DECANAV R7F282CTRecalls & reported problems

Summary

The FDA's MAUDE database contains 108 adverse event reports that list this exact device (DI 10846835008807), received between Feb 27, 2018 and Sep 14, 2026 — classified as 4 deaths, 60 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (52 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 108 reports, 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 ↗
• 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 ↗
• 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 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 ↗
• 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 ↗
• MalfunctionSep 5, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER (AFL) ABLATION PROCEDURE WITH A DECANAV AND DURING THE OPERATION, A SIGNAL LOSS WAS OBSERVED ON ALL ECG (BS + IC) CHANNELS. THE PHYSICIAN DID NOT HAVE ANY INTACT ECG SIGNAL AVAILABLE TO MONITOR PATIENT HEART RHYTHM. THE SIGNAL LOSS WAS OBSERVED ON CARTO® AND RECORDING SYSTEM. DURING THE SIGNAL LOSS, THE AFFECTED CATHETER WAS INSIDE THE PATIENT' S BODY. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22975572 ↗
• MalfunctionAug 27, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A DECANAV ELECTROPHYSIOLOGY CATHETER AND SIGNAL INTERFERENCE( NOISE ) WAS OBSERVED ON IC, BS, OR ALL ECG (BS + IC) CHANNELS WHILE THE DEVICE WAS INSIDE OF THE PATIENT'S BODY. THE MEDICAL TEAM CONFIRMED THAT THE PHYSICIAN HAD NO AVAILABLE MEANS WITH WHICH TO MONITOR THE PATIENT'S HEART RHYTHM. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22901752 ↗
• MalfunctionAug 25, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE WITH A DECANAV CATHETER AND THE PHYSICIAN DID NOT HAVE ANY INTACT ECG SIGNAL AVAILABLE TO MONITOR THE PATIENT¿S HEART RHYTHM. ECG SIGNAL LOSS. DURING THE PROCEDURE, THE SIGNAL LOSS WAS OBSERVED ON THE INTRACARDIAC (IC), BODY SURFACE (BS), OR ALL ECG (BS + IC) CHANNELS. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 01-AUG-2025. THE PHYSICIAN DID NOT HAVE ANY INTACT ECG SIGNAL AVAILABLE TO MONITOR THE PATIENT¿S HEART RHYTHM (EXAMPLE: BODY SURFACE, ANESTHESIA MONITOR, DEFIBRILLATOR). THE SIGNAL LOSS WAS OBSERVED ON ALL ECG (BS +IC) ON THE CARTO AND THE RECORDING SYSTEM. DURING THE SIGNAL LOSS ISSUE, THE AFFECTED CATHETER WAS INSIDE THE PATIENT¿S BODY. THIS EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE ON 01-AUG-2025 THAT THE PHYSICIAN DID NOT HAVE ANY INTACT ECG SIGNAL AVAILABLE TO MONITOR THE PATIENT¿S HEART RHYTHM AND HAVE REASSESSED THE EVENT AS REPORTABLE. THE AWARENESS DATE FOR THIS RECORD IS 01-AUG-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22886766 ↗
• InjuryAug 13, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE MAPPING WITH DECANAV CATHETER THE PATIENT EXPERIENCED BLOOD PRESSURE DROPPED, HEART RATE INCREASED AND EFFUSION TREATED WITH PERICARDIOCENTESIS. DURING THE MAPPING PORTION OF THE CASE, WHILE USING ONLY THE DECANAV FOR MAPPING, THE PATIENT¿S BLOOD PRESSURE DROPPED, AND THE HEART RATE BEGAN TO RISE. THEY IMMEDIATELY CHECKED FOR AN EFFUSION, AND ONE WAS DISCOVERED AND CONFIRMED USING THE ULTRASOUND CATHETER. THE MEDICAL INTERVENTION PROVIDED WAS PERICARDIOCENTESIS. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE CASE CONTINUED WITH THE ABLATION PORTION. THE PHYSICIAN MENTIONED THAT THE ANATOMY OF THE PATIENT WAS VERY THIN IN THE RVOT, WHICH MAY BE THE REASON FOR THE EVENT. THE CASE CONTINUED AND ENDED SUCCESSFULLY. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS THAT IT WAS RELATED TO THE PROCEDURE. THE PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION. NO GENERATOR/PUMP MALFUNCTION REPORTED. NO CATHETER EXCHANGES OCCURRED DURING THE PROCEDURE OR TRANSSEPTAL PUNCTURES NOTED. THE EVENT OCCURRED BEFORE ANY ABLATIONS WERE PERFORMED. NO STEAM POP OR CARDIAC SURGERY.

