DECANAVRecalls & reported problems across all models

We found 2 models of DECANAV by Biosense Webster Inc in the FDA's device registry (GUDID). Together they are named in 183 adverse event reports in the FDA's MAUDE database, received between Dec 5, 2017 and Sep 14, 2026 — classified as 5 deaths, 114 injuries, 64 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (100 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported DECANAV problems

DECANAV models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• DECANAV R7F282CT

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  4 deaths108 reports
• DECANAV R7D282CT

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  1 death75 reports

Recent DECANAV adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 14, 2026Patient Device Interaction Problem

  It was reported that a patient underwent a premature ventricular contraction ablation procedure with a DECANAV Catheter and the patient experienced cardiac perforation which required pericardiocentesis.During the mapping phase, a pericardial effusion occurred. The injury occurred when the DECANAV catheter was going up to map and perforated the left atrial appendage. The injury was confirmed by intracardiac echocardiogram. No ablation was performed. They performed a pericardial tap and removed 1.5 liters of fluid from the patient. The patient was stable and required extended hospitalization to monitor for recurrent effusion. Patient has improved.The physician¿s opinion on the cause of this adverse event is that they believe it was caused by the DECANAV perforating the left atrial appendage.

  Patient problems: Cardiac Perforation

  MAUDE report 50756271 ↗
• InjuryAug 12, 2026Patient Device Interaction Problem

  It was reported that a patient underwent a premature ventricular contraction (PVC) ablation procedure with a DECANAV Catheter and the patient experienced a cardiac tamponade which required pericardiocentesis.While mapping the right ventricle during a PVC case, an abnormal path of the DECANAV catheter through the right ventricle into the possible pericardium was noticed. Physician was immediately notified of the catheter tracing and ultrasound images. After further assessment, the physician performed pericardiocentesis and 155 mL of fluid removed by syringe and an additional 20 ml was collected in a drainage system. The patient was stable. The patient required extended hospitalization due to drain placement.There were two to three sheath and catheter exchanges during the procedure. A total of 28 ablations were performed in the right ventricle. The correct catheter settings were selected on the generator. There were no issues with flow rate change at the start of ablation. No error messages were observed on Biosense Webster equipment during the procedure.The physician stated that there was no default in the product and the event was operator error, as she put the catheter in the wron

  Patient problems: Cardiac Tamponade

  MAUDE report 50217993 ↗
• InjuryJun 25, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT) ABLATION WITH A DECANAV CATHETER AND THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION THAT REQUIRED A PERICARDIOCENTESIS. THEY NOTICED THE EFFUSION WHEN THEY WENT IN WITH INTRACARDIAC ECHOCARDIOGRAPHY (ICE) WHEN CONSIDERING GOING TRANSSEPTAL. ICE WAS THE ONLY METHOD USED TO CONFIRM THE EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED ON THE PATIENT, AND 400 ML WAS DRAINED. THE PATIENT'S LAST KNOWN STATUS WAS STABLE. NO ABLATION WAS DONE AND THERE WAS NO GENERATOR IN USE. BIOSENSE WEBSTER INC. PRODUCTS IN THE BODY AT THE TIME WERE A SOUNDSTAR® CATHETER AND A DECANAV CATHETER. ADDITIONAL INFORMATION WAS RECEIVED. TRANSSEPTAL PUNCTURE WAS NOT PERFORMED DURING THE PROCEDURE. THE PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT. PATIENT FULLY RECOVERED.

