OPTRELL Mapping Catheter with TRUEref Technology D142901Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10846835025828), received between Nov 14, 2023 and Sep 23, 2026 — classified as 20 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (20 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Patient Device Interaction Problem

  It was reported that during a clinical study Atrial Fibrillation (AFIb) case, the patient suffered complete heart block requiring surgical intervention. Patient received an index cardiac ablation for ventricular tachycardia. On (b)(6) 2026, patient experienced complete heart block (AE#1), categorized as moderate and serious, defined by hospitalization with an admission date of (b)(6) 2026 and a discharge date of (b)(6) 2026. Relationship to study device is probable (NAVISTAR THERMOCOOL AND OPTRELL CATHETERS) and relationship to the index study procedure is probable. The adverse event is anticipated. The outcome is resolved with an end date of (b)(6) 2026. Intervention was surgery (Upgrade to a CRT-D "[Cardiac Resynchronization Therapy Defibrillator]" System. Patient had already a 1 Chamber -ICD "[Implantable Cardioverter-Defibrillator]")

  Patient problems: Heart Block

  MAUDE report 50871202 ↗
• InjuryMar 16, 2026Patient Device Interaction Problem

  A PATIENT UNDERWENT AN ISCHEMIC VENTRICULAR TACHYCARDIA (ISVT) ABLATION PROCEDURE WITH A OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND WHILE MAPPING WITH THE DEVICE, THE PATIENT EXPERIENCED BLOOD PRESSURE DROPPED/HYPOTENSION, VENTRICULAR TACHYCARDIA, VENTRICULAR FIBRILLATION TREATED WITH CARDIOVERSION, CPR AND EPINEPHRINE ADMINISTRATION. THE REPORT INDICATED THAT AFTER MAPPING THE LEFT VENTRICLE WITH THE OPTRELL CATHETER, THE PHYSICIAN INDUCED VENTRICULAR TACHYCARDIA WITH RV PACING. ANESTHESIOLOGIST THEN NOTED THAT THE PATIENT'S BLOOD PRESSURE DROPPED/HYPOTENSION. THE STAFF CARDIOVERTED THE PATIENT 7 OR 8 TIMES WITHOUT SUCCESS. THE PATIENT'S RHYTHM THEN DEGRADED TO VENTRICULAR FIBRILLATION. CPR WAS PERFORMED, ALONG WITH SEVERAL DEFIBRILLATION ATTEMPTS AND EPINEPHRINE ADMINISTRATION. THE PATIENT'S RHYTHM WAS EVENTUALLY RESTORED TO SINUS RHYTHM. THE PATIENT IS CURRENTLY STABLE.

  Patient problems: Cardiac Arrest; Tachycardia; Ventricular Fibrillation

  MAUDE report 24606801 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  DURING A CLINICAL TRIAL IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRICULAR TACHYCARDIA PROCEDURE WITH A QDOT MICRO CATHETER AND AN OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND SUFFERED A PERICARDIAL EFFUSION WHICH REQUIRED PROLONGED HOSPITALIZATION. PATIENT RECEIVED AN INDEX VENTRICULAR TACHYCARDIA CARDIAC ABLATION ON (B)(6) 2026. ON (B)(6) 2026 START DATE AND SITE AWARENESS DATE OF 06-FEB-2026, THE PATIENT EXPERIENCED PERICARDIAL EFFUSION WITHOUT HEMODYNAMIC RELEVANCE AFTER THE ABLATION PROCEDURE WITH A QDOT MICRO CATHETER CATEGORIZED AS MODERATE AND SERIOUS DEFINED BY IN PATIENT/PROLONGED HOSPITALIZATION WITH AN ADMISSION DATE OF (B)(6) 2026 AND DISCHARGED DATE OF (B)(6) 2026. RELATIONSHIP TO STUDY DEVICES (QDOT MICRO AND OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY) WAS PROBABLE AND NOT RELATED TO ALL OTHER DEVICES. THE RELATIONSHIP WITH THE INDEX STUDY PROCEDURE IS CAUSAL AND EXPECTED/ANTICIPATED. THE OUTCOME IS RESOLVED WITH AN END DATE OF (B)(6) 2026 WITH NO INTERVENTION NOTED. THE DATE THE EVENT IS FIRST REPORTED TO BE AN SERIOUS ADVERSE EVENT (SAE) IS 06-FEB-2026.