  Patient problems: Cardiac Tamponade

  MAUDE report 22800797 ↗
• MalfunctionAug 12, 2025Signal Artifact/Noise; Communication or Transmission Problem; Signal Artifact/Noise; Communication or Transmission Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A DECANAV AND A AND A SIGNAL NOISE OCCURRED ON ALL IC CHANNELS ON ALL SYSTEMS. IT WAS REPORTED THAT DURING THE OPERATION, THE SIGNAL INTERFERENCE (NOISE) WAS OBSERVED ON INTRACARDIAC (IC) CHANNELS. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. SIGNAL INTERFERENCE (NOISE) OBSERVED ON THE IC CHANNELS ON BOTH THE CARTO 3 SYSTEM AND THE RECORDING SYSTEM. THE PHYSICIAN DID NOT HAVE ANY INTACT ECG SIGNAL AVAILABLE TO MONITOR PATIENT HEART RHYTHM. THIS ISSUE OCCURRED WHILE THE AFFECTED CATHETER WAS INSIDE THE PATIENT¿S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22790469 ↗
• MalfunctionJul 9, 2025Signal Artifact/Noise; Display or Visual Feedback Problem; Signal Artifact/Noise; Display or Visual Feedback Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT) PROCEDURE WITH A DECANAV FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A BLACK FOREIGN MATERIAL ON THE TIP OF THE DEVICE. INITIALLY, IT WAS REPORTED THAT THE DECANAV CATHETER HAD NO SIGNAL OBSERVED ON THE CARTO 3 SYSTEM WHEN IT WAS CONNECTED TO THE PATIENT INTERFACE UNIT (PIU). THEY COULD NOT MAP AND COULD NOT ASSIGN SIGNALS TO THE CATHETER. THE CATHETER WAS VISUALIZED ON THE CARTO 3 SYSTEM. WHEN THE CATHETER AND CABLE WERE REPLACED, THE ISSUE WAS NOT RESOLVED. THEY REBOOTED THE PIU WITHOUT RESOLUTION. WHEN THEY EXITED THE STUDY, AND ENTERED THE SAME STUDY, THE ISSUE WAS RESOLVED AND THE PROCEDURE CONTINUED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. THE VISUALIZATION AND SIGNAL NOISE ISSUES WERE ASSESSED AS NON MDR REPORTABLE. THE RISK OF PATIENT HARM IS CONSIDERED REMOTE. THE BIOSENSE WEBSTER, INC. PAL RECEIVED THE DEVICE AND PER THE EVALUATION COMPLETION, A BLACK FOREIGN MATERIAL WAS OBSERVED ON THE TIP OF THE DEVICE. THIS WAS ASSESSED AS MDR REPORTABLE WITH AN AWARENESS DATE OF 11-JUN-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22460245 ↗
• MalfunctionJun 26, 2025Break; Manufacturing, Packaging or Shipping Problem; Break; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A DECANAV AND BEFORE THE OPERATION, THE SHAFT OF THE CATHETER WAS FOUND DAMAGED WHEN THE PACKAGE WAS JUST OPENED. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22334396 ↗
• InjuryMay 28, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA PROCEDURE (IDVT) PROCEDURE WITH A DECANAV CATHETER AND A THERMOCOOL SMARTTOUCH SF CATHETER AND THE PATIENT SUFFERED A PERICARDIAL EFFUSION TREATED WITH A PERICARDIOCENTESIS. DURING A PROCEDURE, WHILE MAPPING IN THE RIGHT VENTRICLE WITH THE DECANAV CATHETER, THE PHYSICIAN NOTICED A SMALL EFFUSION. AFTER A FEW ABLATIONS, THE EFFUSION WAS GETTING BIGGER PER INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER IMAGING AND THE PHYSICIAN ABANDONED THE ABLATION. THE PERICARDIAL EFFUSION WAS CONFIRMED WITH ICE. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND 100 CC OF FLUID WAS REMOVED. THE PATIENT IS IN A STABLE CONDITION. THE PHYSICIAN DID NOT KNOW HOW THE EFFUSION OCCURRED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION OF THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THIS ADVERSE EVENT WAS ASSESSED AS MDR REPORTABLE UNDER BOTH THE DECANAV CATHETER AND A THERMOCOOL SMARTTOUCH SF CATHETER. (B)(6).

