM TO ENTER THE CATHETER AS THE LIQUID BACKED UP IN THE DRIP CHAMBER. THE DRIP IS SET AT 120 ML/H INITIALLY. THE MEDICAL TEAM TRIED TO REDUCE THE SPEED OF THE DRIP IN SEVERAL ROUNDS, EVEN DOWN TO 35 ML/H, BUT WITHOUT IMPROVEMENT. THE OCTARAY WAS REMOVED ON TWO OCCASIONS TO CHECK FOR A BLOCKAGE, BUT THE OCCLUSION ALARMS PERSISTED EVEN WHEN THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY. SALINE WOULD NOT DRIP FROM THE CATHETER AT ALL. NO FURTHER INFORMATION WAS PROVIDED REGARDING RESOLUTION OF THE ISSUE OR IF THE PROCEDURE WAS COMPLETED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18242027 ↗
• InjuryOct 18, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WHICH INCLUDED THE USE OF A OCTARAY MAPPING CATHETER EXPERIENCED A STROKE. THE PHYSICIAN REPORTS HE PERFORMED A PULMONARY VEIN ISOLATION (PVI) IN THE MORNING WEEKS AGO ON A PATIENT AND LATER IN THE DAY THE PATIENT HAD A STROKE. PHYSICIAN CANNOT KNOW IF IT WAS RELATED TO THE PVI PROCEDURE OR NOT, OR RELATED TO THE USE OF OCTARAY MAPPING CATHETER OR NOT. PHYSICIAN IS A RECENT USER OF THE OCTARAY MAPPING CATHETER AND IN THE PAST YEARS HAS USED THE PENTARAY CATHETER. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Stroke/CVA

  MAUDE report 17962573 ↗
• MalfunctionOct 12, 2023Device Contamination with Body Fluid; Device Contamination with Body Fluid

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED ABLATION PROCEDURE WITH A OCTARAY, GALAXY, 48P, 2-5-2-5-2, D-CURVE AND POST PROCEDURE THE MEDICAL TEAM IDENTIFIED CHAR ON THE SPLINES. THE OCTARAY WAS USED FOLLOWING THE IFU (INSTRUCTIONS FOR USE). TOTAL ABLATION TIME APPROXIMATELY 90 MINS AND RF (RADIOFREQUENCY) ENERGY WAS DELIVERED IN 35W. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17918204 ↗
• InjuryOct 1, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTION ABLATION PROCEDURE WITH AN OCTARAY, GALAXY, 48P, 2-5-2-5-2, D-CURVE. THE PATIENT EXPERIENCED CORONARY ARTERY SPASM, CARDIAC ARREST AND AIR EMBOLISM. AFTER THE PULMONARY VEIN ISOLATION (PVI), THE CAVOTRICUSPID ISHMUS (CTI) LINE WAS CHECKED AND WHEN MAPPING WAS STARTED, BLOOD PRESSURE DROPPED AND HEART STOPPED ONCE--BUT RECOVERED BY MEDICAL INTERVENTION. THE ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS; HOWEVER, NO CAUSAL RELATION WAS ESTABLISHED WITH THE EVENT AND THE PRODUCT USAGE. POSSIBILITY OF AIR EMBOLISM WAS SUSPECTED AS AN ADVERSE EVENT AS WELL. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS CORONARY ARTERY SPASM INDUCED BY PRECEDEX. INTERVENTION PROVIDED WAS TO PUT THE PATIENT ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND IMPELLA HEART PUMP. THE PATIENT WAS INTUBATED. HOWEVER, THE PATIENT BECAME VENTRICULAR TACHYCARDIC (VT), AND CARDIAC MASSAGE WAS PERFORMED. AFTER THAT, THE PATIENT LEFT THE CATHETER LAB. EXTENDED HOSPITALIZATION WAS REQUIRED AFTER THE EVENT. THE RESPIRATORY ASSISTANCE DEVICES WERE REMOVED ON (B)(6) 2023. SINCE THE EVENT IS LIFE THREATENIN