  Patient problems: Cardiac Tamponade

  MAUDE report 25626999 ↗
• DeathFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A DECANAV AND THE PATIENT HAD A CARDIAC ARREST AND PASSED AWAY. THE REPORT INDICATED THAT AFTER INDUCTION OF ANESTHESIA TO THE PATIENT, THE PATIENT WAS CARDIOVERTED DUE TO LOW BLOOD PRESSURE AND RAPID VENTRICULAR RESPONSE (RVR). THE CARDIOVERSION WAS SUCCESSFUL WITH SINUS RHYTHM. THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER WAS ADVANCED INTO THE BODY, THE EJECTION FRACTION (EF) AND BLOOD PRESSURE WERE VERY LOW. THE PATIENT HAD ELECTRICAL SIGNALS BUT NO PRESSURE. THE PATIENT HAD PULSELESS ELECTRICAL ACTIVITY (PEA), CARDIOPULMONARY RESUSCITATION (CPR) WAS STARTED, AND A CODE WAS CALLED. THE PATIENT PASSED AWAY. THE BIOSENSE WEBSTER INC. (BWI) CATHETERS USED IN THE CASE WERE THE SOUNDSTAR CATHETER (10-FRENCH) AND DECANAV CATHETER. THE BWI CATHETERS WERE BELIEVED TO BE BRAND NEW, AND THE CATHETERS WERE DISCARDED. THE REPORTER WAS UNABLE TO PROVIDE DETAILS ABOUT THE BWI CATHETERS. THE CARTO 3 SYSTEM WAS USED FOR MAPPING. NO ABLATION SYSTEM WAS SET UP. THIS EVENT WILL BE CONSERVATIVELY CODED AND REPORTED UNDER THE DECANAV CATHETER. DUE TO LIMITED INFORMATION, AND SINCE IT WAS USED DURING TH

  Patient problems: Cardiac Arrest

  MAUDE report 24397481 ↗
• MalfunctionFeb 9, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A DECANAV CATHETER AND THE MEDICAL TEAM NOTED THAT THERE WAS SIGNAL NOISE ON ALL ELECTROCARDIOGRAM SIGNALS. THERE WAS NO AVAILABLE SIGNALS TO MONITOR THE PATIENT'S HEART RHYTHM. THE CATHETER WAS REPLACED AND THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24300168 ↗
• InjuryJan 22, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) AND WATCHMAN PROCEDURE WITH A VARIPULSE¿ BI-DIRECTIONAL CATHETER AND A DECANAV CATHETER AND SUFFERED A CARDIAC PERFORATION TREATED WITH A PERICARDIOCENTESIS AND ASYSTOLE TREATED WITH MOVING THE DECANAV OUT OF THE CORONARY SINUS (CS) TO THE RIGHT VENTRICLE (RV) CHAMBER. THE REPORT INDICATED THAT AT THE END OF THE AFIB CASE WHILE PACING THE VEINS AND CHECKING FOR EXIT BLOCKS, THE PHYSICIAN WAS MOVING THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER AND NOTICED A LARGE PERICARDIAL EFFUSION. THEY WERE GETTING READY FOR THE WATCHMAN PORTION OF THE CASE. THE PERICARDIAL EFFUSION WAS CONFIRMED BY ICE. THE MEDICAL INTERVENTION PROVIDED WAS PERICARDIOCENTESIS. AFTER CHECKING THE TIME LINE, THERE WAS NO ISSUE WITH THE ABLATION, BUT THEY NOTICED THAT AT ONE POINT WITH ABLATION WAS BEING DONE ON THE LEFT SUPERIOR AND THEY WENT ASYSTOLE, THEY MOVED THE DECANAV CATHETER OUT OF THE CS AND INTO THE RV AND THE MOVEMENT MAY HAVE BEEN A BIT OUTSIDE, AND MAY HAVE PERFORATED THE RV, WHICH COULD MAY BE THE CAUSE OF THE EFFUSION. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE INFORMATION RECEIVED INDICATED THAT THE PHYSICIAN¿