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

  MAUDE report 24513751 ↗
• MalfunctionJan 21, 2026Failure to Advance

  IT WAS REPORTED BY THE BIOSENSE WEBSTER INC REPRESENTATIVE THAT THE INTRODUCER OF THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY HAD A SMALLER FLAIR THAN THE AGILIS¿ 13F SHEATH AND THE INTRODUCER WENT INSIDE THE SHEATH AND GOT STUCK. THIS HAPPENED AT THE END OF THE CASE AND THEY PULLED EVERYTHING OUT WITHOUT ANY PROBLEMS. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24141731 ↗
• MalfunctionJan 5, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH AN OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND IRRIGATION ISSUE (DEVICE USED IN THE PATIENT) WAS OBSERVED. OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY IRRIGATION ISSUE. IMPOSSIBLE TO FLUSH. NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 09 DECEMBER 2025. THE DEVICE WAS USED IN THE PATIENT. PRESSURIZED INFUSION BAGS, SAME USED WITH ANY OTHER CATHETERS (E.G. PENTARAY, OCTARAY, ETC.). NO ERROR, DISCOVERED BY THE PHYSICIAN WHEN TAKING OUT THE CATHETER. THEY TRIED TO FLUSH BUT WAS UNSUCCESSFUL. NO ISSUES WITH FLOW RATE CHANGE AT THE START OF THE ABLATION. THE IRRIGATION ISSUE WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE ON 09-DEC-2025 THAT THE DEVICE WAS USED IN THE PATIENT AND HAVE REASSESSED THE EVENT AS REPORTABLE. THE AWARENESS DATE FOR THIS RECORD IS 09-DEC-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23970069 ↗
• InjuryJan 1, 2026Entrapment of Device; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NON-ISCHEMIC VENTRICULAR TACHYCARDIA (NON-ISVT) ABLATION PROCEDURE WITH AN OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND VIZIGO. THE OPTRELL CATHETER COULD NOT BE REMOVED FROM THE PATIENT¿S GROIN THROUGH THE VIZIGO SHEATH AND SURGICAL INTERVENTION WAS REQUIRED FOR REMOVAL. IT WAS REPORTED THAT THE RIGHT VENTRICLE (RV) CATHETER WENT THROUGH OPTRELL CATHETER AND WHEN OPTRELL WAS REMOVED, THE VIZIGO BENT INSIDE THE PATIENT AND COULD NOT BE REMOVED FROM THE PATIENT¿S GROIN. THE INTRODUCER WAS REMOVED SURGICALLY FROM THE GROIN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE SURGERY WAS DELAYED DUE TO THE REPORTED EVENT FOR THIRTY (30) MINUTES. ADDITIONAL INFORMATION INDICATED THAT THERE WAS RESISTANCE BETWEEN THE VASCULATURE; HOWEVER, THERE WAS NO ALTERATION ON SHAFT SURFACE. THE RESISTANCE RESULTED IN DAMAGE TO THE SHEATH. THERE WAS NO RESISTANCE TO SHEATH WHEN THEY WERE TRYING TO PUT THE CATHETER/DILATOR INTO THE SHEATH. THE CATHETER OR WIRE COULD NOT BE PUT THROUGH THE SHEATH. THE RESISTANCE RESULTED IN DAMAGE TO THE DILATOR THAT BENT LIKE A U-TURN. THE DILATOR/CATHETER/NEEDLE COULD NOT BE MOVED WITHIN THE SHEATH; HOWEVER, NOTHING WAS

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23938947 ↗
• InjuryDec 10, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  AFTER A SUPRAVENTRICULAR TACHYCARDIA (SVT) ABLATION PROCEDURE WITH AN OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY, THE PATIENT EXPERIENCED BLOOD PRESSURE DROP AND PERICARDIAL EFFUSION WHILE PULLING THE CATHETER TREATED INITIALLY WITH PROTAMINE FOLLOWED BY PERICARDIOCENTESIS. THE PATIENT WAS STABLE. IT WAS REPORTED AFTER AN SVT CASE, A PERICARDIAL EFFUSION WAS NOTICED. AT THE END OF THE PROCEDURE WHILE PULLING OUT THE CATHETERS, THE MEDICAL TEAM GAVE PROTAMINE THEN THEY NOTICED A DROP IN BLOOD PRESSURE ON THE PATIENT. THE PERICARDIAL EFFUSION WAS CONFIRMED BY TRANSTHORACIC ECHO. THE MEDICAL INTERVENTION PROVIDED WAS PERICARDIOCENTESIS. THEY FIRST GAVE A LITTLE MORE PROTAMINE BUT THEN ENDED UP ¿TAPPING AND DRAINING¿ THE PATIENT. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THEY DIDN¿T COMPLETE ANY ABLATION DURING THE PROCEDURE. AN OPTRELL CATHETER WAS USED FOR MAPPING. THEY ALSO USED A CARTO 3 SYSTEM, DECA NAV CATHETER AND A QUAD CATHETER DURING THE PROCEDURE. NO GENERATOR WAS USED DURING THE PROCEDURE. THE PHYSICIAN DID NOT THINK THE OPTRELL CATHETER CAUSED THE ISSUE AND BELIEVED IT WAS THE RIGHT ATRIAL OR RIGHT VENTRICULAR CATHETER. NO ADDITIONAL DETAILS OR INFORMATION