  Patient problems: Air Embolism; Cardiac Arrest; Vasoconstriction

  MAUDE report 17849544 ↗
• MalfunctionMay 30, 2023Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED ABLATION PROCEDURE WITH A OCTARAY, GALAXY, 48P, 2-5-2-5-2, D-CURVE AND AFTER GAINING ACCESS TO LEFT VENTRICLE VIA AORTIC VALVE USING OCTARAY THERE WAS RESISTANCE WITH SHEATH AND STUCK DEFLECTION. THE PHYSICIAN ELECTED TO USE AN OCTARAY CATHETER TO MAP A PVC (PREMATURE VENTRICULAR CONTRACTION) EXPECTED TO BE FROM THE LEFT VENTRILCE BASED ON THE ECG (ELECTROCARDIOGRAM) MORPHOLOGY. THEY REPORTED SOME RESISTANCE FROM THE SHEATH AS THE CATHETER SENSOR ELECTRODES EXITED THE SHEATH WHEN INSERTING. THE SHEATH WAS AN 8 FR ARROW BRAIDED SHEATH INSERTED INTO THE RIGHT FEMORAL ARTERY. THEY MAPPED THE AORTIC CUSPS WITHOUT ISSUE. WHEN ATTEMPTING TO ENTER THE LEFT VENTRICLE, THEY FLEXED THE CATHETER TO DOUBLE BACK AND USE THE HEAL OF THE CATHETER TO CROSS THE VALVE, AS PER THEIR USUAL PRACTICE. THEY WERE ABLE TO CROSS THE VALVE WITH THE HEAL OF THE CATHETER BUT FOUND WHEN STRAIGHTENING THE CATHETER THAT THE CATHETER WOULD NOT FLEX FULLY BACK TO A FULLY STRAIGHT POSITION AS DESIRED TO ALLOW THE CATHETER TIP TO ENTER THE LEFT VENTRICLE. ON PULLING BACK TO THE AORTA THEY WERE THEN UNABLE TO STRAIGHTEN THE CATHETER, WITH THE CATHETER CONFORMING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17026553 ↗
• MalfunctionMay 24, 2023Signal Artifact/Noise; Device Contamination with Body Fluid; Patient Device Interaction Problem; Signal Artifact/Noise; Device Contamination with Body Fluid; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ATRIAL FIBRILLATION (AFIB) WITH A OCTARAY, GALAXY, 48P, 2-5-2-5-2, D-CURVE AND WHEN THE OCTARAY WAS PULLED OUT OF THE PATIENT'S BODY FOR REPLACING WITH THE TV CATHETER AFTER PERFORMING THE LPV (LEFT ANTERIOR CARINA AND BOX ABLATION (BOTH AT 50 W), 2 OR 3 ELECTRODES ON OCTARAY WERE CONFIRMED TO BE TURNED BLACK AND THE CHARS WERE ATTACHED. WHEN THE ELECTRODES WERE GENTLY WIPED, THE CHARS COULD BE WIPED OFF. THE EXACT TIMING OF THE OCCURRENCE WAS NOT IDENTIFIED. HOWEVER, BECAUSE THERE WERE A FEW INTERFERENCE NOISES ON OCTARAY AND THE QDOT CATHETER DURING THE ABLATION OF THE LPV ANTERIOR CARINA AND THE ROOF (TOTAL 3 LESION) ON THE REVIEW AFTER THE PROCEDURE, AND THE CHAR ISSUE MIGHT OCCURRED AT THAT TIME. THE PHYSICIAN NOTICED THE EVENT WHEN OCTARAY WAS PULLED OUT FROM THE PATIENT'S BODY. NO IRRIGATION ISSUES WERE CONFIRMED. ALSO, THE TEMPERATURE WAS NOT DISPLAYED """"HIGH"""" DURING ABLATION. ABLATION TIME DID NOT EXCEED 60 SECONDS (PER AN ABLATION). ABLATION TIME DID NOT EXCEED 120 SECONDS (PER AN ABLATION). MEAN CF (CONTACT FORCE) VALUE EXCEEDED 25G SOMETIMES (THE EXACT VALUES WERE UNKNOWN). IRRIGATION SETTING WAS WITHIN THE RECOMMENDED RAN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16994817 ↗
• InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL TACHYCARDIA (AT) ABLATION PROCEDURE WITH AN UNKNOWN OCTARAY CATHETER AND EXPERIENCED A VESSEL PERFORATION WHICH REQUIRED A SURGICAL INTERVENTION AND A PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT A PATIENT FROM THE PREVIOUS WEEK HAD PRESENTED IN ACCIDENT & EMERGENCY (A&E) YESTERDAY WITH COMPLICATION OF AN ISCHEMIC LEG FROM THE ACCESS SITE. ANGIOGRAPHY WAS PERFORMED AND SHOWED A FLAP AT THE COMMON ARTERY, UPWARDS GOING INTO THE ILIAC. THE PROCEDURE WAS AN ATRIAL TACHY AND ARTERIAL ACCESS WAS GAINED WITH ULTRA SOUND AND 8F SHORT SHEATH, AN OCTARAY INTRODUCED WITH NO COMPLICATIONS OR DIFFICULTY TO MAP THE AORTIC ROOT. AN ANGIO SEAL WAS PLACED TO CLOSE AND NO BLEEDING AT THE SITE POST PROCEDURE. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT IT WAS PROBABLY PROCEDURE RELATED AS THE OCTARAY WAS PASSED UP THE FEMORAL ARTERY TO MAP AO ROOT. THE PATIENT FULLY RECOVERED (NO RESIDUAL EFFECTS). THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT AS THE PATIENT WAS ADMITTED ON THE (B)(6) 2023 AND DISCHARGED (B)(6). THE PATIENT NEEDED VASCULAR SURGERY TO CORRECT ILIAC DISSECTION FLAP. RELEVANT TEST