  Patient problems: Cardiac Perforation

  MAUDE report 24147603 ↗
• InjuryJan 15, 2026Patient Device Interaction Problem

  AFTER CARDIAC ABLATION AND MAPPING WITH A DECANAV CATHETER, THE PATIENT EXPERIENCED BLOOD PRESSURE DROP AND PERICARDIAL PERFORATION TREATED WITH PERICARDIOCENTESIS AND 1.2LITERS OF BLOOD WAS TAPPED FROM THE PERICARDIAL SPACE AND PATIENT REQUIRED PROLONGED HOSPITALIZATION. THE REPORT INDICATED THAT THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION. AFTER PULLING THE CATHETERS ON A NON-INDUCIBLE SUPRAVENTRICULAR TACHYCARDIA (SVT), THE PATIENT'S BLOOD PRESSURE BEGAN TO DROP. THE ELECTROPHYSIOLOGIST USED A THORACIC ULTRASOUND TO DISCOVER AND CONFIRM THE PERICARDIAL EFFUSION. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND 1.2 LITERS OF BLOOD WAS TAPPED FROM THE PERICARDIAL SPACE. THE LAST KNOWN PATIENT STATUS WAS STABLE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THE RESULT OF THE PROCEDURE, AND NOT A MALFUNCTION OF BWI PRODUCTS. THE OUTCOME OF THE ADVERSE EVENT WAS THAT AS OF (B)(6) 2025, THE PATIENT¿S CONDITION IMPROVED. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF MONITORING THE PATIENT FOLLOWING PERICARDIOCENTESIS. NO CATHETER EXCHANGES OCCURRED DURING THE PROCEDURE, AND NO TRANSSEPTAL PUNCTU

  Patient problems: Cardiac Perforation

  MAUDE report 24079207 ↗
• DeathJan 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A DECANAV CATHETER AND THE PATIENT EXPERIENCED ASYSTOLE, RESPIRATORY ARREST, AND PULSELESS ELECTRICAL ACTIVITY TREATED WITH CPR. THE OUTCOME OF THE EVENT WAS THE PATIENT EXPIRED. THE REPORT INDICATED THAT DURING ELECTROPHYSIOLOGY (EP) STUDY, THE PATIENT WENT ASYSTOLE AND RESULTED IN DEATH. THE EP STUDY WAS CONDUCTED TO EITHER RULE OUT OR CONFIRM IF THE PATIENT HAD VENTRICULAR TACHYCARDIA (VT), AND THE PATIENT SHOWED SYMPTOMS OF RESPIRATORY ARREST. THE PATIENT'S HEART RATE WENT ASYSTOLE, A HOSPITAL CODE TEAM WAS SUMMONED TO THE PROCEDURE ROOM, AND CPR WAS ADMINISTERED, ALONG WITH EMERGENCY INTERVENTION. ABLATION WAS NOT USED DURING THE EP STUDY. THE DEVICES USED DURING THE STUDY WERE DECANAV CATHETER, TWO QUADRAPOLAR CATHETERS, AND CARTO 3 SYSTEM. ADDITIONAL INFORMATION INDICATED THAT THIS ADVERSE EVENT WAS DISCOVERED DURING USE OF THE PRODUCTS. THE PHYSICIAN DID SAY WHAT THE CAUSE WAS, STATING ONLY THAT THE PATIENT HAD SOME KIND OF RESPIRATORY ARREST, FOLLOWED BY A BRIEF PERIOD OF ASYSTOLE, FOLLOWED BY PULSELESS ELECTRICAL ACTIVITY (PEA). A FORCE-SENSING CATHETER WAS NOT USED IN THIS PROCEDURE.