  Patient problems: Cardiac Tamponade

  MAUDE report 23770958 ↗
• MalfunctionNov 26, 2025Entrapment of Device; Appropriate Device Problem Term/Code Not Available; Entrapment of Device; Appropriate Device Problem Term/Code Not Available

  DURING VENTRICULAR TACHYCARDIA (VT)/ PREMATURE VENTRICULAR CONTRACTION (PVC) PROCEDURE, WHILE MAPPING WITH AN OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY, THE PATIENT EXPERIENCED ECTOPY, ENTANGLED WITH QUAD CATHETER AND AFTER ASSISTANCE FROM ANOTHER PHYSICIAN, IT WAS REMOVED BY BREAKING THE SPLINES. IT WAS REPORTED AT CHUM LAB A THAT DURING AN IDIOPATHIC VT\PVC ABLATION PROCEDURE, WHILE MAPPING WITH OPTRELL CATHETER, THE RV QUAD CATHETER WAS IN PLACE AFTER THE OPTRELL CATHETER WAS ADVANCED IN THE RVOT. SOME MAPPING WAS PERFORMED, WHILE THE MANIPULATION THERE WAS TOO MUCH ECTOPY, SO THE OPTRELL CATHETER WAS PULLED IN THE RIGHT ATRIUM (RA). AFTER IT WAS DIFFICULT TO DO THE MANIPULATION AND ACHIEVED TO PUT THE OPTRELL BACK IN THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT), BUT IT WAS WITH THE FAN (ELECTRODES) POINTING DOWN. THE MANIPULATION DID NOT CORRESPOND TO THE MOVEMENT ACCORDING TO THE PHYSICIAN. SHE LOOKED AT THE FLUOROSCOPY, AND THE TWO CATHETERS WERE TANGLED, AND THE QUAD WAS INSIDE ONE OF THE OPTRELL SPLINES. THE OPTRELL WAS INSERTED INSIDE THE FEMORAL SHEATH ABOUT 1 CM IN. NOTHING WAS MOVING. ANOTHER PHYSICIAN CAME TO HELP, AND THEY MANAGED TO MOVE THE OPTRELL BY BREAKING

  Patient problems: Arrhythmia

  MAUDE report 23658949 ↗
• InjuryNov 26, 2025Signal Artifact/Noise; Entrapment of Device; Patient Device Interaction Problem; Signal Artifact/Noise; Entrapment of Device; Patient Device Interaction Problem

  DURING VENTRICULAR TACHYCARDIA (VT) ABLATION PROCEDURE WITH AN OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY, THE PATIENT EXPERIENCED STACKING CATHETERS (IMPELLA PIG TAIL/OPTRELL), VT RECURRENCE REQUIRING (EXTRACORPOREAL MEMBRANE OXYGENATION) ECMO. IT WAS REPORTED THAT DURING A VT PROCEDURE WITH AN OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY, THE LEFT VENTRICULAR EJECTION FRACTION WAS LOW. MAPPING WAS PERFORMED WITH OPTRELL AFTER IMPELLA INSERTION. DURING MAPPING/INSERTION, THE PIG-TAIL PORTION OF IMPELLA AND OPTRELL WERE STACKED. ADDITIONALLY, SIGNAL NOISE OCCURRED. INTRACARDIAC ONLY, IN CARTO3 ONLY, THE CATHETER WAS IN THE PATIENT¿S BODY AT THE TIME OF THE SIGNAL NOISE, AND DURING MAPPING WITH A MULTIPOLAR CATHETER, SIGNAL NOISE OCCURRED AT ELECTRICAL POTENTIAL OCCASIONALLY. THERE WAS A POSSIBILITY OF INTERFERENCE WITH IMPELLA. THERE WAS NO HEALTH HAZARD ATTRIBUTED TO THE PRODUCT, BUT THE HISTORY OF VENTRICULAR TACHYCARDIA COULD NOT BE CONTROLLED, NECESSITATING ECMO SUPPORT. ABLATION WAS PERFORMED, BUT THE VENTRICULAR TACHYCARDIA ITSELF DID NOT STOP. BECAUSE THE VENTRICULAR TACHYCARDIA RECURRED FREQUENTLY, ECMO WAS INITIATED, AND THE PATIENT LEFT THE ROOM. THE PATIENT HAD

