DECANAV R7D282CTRecalls & reported problems

Summary

The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 10846835008791), received between Dec 5, 2017 and Feb 19, 2026 — classified as 1 death, 54 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (48 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 75 reports, in the reporter's own words as published by the FDA.

• 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 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 ↗
• 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 ↗
• 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 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 ↗
• InjurySep 12, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) CARDIAC ABLATION PROCEDURE WITH DECANAV CATHETER, THE PATIENT EXPERIENCED A CARDIAC PERFORATION AND TREATED WITH A PERICARDIOCENTESIS. THE REPORT INDICATED THAT CARDIAC PERFORATION AND PERICARDIAL EFFUSION OCCURRED DURING THE CASE. THE PHYSICIAN WAS MANIPULATING THE DECANAV CATHETER, BUT THE CATHETER WAS GOING IN A DIFFERENT PLACE THAN THE PHYSICIAN THOUGHT IT SHOULD. THE PHYSICIAN THEN LOOKED ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE), AND PERICARDIAL EFFUSION WAS NOTICED AND CONFIRMED. NO ABLATION HAD OCCURRED YET, AND THE PROCEDURE WAS ABORTED. THE MEDICAL INTERVENTION PROVIDED WAS PERICARDIOCENTESIS. THE LAST KNOWN PATIENT STATUS WAS STABLE. THE BWI DEVICES INSIDE OF THE BODY WERE THE DECANAV CATHETER AND SOUNDSTAR ICE CATHETER. THE CARTO 3 SYSTEM WAS USED FOR MAPPING. THE NGEN GENERATOR WAS SET UP FOR ABLATION BUT NO ABLATION HAD BEEN PERFORMED. ADDITIONAL INFORMATION WAS RECEIVED. THE OUTCOME OF THE ADVERSE EVENT WAS IMPROVED. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF ADMISSION TO THE INTENSIVE CARE UNIT (ICU) FOR AN ADDITIONAL STAY. NO TRANSSEPTAL PUNCTURE SITE WAS PERFORMED DURING THE PROCEDURE, AND NO TRANSSEPT

  Patient problems: Cardiac Perforation

  MAUDE report 23045695 ↗
• MalfunctionSep 5, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A DECANAV CATHETER AND DURING THE OPERATION THERE WAS ELECTROCARDIOGRAM (ECG) SIGNAL INTERFERENCE AND A RECOGNITION ISSUE. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. THIS EVENT WAS ORIGINALLY ASSESSED AS NOT MDR REPORTABLE. ADDITIONAL INFORMATION WAS RECEIVED ON 10-AUG-2025. THE CATHETER WAS INSIDE THE PATIENT¿S BODY WHEN THE SIGNAL INTERFERENCE OCCURRED. THE NOISE WAS OBSERVED ON ALL BODY SURFACE AND INTRACARDIAC ECG CHANNELS ON THE CARTO® AND RECORDING SYSTEM. THE PHYSICIAN DID NOT HAVE AN INTACT ECG SIGNAL AVAILABLE TO MONITOR THE PATIENT¿S HEART RHYTHM. PER THE ADDITIONAL INFORMATION RECEIVED, THE EVENT HAS BECOME MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22979942 ↗
• MalfunctionSep 2, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A DECANAV AND THE DEFLECTION BECAME STUCK. IT WAS ALSO REPORTED THAT THE DECANAV CATHETER WOULD NOT ADVANCE UP THE VESSEL. CALLER STATED THEY TRIED USING TWO DIFFERENT CATHETERS AND THEY WERE ABLE TO INSERT BOTH WITH NO ISSUES. WHEN THE CALLER REMOVED THE DECA NAV CATHETER, THEY DISCOVERED THE DEFLECTION WAS STUCK IN ONE DIRECTION. THE CATHETER WAS CAREFULLY AND SLOWLY ADVANCED UNDER FLOURO GUIDANCE AND WITHDRAWN MULTIPLE TIMES UNTIL IT RELEASED AND THEN IT WAS CAREFULLY WITHDRAWN FROM THE BODY. NO OTHER PHYSICAL DAMAGE OBSERVED ON THE CATHETER. 7 FR SHEATH OF AN UNKNOWN BRAND WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22946051 ↗
• InjuryAug 5, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA/WOLFFE PARKINSON WHITE (AVRT/WPW) ABLATION AND THE PATIENT EXPERIENCED CHEST PAIN AND PERICARDIAL EFFUSION THAT REQUIRED TRANSFER TO ANOTHER HOSPITAL. AFTER PACING MANEUVERS, A WPW PATHWAY WAS FOUND. THE PATIENT STARTED HAVING CHEST PAIN. PATIENT WAS SENT TO ANOTHER HOSPITAL FOR FURTHER INTERVENTION, ALTHOUGH THE SPECIFIC INTERVENTION WAS UNKNOWN. THERE WERE NO ABLATIONS, AND THEY DID NOT GO TRANSEPTAL. USING CARTO SOUND CATHETER, A PERICARDIAL EFFUSION WAS NOTED. THE X-RAY SYSTEM WAS DOWN SO THEY WERE NOT USING X-RAY. THE HARDWARE WORKED WITHIN SPECIFICATIONS AND DOES NOT WANT THE UNITS EVALUATED.