  Patient problems: Asystole; Cardiac Arrest; Respiratory Failure

  MAUDE report 24017468 ↗
• InjuryJan 6, 2026Patient Device Interaction Problem

  DURING NON-ISCHEMIC VENTRICULAR TACHYCARDIA (ISVT) ABLATION PROCEDURE WITH A QDOT MICRO CATHETER AND DACANAV CATHETER, THE PATIENT EXPERIENCED PERICARDIAL EFFUSION (PE) TREATED WITH PERICARDIOCENTESIS AND REQUIRING PROLONGED HOSPITALIZATION. INITIALLY, THE REPORT INDICATED THAT THE CARTO 3 SYSTEM WAS DISPLAYING HIGH FORCE READINGS WHEN THEY TRIED TO ZERO THE QDOT MICRO CATHETER. THEY TRIED RE-ZEROING SEVERAL TIMES WITHOUT RESOLUTION. THE CABLE WAS REPLACED WITHOUT RESOLUTION. THE QDOT MICRO CATHETER WAS REPLACED, AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS CONTINUED. THE CUSTOMER'S REPORTED FORCE ISSUE WITH THE QDOT MICRO IS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT IS REMOTE. IT WAS ALSO REPORTED THAT AT THE END OF A NON-ISVT CASE, A PERICARDIAL EFFUSION WAS NOTICED. DURING STANDARD CHECK WHEN THEY WERE FINISHING UP THE PROCEDURE, THEY DISCOVERED THE PERICARDIAL EFFUSION. THE PERICARDIAL EFFUSION WAS CONFIRMED BY ECHO. THE MEDICAL INTERVENTION PROVIDED WAS PERICARDIOCENTESIS. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PHYSICIAN DID NOT KNOW WHAT CAUSED THE PE

  Patient problems: Cardiac Tamponade

  MAUDE report 23986309 ↗
• InjuryDec 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A DECANAV CATHETER AND SUFFERED A CARDIAC PERFORATION WHICH REQUIRED A PERICARDIOCENTESIS AND PROLONGED HOSPITALIZATION. DURING AFIB ABLATION PROCEDURE WITH A NON PFA BWI CATHETER, THE PATIENT EXPERIENCED PERICARDIAL EFFUSION TREATED WITH PERICARDIOCENTESIS. THE PATIENT WAS STABLE AND TRANSFERRED TO ICU OF OBSERVATION. DURING A PFA AFIB PROCEDURE A PERICARDIAL EFFUSION WAS DIAGNOSED VIA INTRACARDIAC ECHOCARDIOGRAPHY (ICE). PERICARDIOCENTESIS WAS PERFORMED BY THE PHYSICIAN. THE PATIENT WAS STABLE AT THE TIME OF THE CALL AND WAS TRANSFERRED TO INTENSIVE CARE UNIT (ICU) FOR OBSERVATION. THE PHYSICIAN STATED THAT HE FELT RESISTANCE WHEN PLACING THE DECANAV CATHETER INTO THE CORONARY SINUS (CS). NO OTHER DETAILS WERE AVAILABLE AT THAT TIME. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THE EVENT OCCURRED POST USE, AT THE VERY END OF THE CASE WHEN THEY WERE BACK IN THE RIGHT ATRIUM. THE TEE SHOWED "POSTERIOR" LOCATION OF THE PERFORATION. PRIOR TO NOTING THE PE/CT ABLATION WAS PERFORMED. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT THE FORCE USED WHEN TRYING TO CANNULATE

  Patient problems: Cardiac Perforation

  MAUDE report 23823826 ↗
• InjuryNov 18, 2025Patient Device Interaction Problem; Physical Resistance/Sticking; Patient Device Interaction Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTION PROCEDURE WITH A DECANAV CATHETER AND SUFFERED A CARDIAC TAMPONADE WHICH REQUIRED A PERICARDIAL DRAINAGE. IT WAS REPORTED THAT WHEN PACING WAS PERFORMED WITH THE QDOT MICRO CATHETER, THE BODY SURFACE ECG IN THE CARTO 3 AND THE LAB WAS SIGNIFICANTLY ATTENUATED, AND PACE MAP WAS UNABLE TO BE PERFORMED. THE CABLE AND THE QDOT MICRO CATHETER WERE REPLACED. AT THAT TIME, THE PATIENT¿S BLOOD PRESSURE DECREASED, AND CARDIAC TAMPONADE OCCURRED. DRAINAGE WAS PERFORMED, AND THE PROCEDURE WAS TERMINATED AS IT WAS. IT WAS UNKNOWN WHETHER REPLACING THE CABLE AND THE CATHETER IMPROVED THE ATTENUATION PROBLEM. INTRACARDIAC ECHOCARDIOGRAPHY REVEALED THE CARDIAC TAMPONADE, AND THE PERICARDIAL DRAINAGE WAS PERFORMED. THE DECANAV CATHETER AND THE QDOT MICRO CATHETER WERE MANEUVERED IN THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT), THE COLLECTED BLOOD WAS VENOUS. AFTER THE TREATMENT, THERE WERE NO PROBLEMS WITH THE PATIENT¿S CONSCIOUSNESS OR CONDITION. THE PROCEDURE WAS TERMINATED. THE PHYSICIAN ASSESSMENT OF THE HEALTH PROBLEM WAS NON-SERIOUS (MODERATE/MINOR). NO EXTENDED HOSPITALIZATION. THE CONTACT FORCE (CF) MONITORING METHO