  Patient problems: No Clinical Signs, Symptoms or Conditions; Tachycardia

  MAUDE report 23654080 ↗
• MalfunctionOct 30, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND AN IRRIGATION ISSUE (DEVICE USED IN PATIENT) OBSERVED. DURING LEFT VENTRICLE (LV) MAPPING, THERE WAS POOR IRRIGATION. SINCE AN OCCLUSION ALERT FROM THE IRRIGATION PUMP WAS TRIGGERED, THE IRRIGATION FLOW WAS CHECKED. DUE TO OBSERVED FLOW ISSUES, THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY WAS REPLACED WITH A NEW ONE. AFTER THE REPLACEMENT, THE ISSUE WAS RESOLVED, AND THE PROCEDURE WAS CONTINUED. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED ON 09-OCT-2025. THE SUSPECTED DEVICE FOR THE REPORTED FLOW/IRRIGATION ISSUE WAS THE CATHETER. THE DEVICE WAS USED IN THE PATIENT. THE OCCLUSION ERROR WAS NOTED ON THE IRRIGATION PUMP. SINCE THE ISSUE WAS RELATED TO OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY, IT WAS NOT RELATED TO THE GENERATOR. ADDITIONAL INFORMATION WAS RECEIVED ON 19-OCT-2025. THE TERUFUSION INFUSION PUMP, TE-161S(TERUMO) WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23426271 ↗
• MalfunctionOct 29, 2025Entrapment of Device; Material Twisted/Bent; Entrapment of Device; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND THE CATHETER WAS TANGLED WITH OTHER CATHETERS AND WHEN PULLING OUT THE OPTRELL¿ CATHETER IT WAS NOTED IT HAD A BENT SHAFT. IT WAS DIFFICULT TO REMOVE THE OPTRELL CATHETER FROM THE SHEATH. THERE WAS NO DAMAGE, LIFTED RINGS, OR SHARPENED RING NOTED ON THE CATHETER. THE CATHETER WAS REPLACED, AND THE PROBLEM WAS RESOLVED. THE CASE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23416446 ↗
• MalfunctionOct 15, 2025Entrapment of Device; Entrapment of Device

  A PICTURE WAS RECEIVED FOR EVALUATION FOLLOWING JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) PROCEDURES. ACCORDING TO THE PICTURE PROVIDED BY THE CUSTOMER, THE SPLINES OF THE OPTRELL CATHETER WERE OBSERVED TWISTED/SQUASHED. THIS CONDITION COULD BE RELATED TO THE HANDLING OF THE DEVICE DURING THE PROCEDURE, SINCE ACCORDING TO THE INFORMATION PROVIDED, WHEN THE LAST CATHETER WAS MOVED FROM THE VENA CAVA INFERIOR TO THE VENTRICLE, THE HIS CATHETER WAS BY ACCIDENT MOVED AND THE TIP WENT THROUGH THE OPTRELL SPLINES. NO EXTERNAL DAMAGES WERE OBSERVED ON THE ELECTRODES OF THE OPTRELL CATHETER. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORD EVALUATION CANNOT BE PERFORMED. THE CUSTOMER COMPLAINT WAS CONFIRMED BASED ON THE PICTURE RECEIVED. THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS AND A ROOT CAUSE IS UNABLE TO BE ASSIGNED BASED ON THE CURRENT EVIDENCE. IF THE DEVICE IS RECEIVED IN THE FUTURE, THE PRODUCT INVESTIGATION WILL BE PERFORMED AND UPDATED ACCORDINGLY, AND ANY ACTION WILL BE TAKEN IF NECESSARY. AS PART OF JOHNSON & JOHNSON MEDTECH'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23296675 ↗
• InjuryAug 4, 2025Failure to Sense; Patient Device Interaction Problem; Failure to Sense; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED MEDICATION. IT WAS REPORTED THAT THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY (OPTRELL)GAVE A SENSOR ERROR FOR 20 POLE A ON THE CARTO 3 SYSTEM. RECONNECTION AND CABLE REPLACEMENT DID NOT IMPROVE THE SITUATION. THEY INTENDED TO REPLACE THE OPTRELL WITH ANOTHER NEW ONE, HOWEVER, A CARDIAC TAMPONADE OCCURRED. THE PROCEDURE WAS INTERRUPTED, AND THE PATIENT WAS MANAGED WITH AN INTRAVENOUS DRIP AND IMPROVEMENT WAS OBSERVED WITH THE ADMINISTRATION OF VASOPRESSOR MEDICATIONS. THE PHYSICIAN'S JUDGMENT ON HEALTH HAZARD WAS THAT IT WAS NON-SERIOUS (MODERATE/MINOR). THERE WAS NO EXTENDED HOSPITALIZATION. NO CAUSAL RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT. THERE WERE NO ABNORMALITIES OBSERVED PRIOR TO OR DURING USE OF THE PRODUCT. NO ABLATION WAS PERFORMED. ADVERSE EVENT OCCURRED DURING THE MAPPING PHASE. ADDITIONAL INFORMATION RECEIVED INDICATING THE ENERGY DELIVERED WAS RADIOFREQUENCY (RF). THE PATIENT DID NOT REQUIRE CARDIAC SURGERY. THE SECOND OPTRELL CATHETER, QDOT MICRO AND SOUNDSTAR CATHETER