  Patient problems: Cardiac Tamponade

  MAUDE report 22101939 ↗
• InjuryMay 7, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE REPORT INDICATED THAT AFTER CARDIAC ABLATION PROCEDURE WHICH INCLUDED THE USE OF A DECANAV CATHETER, THE PATIENT EXPERIENCED DECREASED BLOOD PRESSURE, PERICARDIAL EFFUSION (NO DRAINAGE PERFORMED BUT MEDICATION WAS PROVIDED). AFTER THE PROCEDURE, THE PATIENT'S BLOOD PRESSURE DECREASED, AND CARDIAC TAMPONADE WAS SUSPECTED. PERICARDIAL EFFUSION ACCUMULATION (NO DRAINAGE PERFORMED), AND THE ISSUE WAS NOT RESOLVED. NO EXTENDED HOSPITALIZATION WAS REQUIRED. THE PHYSICIAN'S OPINION ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT WAS THAT THERE WAS A POSSIBILITY THAT EXCESSIVE PRESSURE WAS APPLIED DURING THE LEFT VENTRICULAR (LV) MAP WITH DECANAV CATHETER. THERE WERE NO ABNORMALITIES OBSERVED PRIOR TO OR DURING USE OF THE PRODUCTS. ADDITIONAL INFORMATION RECEIVED INDICATED THAT NO DRAINAGE WAS PERFORMED. MEDICATION ADMINISTERED WERE NOREPINEPHRINE AND FLUID SUPPLY. THE PATIENT RECOVERED. DURING THE PROCEDURE, ONE CATHETER EXCHANGE WAS USED FOR EACH AREA, AND ONE TRANSSEPTAL PUNCTURE SITE WAS PERFORMED DURING THE PROCEDURE. THE PROCEDURAL ACTIVATED CLOTTING TIME (ACT) WAS 350-400 SECONDS.

  Patient problems: Pericardial Effusion

  MAUDE report 21974568 ↗
• MalfunctionApr 21, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH A DECANAV CATHETER WHICH WAS REPORTED TO HAVE KNOTTED ON ITSELF. AFTER THE INSERTION OF THE CATHETER, A FOLD WAS SEEN ON THE SHAFT OF THE CATHETER IN THE INFERIOR VENA CAVA (IVC) WITH FLUOROSCOPY. AFTER SOME MANIPULATION, THE PHYSICIAN MANAGED TO UNFOLD IT. THEY WERE ABLE TO CONTINUE THE PROCEDURE WITHOUT ANY DAMAGE TO THE CATHETER. NO CONSEQUENCE FOR THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED INDICATED THEY WERE UNABLE TO UNKNOT THE CATHETER, IF NOT, THEY WOULD NOT HAVE BEEN ABLE TO WITHDRAW IT. THERE WAS NO DETACHMENT OF COMPONENTS AND THE EVENT DID NOT RESULT IN ANY INTERNAL CATHETER COMPONENTS EXPOSED OR ANY SHARP EDGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21878690 ↗
• MalfunctionMar 4, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ISCHEMIC VENTRICULAR TACHYCARDIA (ISVT) ABLATION PROCEDURE WITH A DECANAV AND AN ECG SIGNAL LOSS OCCURRED. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT ECG SIGNALS WERE LOST AND ERROR CODE 19 "FAILURE IN PIU ECG1 CARD BIT" WAS DISPLAYED ON THE CARTO 3 SYSTEM WHEN THE CATHETER WAS CONNECTED. THE CABLE WAS REPLACED WITH NO RESOLUTION. WHEN THE CATHETER WAS REPLACED, THE ISSUE RESOLVED. THE CUSTOMER'S REPORTED ECG SIGNAL LOSS WAS 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. ON 7-FEB-2025, ADDITIONAL INFORMATION WAS RECEIVED INDICATING SIGNAL LOSS WAS OBSERVED ON ALL BODY SURFACE (BS) + INTRACARDIAC (IC) CHANNELS WHILE THE CATHETER WAS IN THE PATIENT¿S BODY. SIGNAL LOSS OCCURRENCE ON BOTH THE CARTO 3 SYSTEM AND RECORDING SYSTEM. THE PHYSICIAN DID NOT HAVE ANY INTACT ECG SIGNAL AVAILABLE TO MONITOR PATIENT HEART RHYTHM. BASED ON THIS NEW INFORMATION, THE SIGNAL LOSS ISSUE WAS REASSESSED AS AN MDR REPORTABLE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21514178 ↗
• MalfunctionJan 28, 2025