  Patient problems: Perforation of Vessels

  MAUDE report 16415414 ↗
• MalfunctionNov 9, 2022Signal Artifact/Noise; Break; Material Protrusion/Extrusion; Material Twisted/Bent; Signal Artifact/Noise; Break; Material Protrusion/Extrusion; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A AFIB ¿ PAROXYSMAL ABLATION PROCEDURE WITH AN OCTARAY, GALAXY, 48P, 2-5-2-5-2, D-CURVE AND AN ELECTRODE WAS DETACHED AND OTHER ELECTRODES ON THE SPLINE WERE DAMAGED. FROM THE BEGINNING OF THE PROCEDURE, IT WAS OBSERVED THAT THERE WERE NOISY SIGNALS ON AN ELECTRODE. THE PHYSICIAN DID NOT WANT TO REPLACE THE CABLE NOR THE CATHETER. AFTER THE CASE, THEY SAW THAT ONE SPLINE WAS BENT/CORRUGATED, THAT THE THIRD ELECTRODE OF THE SPLINE WAS MISSING, ELECTRODE TWO WAS FLATTENED, AND THAT ELECTRODE FOUR WAS ALSO PRESSED A LITTLE FLAT. AN 8 FR SHEATH WAS USED AS PER THE RECOMMENDATION. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE PATIENT WAS MONITORED WHEN THE EVENT OCCURRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT IS UNKNOWN IF THE CATHETER ELECTRODE WAS MISSING BEFORE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE AT THE TIME OF REPORTING. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED (B)(6)2022. NO FURTHER INVESTIGATION (CT & MRI) WAS PERFORMED TO THE PATIENT TO CONFIRM THAT THE MISSING ELECTRODE WAS NOT INSIDE THE PATIENT¿S BODY. NO OTHER INTERVENTION WAS PERFORMED. THE ACTUAL PATIENT OUTCOME I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15765523 ↗
• InjuryAug 16, 2022Entrapment of Device; Patient Device Interaction Problem; Entrapment of Device; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA ¿ RIGHT (IDVT) ABLATION PROCEDURE WITH AN OCTARAY, GALAXY, 48P, 2-5-2-5-2, D-CURVE AND SUFFERED A CHORDAE TENDINEAE BEING REMOVED FROM THE PATIENT. THE CATHETER WAS ENTRAPPED AND THERE WAS A 30-MINUTE DELAY IN A VT CASE. WHEN TRYING TO INTRODUCE THE OCTARAY CATHETER INTO THE RIGHT VENTRICLE, THE DEFLECTION CURVE WAS TOO SHORT (D), IT COULD ONLY GET TO THE TRICUSPID ANNULUS. THE PHYSICIAN THEN TRIED TO FORCE THE CATHETER TO GET INTO THE VENTRICLE, ROTATING AND FORCING IT SEVERAL TIMES. AT SOME POINT, HE DETECTED THE CATHETER WAS STUCK, SO HE PULLED OUT THE CATHETER. HE COULD RELEASE THE CATHETER; HOWEVER, WHEN IT WAS ALREADY OUTSIDE THE PATIENT, HE SAW, WHAT WAS TRAPPED BETWEEN THE LEGS OF THE CATHETER, WAS ONE CHORDAE TENDINEAE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 30-MINUTE DELAY. AN ECHOCARDIOGRAM WAS PERFORMED AFTER THE PROCEDURE, AND THE FUNCTIONALITY OF THE TRICUSPID ANNULUS WAS NOT COMPROMISED. FRAGMENTS WERE GENERATED AND THEY WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THIS EVENT WAS ASSESSED AS A PAPILLARY MUSCLE RUPTURE BECAUSE THE CHORDAE TENDINEAE ARE STRONG, FIBROUS CONNE