  Patient problems: Cardiac Tamponade

  MAUDE report 22710649 ↗
• InjuryAug 3, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A REDO- ATRIAL FIBRILLATION / ATRIAL FLUTTER ABLATION (AFIB/AFL) PROCEDURE WITH AN OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY, THE PATIENT EXPERIENCED BLOOD PRESSURE DROP, PERICARDIAL EFFUSION WAS NOTED, TREATED WITH PERICARDIOCENTESIS WITH REMOVAL OF 718ML FLUID. THE CASE WAS ABORTED, BUT ATRIAL FIBRILLATION ABLATION WAS CONDUCTED PRIOR TO THE EVENT. IT WAS REPORTED THAT A PERICARDIAL EFFUSION WAS NOTICED DURING THE PROCEDURE. FOLLOWING THE ATRIAL FIBRILLATION ABLATION, THE PATIENT HAD GONE INTO EITHER ATRIAL TACHYCARDIA OR ATRIAL FLUTTER. THEN, WHILE MAPPING THE ATRIAL TACHYCARDIA OR ATRIAL FLUTTER USING AN OPTRELL CATHETER, THE PATIENT'S BLOOD PRESSURE DROPPED. A SOUNDSTAR CATHETER WAS USED TO CONFIRM THE PERICARDIAL EFFUSION WITH INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND 718 ML OF FLUID WAS DRAINED. THE PROCEDURE WAS ABORTED. THE LAST KNOWN PATIENT STATUS WAS STABLE. THE FOLLOWING BIOSENSE WEBSTER CATHETERS WERE USED DURING THE CASE: DECANAV CATHETER, OPTRELL CATHETER, SOUNDSTAR CATHETER, AND CARTO 3 SYSTEM. ALL CATHETERS ARE AVAILABLE FOR RETURN. THE CARTO 3 SYSTEM WAS USED FOR MAPPING

  Patient problems: Cardiac Tamponade

  MAUDE report 22696700 ↗
• MalfunctionJul 25, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) PROCEDURE WITH AN OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND THE CURVE WAS STUCK. IT WAS REPORTED THAT WHEN THE CATHETER WAS INSIDE OF THE BODY AND BEING STEERED BY THE PHYSICIAN, THE CATHETER WAS STUCK IN A CURVE EVEN THOUGH THE LOCK WAS NOT ON. THE PHYSICIAN WAS UNABLE TO STRAIGHTEN OUT THE CATHETER. THE CATHETER WAS REMOVED FROM THE BODY AND WAS STILL STUCK IN THE CURVE. THE CATHETER WAS REPLACED AND THE PROCEDURE CONTINUED WITH NO FURTHER ISSUES. THE FAULTY CATHETER WAS BRAND NEW. THE NGEN GENERATOR WAS USED FOR ABLATION. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE CATHETER WOULD FULLY CONTRACT WITH A LOT MORE PRESSURE THAN NORMAL AND THEN WOULD STAY CONTRACTED ON ITS OWN. THEY WATCHED THIS HAPPEN ONCE IT WAS REMOVED FROM THE BODY. THE PHYSICIAN IS EXPERIENCED WITH THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND FELT RIGHT AWAY WHEN CATHETER WAS PUT IN THAT IT WAS NOT PERFORMING NORMALLY. THE KNOB/PISTON WAS ABLE TO BE TURNED AND OR PUSHED UP AND DOWN BUT WITH A LOT OF FORCE. NO DIFFICULTY REMOVING THE CATHETER. NO RING, ELECTRODE NOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22614499 ↗
• InjuryMay 27, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ISCHEMIC VENTRICULAR TACHYCARDIA (ISVT) PROCEDURE WITH AN OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND SUFFERED AN ASYSTOLE WHICH REQUIRED PACING AND UNDERWENT BIV ICD IMPLANT. THE REPORT INDICATED THAT WHILE MAPPING THE LEFT VENTRICLE WITH THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY, THE PATIENT BECAME ASYSTOLE. THE HEART WAS PACED WITH A CORONARY SINUS (CS) CATHETER THAT WAS ALREADY IN PLACE. PATIENT IS CURRENTLY UNDERGOING A BIV ICD IMPLANT AND IS STABLE. THE INJURY WAS CONDUCTION SYSTEM ASYSTOLE DISCOVERED ON THE 12 LEAD ECG, AS WELL AS NO HEART MOVEMENT ON FLUOROSCOPY. NO ABLATION CATHETER OPENED YET, A DECAPOLAR CS, OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY IN USE. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THE ISSUE WAS THAT THE AV NODE, HIS, OR PART OF THE CONDUCTION SYSTEM JUST DROPPED OUT DUE TO MYOCARDITIS AND DOES NOT BELIEVE IT WAS A CONSEQUENCE OF MAPPING OR ANY OF THE CATHETERS IN THE HEART. NO ABLATION SYSTEM WAS USED. ADDITIONAL INFORMATION WAS RECEIVED. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS PATIENT RELATED, NOT DEVICE RELATED. THE OUTCOME OF THE ADVERSE EVENT WAS THE PATIENT¿