  PLUNGER NOT WORKING WHILE CATHETER WAS IN BODY. NO PATIENT HARM/CATHETER REMOVED AND MEDWATCH FORM FILLED OUT. NEW CATHETER OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21251388 ↗
• MalfunctionJan 14, 2025Break; Positioning Problem; Break; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A DECANAV, AND THE DEFLECTION MECHANISM BROKE DURING THE PROCEDURE. THE CATHETER WAS DAMAGED WHILE BEING INSERTED INTO THE BODY. THE TIP OF THE CATHETER WAS BROKEN. THERE WERE NO PIECES MISSING FROM THE CATHETER. WHEN THE CATHETER WAS REPLACED, THE ISSUE RESOLVED, AND THE PROCEDURE WAS CONTINUED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. THE DEFLECTION ISSUE IS NOT MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21154150 ↗
• InjuryJan 10, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A DECANAV AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED "DRAIN". TAMPONADE WAS OBSERVED AT THE END OF THE CASE, AFTER THE CATHETER WAS PULLED OUT FROM THE PATIENT. ACTION TAKEN WHEN THE EVENT OCCURRED WAS "DRAIN". ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE EVENT USED DURING USE OF THE BWI PRODUCTS DURING MAPPING AND ABLATION PHASE BUT OBSERVED THE TAMPONADE ONLY AT THE END OF THE CASE. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THE ADVERSE EVENT WERE BWI PRODUCT MALFUNCTION AND PATIENT CONDITION. THERE WAS NO EVIDENCE OF STEAM POP. NO SURGERY WAS REQUIRED. PATIENT WAS REPORTED TO HAVE FULLY RECOVERED.

  Patient problems: Cardiac Tamponade

  MAUDE report 21127888 ↗
• MalfunctionNov 27, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION - PAROXYSMAL ABLATION PROCEDURE WITH A DECANAV ELECTROPHYSIOLOGY CATHETER AND THE PHYSICIAN STATED THAT THE DEFLECTION MECHANISM WAS "GETTING STUCK". THE CATHETER WAS NOT DEFLECTING APPROPRIATELY. THERE WAS NO DIFFICULTY IN REMOVING THE CATHETER. THE CATHETER WAS EXCHANGED AND THE PROCEDURE WAS CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20798671 ↗
• InjuryNov 22, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH A DECANAV CATHETER AND AN OCTARAY MAPPING CATHETER. THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION THAT REQUIRED A PERICARDIOCENTESIS. A PERICARDIAL EFFUSION WAS NOTICED WITH THE PATIENT DURING THE PROCEDURE. THE PERICARDIAL EFFUSION WAS DISCOVERED WHILE THEY WERE MAPPING THE LEFT ATRIUM. THE PHYSICIAN BELIEVES THE PERICARDIAL EFFUSION OCCURRED WHEN THEY WERE GOING TRANSEPTAL. THEY NOTICED THE PATIENT¿S BLOOD PRESSURE DROPPING AND CONFIRMED IT WITH INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AND DISCOVERED THE PERICARDIAL EFFUSION. A PERICARDIOCENTESIS PROCEDURE WAS THEN PERFORMED ON THE PATIENT. THE PATIENT¿S LAST KNOWN STATUS WAS STABLE. THEY HAD THE GENERATOR READY TO GO BUT NEVER STARTED ABLATION. A DECANAV CATHETER, AN OCTARAY CATHETER AND A STERILMED SOUNDSTAR WERE USED DURING THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED. THE PHYSICIAN BELIEVES THE CAUSE OF THE ADVERSE EVENT WAS THE TRANSSEPTAL PUNCTURE. HE SAID THE PATIENT HAD AN UNUSUALLY SMALL HEART. ONE TRANSSEPTAL PUNCTURE. TO GO TRANSSEPTAL, THE PHYSICIAN USED THE VERSACROSS STEERABLE ACCESS SHEATH BY BAYLIS. THE PHYSICIAN PERFORMED A PERICARDIO

  Patient problems: Cardiac Tamponade

  MAUDE report 20755661 ↗