  Patient problems: Cardiac Tamponade

  MAUDE report 23584513 ↗
• InjuryNov 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH A DECANAV CATHETER AND THE PATIENT EXPERIENCED PERICARDIAL EFFUSION TREATED WITH PERICARDIOCENTESIS. IT WAS REPORTED THAT DURING THE CASE, A PERICARDIAL EFFUSION WAS NOTICED IN THE PATIENT. WHEN INITIALLY ADVANCING THE DECANAV CATHETER INTO THE BODY FOR MAPPING, THE DECANAV CATHETER HAD ADVANCED INTO THE EPICARDIAL SPACE. THE PERICARDIAL EFFUSION WAS DISCOVERED AND CONFIRMED ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE MEDICAL INTERVENTION PROVIDED WAS PERICARDIOCENTESIS, AND ABOUT 500ML OF FLUID WAS REMOVED. THE PATIENT IS IN STABLE CONDITION. THE PHYSICIAN BELIEVES THE CAUSE OF THE PERICARDIAL EFFUSION WAS DUE TO THE DECANAV CATHETER BEING ADVANCED INTO EPICARDIAL SPACE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS FELLOW IN TRAINING CAUSED; NOT PRODUCT OR CATHETER RELATED PER MD. THE PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION. THE OUTCOME OF THE ADVERSE EVENT WAS FULLY RECOVERED (NO RESIDUAL EFFECTS). IT WAS ALSO REPORTED THAT AFTER CONTINUING THE PROCEDURE, THE CARTO 3 SYSTEM DISPLAYED ERROR 105- MAP: CATHETER SENSOR ERROR. THE CABLE WAS

  Patient problems: Cardiac Tamponade

  MAUDE report 23486832 ↗
• InjuryOct 23, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A DECANAV CATHETER AND THE PATIENT EXPERIENCED PERICARDIAL EFFUSION TREATED WITH PERICARDIOCENTESIS AND PROLONGED HOSPITALIZATION. THE PATIENT HAD JUST BEEN CARDIOVERTED WHEN THE PHYSICIAN WAS CHECKING FOR THE CATHETER LOCATION USING INTRACARDIAC ECHOCARDIOGRAPHY (ICE) WHEN THE PERICARDIAL EFFUSION WAS DISCOVERED AND CONFIRMED. PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT (ICU). THE PHYSICIAN BELIEVED THEY MAY HAVE PERFORATED WHEN ATTEMPTING TO INSERT THE DECANAV CATHETER INTO THE CORINARY SINUS (CS) DUE TO A DIFFICULT ANATOMY. THEY REPORTED THAT AFTER THEY HAD DIFFICULTY INSERTING THE DECANAV CATHETER, AND THEY DECIDED TO REMOVE THE CATHETER AND THEN WENT TRANSEPTAL WITH NO ISSUES. THEY CARDIOVERTED THE PATIENT BEFORE THEY ATTEMPTED TO REINSERT THE DECANAC AGAIN INTO THE CS. THEY WERE ABLE TO GET INTO THE CS THE 2ND TIME WITH NO ISSUES. THE PHYSICIAN THOUGHT THE PERFORATION OCCURRED DURING THE 1ST ATTEMPT TO INSERT THE DECANAV INTO THE CS, BUT THEY COULD NOT CONFIRM. THIS WAS A PFA CASE USING A FARAWAVE CATHETER WITH THE FARAPULSE SYSTEM. THE DECANAV CA