  Patient problems: Rupture

  MAUDE report 15234038 ↗
• MalfunctionApr 11, 2022Partial Blockage; Patient Device Interaction Problem; Partial Blockage; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL TACHYCARDIA ABLATION PROCEDURE WITH A OCTARAY, GALAXY, 48P, 2-5-2-5-2, D-CURVE AND A CLOT ON THE CATHETER WAS OBSERVED. DURING THE PROCEDURE, THE OCTARAY CATHETER WAS NOTED TO HAVE CLOT FORMATION AT THE LUMEN AND DID NOT IRRIGATE SUFFICIENTLY. THE ACTIVATED CLOTTING TIME (ACT) WAS MAINTAINED AT 360 THROUGHOUT THE PROCEDURE, AND IRRIGATION WAS CONFIRMED ON THE OCTARAY CATHETER BEFORE INSERTION INTO THE BODY. UPON NOTICING THE CLOT, THE PHYSICIAN TOOK A NEW CATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT AND THE PROCEDURE WAS NOT DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14079845 ↗
• InjuryMar 1, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE, WITH AN OCTARAY, GALAXY, 48P, 2-5-2-5-2, D-CURVE AND AN UNKNOWN SMART TOUCH BIDIRECTIONAL SF AND SUFFERED CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS AND PROLONGED HOSPITALIZATION. A CARDIAC TAMPONADE WAS DISCOVERED ABOUT FOUR HOURS AFTER THE PROCEDURE. THE CARDIAC TAMPONADE WAS DISCOVERED BY THE HOSPITAL STAFF LATER IN THE DAY AND WAS CONFIRMED BY ULTRASOUND. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND 400CC OF FLUID WERE REMOVED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. A SMART TOUCH SURROUND FLOW (STSF) CATHETER WAS USED IN THE CASE FOR ABLATION. THE PHYSICIAN IS UNCERTAIN OF THE CAUSE OF THE TAMPONADE. THE PHYSICIAN HAD A POTENTIAL CONCERN THAT IT WAS RELATED TO OCTARAY CATHETER. THE PATIENT HAS IMPROVED BUT REQUIRED EXTENDED HOSPITAL STAY AND REHAB AND HAS FULLY RECOVERED. THE GENERATOR USED IN THE CASE WAS A SMART ABLATE AND A BRK XS (MODEL UNAVAILABLE) WAS USED FOR TRANSSEPTAL PUNCTURE. PRIOR TO NOTING THE CARDIAC TAMPONADE, ABLATION WAS PERFORMED. THE PHYSICIAN THOUGHT A STEAM POP COULD HAVE OCCURRED BUT NO EFFUSION AFTER AND NO ASSOCIAT

  Patient problems: Cardiac Tamponade

  MAUDE report 13636706 ↗
• InjuryFeb 24, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. A CARDIAC TAMPONADE WAS DISCOVERED ABOUT 4 HOURS AFTER THE PROCEDURE. THE CARDIAC TAMPONADE WAS DISCOVERED BY THE HOSPITAL STAFF LATER IN THE DAY AND WAS CONFIRMED BY ULTRASOUND. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND 400CC OF FLUID WERE REMOVED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PHYSICIAN WAS CONCERNED THAT IT WAS CAUSED BY THE OCTARAY MAPPING CATHETER. THE PHYSICIAN IS UNCERTAIN OF CAUSE OF THE EFFUSION BUT HAD A POTENTIAL CONCERN THAT IT WAS RELATED TO THE OCTARAY MAPPING CATHETER. THE PATIENT WAS REPORTED AS FULLY RECOVERED AND DID NOT REQUIRE PROLONGED EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT. A TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A BRK XS. PRIOR TO NOTING THE CARDIAC TAMPONADE, ABLATION WAS PERFORMED. THE PHYSICIAN THOUGHT STEAM POP COULD HAVE OCCURRED BUT NO EFFUSION WAS NOTICED AFTER AND NO ASSOCIATED TEMP OR IMPEDANCE RISE OCCURRED. THE IRRIGATED CATHETER FLOW SETTINGS WERE STANDARD FLOW SETTINGS FOR STSF (1

  Patient problems: Cardiac Arrest; Cardiac Tamponade

  MAUDE report 13596690 ↗
• InjuryAug 25, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION PROCEDURE WITH AN OCTARAY, GALAXY, 48P, 2-5-2-5-2, D-CURVE AND SUFFERED FROM A FOREIGN BODY. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, A PIECE OF MYOCARDIAL TISSUE WAS ATTACHED TO THE OCTARAY SPLINES. NO PATIENT CONSEQUENCES REPORTED. THE PATIENT FULLY RECOVERED WITH NO RESIDUAL EFFECTS. THE PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT. PATIENT HAS A HISTORY OF PVCS. THE PATIENT WAS IN SINUS RHYTHM WITH PVC DURING THE ENTIRE PROCEDURE. THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THIS ADVERSE EVENT IS THAT THIS IS BIOSENSE WEBSTER INC. PRODUCT RELATED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12365601 ↗