  Patient problems: Asystole

  MAUDE report 22092610 ↗
• InjuryMay 19, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE REPORT INDICATED THAT (SVT) SUPRAVENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY, THE PATIENT EXPERIENCED PRESSURE DROPPED AND BECAME UNSTABLE. THE PATIENT WENT INTO (PEA) PULSELESS ELECTRICAL ACTIVITY AND (CPR) CARDIOPULMONARY RESUSCITATION/CODE. THE REPORT INDICATED WHEN MAPPING IN THE LEFT VENTRICLE WITH THE OPTRELL CATHETER WHILE THE PATIENT WAS IN SUSTAINED VENTRICULAR TACHYCARDIA, THE PATIENT'S PRESSURE DROPPED AND BECAME UNSTABLE. THE PATIENT WENT INTO (PEA) PULSELESS ELECTRICAL ACTIVITY AND CPR/CODE WAS STARTED BY THE PHYSICIAN. THE PATIENT WAS STABLE AND IN SINUS RHYTHM AT THE TIME OF THE CALL. THE CASE WAS ABORTED. THE PATIENT WAS TRANSFERRED TO THE ICU FOR OBSERVATION. NO ABLATION WAS PERFORMED. NO ABLATION CATHETER WAS IN USE. A DECANAV WAS USED FOR THE CORONARY SINUS AND THE OPTRELL WAS USED FOR MAPPING. BOTH CATHETERS ARE AVAILABLE FOR RETURN. OTHER EQUIPMENT USED WAS THE NGEN GENERATOR AND CARTO 3 SYSTEM. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS PATIENT CONDITION. NO TRANSSEPTAL PUNCTURE PERFORMED, RETROGRADE AORTIC.

  Patient problems: Cardiac Arrest

  MAUDE report 22046568 ↗
• MalfunctionMay 14, 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 IDIOPATHIC VENTRICULAR TACHYCARDIA - ASC (ACUTE CORONARY SYNDROME) ABLATION PROCEDURE WITH A OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND THE MEDICAL TEAM NOTED THAT THE IRRIGATION ON THE DEVICE WAS NOT WORKING CORRECTLY. THE IRRIGATION ISSUE WAS NOTED ONLY AFTER THE DEVICE HAD BEEN USED INSIDE OF THE PATIENT. AFTER PULLING THE CATHETER OUT OF THE BODY, THE IRRIGATION BECAME DISCONNECTED (THE DEVICE HAD ITS OWN IRRIGATION LINE). BLOOD COAGULUM WAS ALSO NOTICED ON THE DEVICE. NO ERROR MESSAGES APPEARED ON THE CATHETER. THE CATHETER WAS REPLACED, AND THE PROBLEM WAS RESOLVED. THE CASE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22021713 ↗
• MalfunctionMay 7, 2025Improper or Incorrect Procedure or Method; Failure to Advance; Improper or Incorrect Procedure or Method; Failure to Advance