  Patient problems: Cardiac Perforation

  MAUDE report 23375385 ↗
• InjurySep 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING AN ISVT (SUPRAVENTRICULAR TACHYCARDIA) ABLATION WITH A QDOT CATHETER AND DECANAV CATHETER, THE PATIENT EXPERIENCED PERICARDIAL EFFUSION TREATED WITH PERICARDIOCENTESIS. THE PATIENT WAS STALE AFTER TREATMENT. DURING THE PROCEDURE, THE MEDICAL TEAM MAPPED THE RV (RIGHT VENTRICLE) AND GOT AN AREA OF INTEREST "SORT OF SEPTAL RV CLOSE TO THE HIS". THEY "POKED AROUND A LOT" WITH THE DECANAV CATHETER INTO THE RV APEX AND PHYSICIAN DECIDED IT WAS "GOOD ENOUGH" TO BURN. THEY HAD A GREAT SIGNAL BUT WERE UNABLE TO CAPTURE WHEN PACING IN A LOT OF AREAS IN THE RV AND THE PHYSICIAN KEPT POKING AROUND UNTIL THEY FOUND A SPOT THAT WOULD INTERMITTINGLY CAPTURE. BEFORE BURNING THEY PLACED THE DECANAV CATHETER IN THE RV TO HAVE FOR BACKUP PACING. THEY WERE NOT ABLE TO CAPTURE THE RV DUE TO THE PATIENT HAVING A "SUPER SMALL RIGHT VENTRICLE". THE PHYSICIAN SUSPECTS THEY MAY HAVE "POKED A LITTLE TOO MUCH" AND CAUSED A PERICARDIAL EFFUSION. THEY BURNED THE PVC (PREMATURE VENTRICULAR CONTRACTION) AND THE PHYSICIAN REALIZED THERE WAS A PERICARDIAL EFFUSION -- THE PHYSICIAN HAD BURNED AND DID A COUPLE OF LESIONS THEY WERE LOOKING AT IT ON ICE (INTRACARDIAC ECHOCARDIOGRAPHY) AND NOTICED THE PERICARDIA

  Patient problems: Cardiac Tamponade

  MAUDE report 23088788 ↗
• InjurySep 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTION ABLATION AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED DRAINAGE. PERICARDIAL EFFUSION WAS CONFIRMED ONE HOUR AFTER THE START OF THE PROCEDURE. DRAINAGE WAS PERFORMED. FOLLOWING THAT, ECHOCARDIOGRAPHY WAS USED TO CONFIRM THE REDUCTION OF EFFUSION, AND THE PROCEDURE WAS COMPLETED. PATIENT REQUIRED EXTENDED HOSPITALIZATION. THE PHYSICIAN ASSESSMENT OF THE HEALTH PROBLEM WAS NON SERIOUS (MODERATE/MINOR). THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT WAS THAT THE EVENT HAD POSSIBLY OCCURRED DURING MAPPING OF THE LEFT ATRIUM USING THE DECANAV CATHETER. NO ABNORMALITIES WERE OBSERVED PRIOR TO OR DURING THE PROCEDURE. SEPTAL PUNCTURE WAS PERFORMED WITH A RF NEEDLE. THE COLOR SETTING OF VISITAG WAS TAG INDEX. ADDITIONAL INFORMATION WAS RECEIVED. THE OUTCOME OF THE ADVERSE EVENT WAS IMPROVED. THE TYPE OF DELIVERED ENERGY WAS RADIO FREQUENCY (RF). NO EVIDENCE OF STEAM POP. NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. NO ISSUES WITH FLOW RATE CHANGE AT THE START OF THE ABLATION.

  Patient problems: Cardiac Tamponade

  MAUDE report 23069720 ↗

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