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRICULAR TACHYCARDIA (VT) ABLATION PROCEDURE WITH A OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND THE CATHETER WAS STUCK IN THE INTRODUCER. THE PHYSICIAN PERFORMED THE GROIN PUNCTURE. SHE INSERT THE OPTRELL CATHETER IN RIGHT FEMORAL VEIN (RFV) IN AN INTRODUCER 8F (BRAND: TERUMO, PINNACLE). NO RESISTANCE OCCURRED WHEN INTRODUCING THE OPTRELL CATHTER. THE MEDICAL TEAM THEN MAPPED THE RIGHT ATRIUM (RA) AND RIGHT VENTRICLE (RV). THE PHYSICIAN TRIED TO REMOVE THE CATHETER FROM THE RFV. THE CATHETER WAS STUCK IN THE INTRODUCER. THE PHYSICIAN DID XRAY TO CONFIRM THAT THIS OCCURRED. SHE THEN DECIDED TO KEEP THE CATHETER IN THE INTRODUCER AND REMOVE IT ALL AT THE END OF THE PROCEDURE (8H LATER). THE PHYSICIAN TOOK AN OTHER OPTRELL CATHETER TO CONTINUE THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21979127 ↗
• InjuryMar 19, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ISCHEMIC VENTRICULAR TACHYCARDIA ABLATION WITH AN OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND THE PATIENT EXPERIENCED VESSEL PERFORATION THAT DID NOT REQUIRE INTERVENTION. AFTER GOING TRANSSEPTAL AND INSERTING THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY THROUGH THE TRANSSEPTAL SHEATH, THE PHYSICIAN THOUGHT THE CATHETER WAS IN THE LEFT ATRIUM (LA) BUT WAS IN THE AORTA. THEY HAD ¿PERFORATED¿ THE AORTA. THEY TOOK A LOOK USING FLUOROSCOPY, AND THEN INTRACARDIAC ECHOCARDIOGRAPHY (ICE) IMAGING, AND NOTICED THE ISSUE. THE OR TEAM CAME IN, THE OPTRELL¿ CATHETER WAS REMOVED FROM THE BODY, AND THE PATIENT WAS MONITORED. THE PATIENT DID NOT SHOW ANY OTHER ISSUES AFTER THAT. MONITORING CONTINUED. THE PATIENT WAS IN STABLE CONDITION AT THAT TIME THE CALLER LEFT THE ROOM. NO ABLATION CATHETER WAS USED SINCE THERE WAS NO ABLATION YET COMPLETED ON THE PATIENT AT THE TIME THE INCIDENT HAPPENED. ADDITIONAL INFORMATION WAS RECEIVED. NO INTERVENTION WAS NEEDED. THE PHYSICIAN DID NOT THINK THERE WAS A BIOSENSE WEBSTER, INC. PRODUCT MALFUNCTION. THE PHYSICIAN STATED THAT IT WAS A DIFFICULT TRANSSEPTAL. ONE TRANSSEPTAL PUNCTURE SITE WAS PERFOR

  Patient problems: Perforation of Vessels

  MAUDE report 21643581 ↗
• MalfunctionMar 13, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND AN INFUSION ALARM SOUNDED. DURING PRE-MAPPING, AN ALARM FOR INFUSION PUMP BLOCKAGE SOUNDED. ALTHOUGH THE CATHETER WAS PULLED FROM THE PATIENT'S BODY, STRAIGHTENED, AND INFUSED AGAIN OUTSIDE THE PATIENT'S BODY AND TRANSFUSED AGAIN, BUT THE ALARM DID NOT STOP. THE ISSUE WAS ADDRESSED BY REPLACING THE CATHETER WITH A NEW OPTRELL BUT THE ALERT OCCURRED AT THE TIME OF FLUSHING BEFORE INSERTING THE CATHETER INTO THE PATIENT'S BODY. SINCE PERFUSION WAS ACHIEVED, CONTINUED USE WAS PERMITTED WITH THE PHYSICIAN'S APPROVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21601991 ↗
• InjuryMar 10, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH A OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND A VIZIGO AND THE PATIENT EXPERIENCED CARDIAC PERFORATION THAT REQUIRED CARDIAC SURGERY AND PROLONGED HOSPITALIZATION. A PATIENT WITH LAMIN A/C CARDIOMYOPATHY WAS ADMITTED FOR ENDO/EPI VENTRICULAR TACHYCARDIA (VT) ABLATION +/- ATRIAL TACHYCARDIA ABLATION. AFTER NIPS, THE PATIENT WAS PUT UNDER GENERAL ANESTHESIA (GA) AND VASCULAR ACCESSES GAINED. SOUND MAP WAS DONE FIRST WITH A SOUNDSTAR CATHETER, FOLLOWED BY RIGHT ATRIUM (RA) MAP. EPICARDIAL ACCESS WAS OBTAINED, FOLLOWED BY TRANSEPTAL PUNCTURE (TSP) UNDER XRAY AND TRANSESOPHAGEAL ECHOCARDIOGRAM GUIDANCE, TO GAIN ACCESS TO LEFT ATRIUM (LA)/LEFT VENTRICLE (LV). AFTER TSP, THE VIZIGO AND OPTRELL CATHETERS WERE INSERTED AND MAPPING OF THE LV STARTED. FEW SECONDS AFTER, TRANSESOPHAGEAL ECHOCARDIOGRAM (TOE) SPECIALIST REPORTED LARGER PERICARDIAL EFFUSION. VACUUM DRAIN FROM THE INITIAL EPICARDIAL ACCESS WAS FULLY OPENED, AND IT WAS OBSERVED A LARGER THAN NORMAL AMOUNT OF BLOOD BEING DRAINED. AFTER LOOKING AT THE LIMITED GEOMETRY FROM THE OPTRELL, IT WAS AGREED THAT THE CATH

  Patient problems: Cardiac Perforation

  MAUDE report 21557772 ↗
• MalfunctionFeb 26, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT) ABLATION PROCEDURE WITH A WEBSTER¿ ELECTROPHYSIOLOGY CATHETER WITH AUTO ID AND OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND THE DEVICES GOT ENTANGLED DURING THE PROCEDURE. THE PHYSICIAN WAS ATTEMPTING TO REMOVE THE OPTRELL CATHETER FROM THE VIZIGO SHEATH WHEN THE WEBSTER QUAD--THAT WAS IN THE HEART--GOT ENSNARED IN THE OPTRELL CATHETER GRID. MEANWHILE, THE OPTRELL CATHETER WAS STUCK IN THE SHEATH AND PULLED THE WEBSTER QUAD INTO THE SHEATH WITH IT. THIS EVENT DID NOT CAUSE AN INJURY TO THE PATIENT BUT WAS MORE OF A "HOLD UP" OR DELAY IN THE PROCEDURE. THE PHYSICIAN WASN'T QUITE SURE WHAT TO DO SO THEY ENDED UP CUTTING THE WEBSTER QUAD CATHETER AT THE HANDLE AND PULLED IT OUT OF THE BODY. DUE TO THE MULTIPLE MORPHOLOGIES, THE PROCEDURE WAS ABORTED AFTER THE CATHETERS WERE REMOVED FROM THE BODY. NO MEDICAL INTERVENTION WAS PERFORMED. THE PATIENT WAS UNDER AESTHESIA FOR AN UNKNOWN AMOUNT OF TIME. NO TRANSSEPTAL PUNCTURE WAS PERFORMED PRIOR TO CASE CANCELLATION. THE PATIENT'S LAST KNOWN STATUS WAS STABLE. THIS REPORT IS FOR THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY. A SEPARATE REPORT WILL B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21472631 ↗
• MalfunctionFeb 25, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH AN OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND WHILE MAPPING THE LEFT VENTRICLE FOR A VT PROCEDURE, THE OPTRELL MAPPING CATHETER GOT STUCK. THE CATHETER COULD NO LONGER BE WITHDRAWN. IN THE VISUALIZATION, THE ARMS OF THE CATHETER WERE COMPRESSED. THE CATHETER COULD ALSO NO LONGER BE ADVANCED. WITH THE HELP OF IMAGING VIA X-RAY, TEE AND CARTO, THE CATHETER COULD NOT BE FREED. THE OPERATORS THEN CUT OFF THE CATHETER AT THE HANDLE AND SLID A LONG, CONTROLLABLE SHEATH (AGILIS) OVER THE CATHETER. BY PUSHING THE SHEATH FORWARD, THE CATHETER WAS FREED AND COULD BE PULLED OUT OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS USING ONLY AN ABLATION CATHETER. THE PHYSICIANS SUSPECT THAT THE CATHETER BECAME ENTANGLED IN TRABECULAE AND TENDONS. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21465273 ↗
• InjuryFeb 4, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS AND BLOOD TRANSFUSION. AFTER THE BROCKENBROUGH TRANSSEPTAL PUNCTURE, AND IMMEDIATELY AFTER THE INSERTION OF THE CATHETERS INTO THE LEFT ATRIUM, BLOOD PRESSURE DECREASE WAS CONFIRMED. THE SOUNDSTAR ECO CATHETER REVEALED PERICARDIAL EFFUSION, AND THE PHYSICIAN DETERMINED A CARDIAC TAMPONADE AND TERMINATED THE PROCEDURE. DRAINAGE WAS PERFORMED. SIMULTANEOUSLY, ANTI-WARFARIN WAS ADMINISTERED, AND BLOOD TRANSFUSION WAS PERFORMED. CARDIAC EFFUSION WAS NO LONGER ABLE TO BE DRAINED. THE REDUCTION OF THE CARDIAC EFFUSION WAS CONFIRMED BY ECHOCARDIOGRAPHY AND BLOOD PRESSURE WAS CONFIRMED TO BE RESTORED. AFTER THE PATIENT LEFT THE ROOM, THE PATIENT WAS OBSERVED IN THE INTENSIVE CARE UNIT (ICU). THE PATIENT REQUIRED EXTENDED HOSPITALIZATION AND PATIENT STATUS IMPROVED. THE PHYSICIAN'S OPINION WAS THAT THERE WAS A POSSIBILITY THAT THE CAUSE MIGHT BE THE OPTRELL AND SOUNDSTAR ECO CATHETER WHICH WERE INSERTED IN LEFT ATRIUM AND WERE MANIPULATED. HOWEVER, THE CAUSE COULD ALSO BE THE CORONARY SINUS (CS) CATHETER WHICH WAS DIFFICULT TO BE INSERTED. T

  Patient problems: Cardiac Tamponade

  MAUDE report 21308755 ↗