  Patient problems: Cardiac Tamponade; Chest Pain

  MAUDE report 22710989 ↗
• InjuryJul 17, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PVC (PREMATURE VENTRICULAR CONTRACTION) / IDVT (IDIOPATHIC VENTRICULAR TACHYCARDIA) ABLATION WITH A DECANAV ELECTROPHYSIOLOGY CATHETER AND THE PATIENT EXPERIENCED CARDIAC PERFORATION THAT REQUIRED PERICARDIOCENTESIS. DURING THE CASE A PERICARDIAL EFFUSION WAS NOTED. ANESTHESIA NOTICED THERE WAS A DROP IN BLOOD PRESSURE ON THE PATIENT AND THEN THE PERICARDIAL EFFUSION WAS CONFIRMED BY ICE (INTRACARDIAC ECHOCARDIOGRAPHY). THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS. THE PATIENT WAS REPORTED TO BE STABLE. PATIENT FULLY RECOVERED HOWEVER REQUIRED EXTENDED HOSPITALIZATION. THE PATIENT STAYED FOR ONE ADDITIONAL NIGHT IN THE HOSPITAL. THE PHYSICIAN STATED THE DECANAV CATHETER PERFORATED THE RIGHT VENTRICLE WHILE THEY WERE MAPPING IN THE EPICARDIAL SPACE. NO TRANSSEPTAL PUNCTURE SITES WERE PERFORMED. NO ABLATION WAS PERFORMED.

  Patient problems: Cardiac Perforation

  MAUDE report 22533131 ↗
• InjuryApr 17, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PULMONARY VEIN ISOLATION (PVI) PROCEDURE, AND THE PATIENT EXPERIENCED CARDIAC PERFORATION THAT REQUIRED PERICARDIOCENTESIS. AFTER SUCCESSFULLY COMPLETING A PVI PROCEDURE, THE PHYSICIAN PULLED OUT ALL THE CATHETERS FROM LEFT ATRIUM. WHILE RETRACTING THE AGILIS SHEATH, THE PATIENT WENT INTO TACHYCARDIA. ULTRASOUND SHOWED PERICARDIAL EFFUSION. PATIENT WAS INTUBATED WITH ADRENALINE AND "WITH A PERICARDIAL DRAINAGE" AND WAS BEING TRANSPORTED TO ANOTHER HOSPITAL TO SURGICALLY STOP THE EFFUSION. PATIENT REQUIRED EXTENDED HOSPITALIZATION. THE LOCATION OF THE PERFORATION WAS AT THE CORONARY SINUS (CS) OSTIUM. ACCORDING TO THE DOCTOR, AN ANALYSIS OF THE LOCATION OF THE TRANSSEPTAL PUNCTURE (TSP) SHOWED THAT THIS WAS TOO MUCH POSTERIOR, AND THIS MIGHT HAVE PERFORATED THE HEART. HOWEVER, IT WAS POSSIBLE TO SEE IT ONLY WHEN THE AGILIS SHEATH WAS PULLED OUT. THE DOCTOR ALSO STATED THAT DURING THE PROCEDURE, GENERAL CATHETER MANEUVERING WAS COMPLEX AND THIS MIGHT HAVE BEEN DUE TO THIS POST TRANSSEPTAL PUNCTURE. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS DUE TO TSP. AFTER SURGERY, THE PHYSICIAN BELIEVED THAT WAS DUE TO MISPLACEMENT OF

  Patient problems: Cardiac Perforation

  MAUDE report 21853207 ↗
• InjuryMar 25, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION, AND THE PATIENT EXPERIENCED PERICARDIAL EFFUSION THAT REQUIRED PERICARDIOCENTESIS. A PERICARDIAL EFFUSION WAS NOTED POST TRANSEPTAL ACCESS. ROUTINE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) IMAGING REVEALED THE ISSUE. THE PATIENT'S HEART RATE DROPPED TEMPORARILY, BUT THIS HAD NOT PROMPTED THE ICE IMAGING. A PERICARDIOCENTESIS WAS PERFORMED. AT THIS POINT, NO ABLATION HAD BEEN PERFORMED AND THE CASE WAS CANCELLED. THE PATIENT WAS REPORTED TO BE STABLE. IT WAS NOTED THE PATIENT HAS AN AORTIC ANEURYSM. THE EVENT IS BEING REPORTED UNDER THE MAPPING CATHETER, AS A CONSERVATIVE MEASURE, AS IT IS UNCLEAR WHAT CAUSED THE ADVERSE EVENT AND IF MAPPING OCCURRED PRIOR TO THE ADVERSE EVENT. THE AORTIC ANEURYSM APPEARED TO BE A PRE-EXISTING CONDITION; HOWEVER, FOLLOW UP IS REQUESTED TO CONFIRM.

  Patient problems: Cardiac Tamponade

  MAUDE report 21688577 ↗
• MalfunctionMar 19, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A DECANAV ELECTROPHYSIOLOGY CATHETER AND DURING THE OPERATION, THE DEVICE WAS UNABLE TO DEFLECT OR RELAX COMPLETELY. THE CATHETER CURVE WAS STUCK IN A DEFLECTED POSITION. THE KNOB/PISTON WAS UNABLE TO BE TURNED AND/OR PUSHED UP AND DOWN. 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 21646249 ↗
• InjuryMar 19, 2025Display or Visual Feedback Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER (AFL) ABLATION PROCEDURE WITH A DECANAV AND THE PATIENT EXPERIENCED VESSEL PERFORATION / ANEURYSM RUPTURE THAT REQUIRED PROLONGED HOSPITALIZATION. ANY OTHER INTERVENTION IS UNKNOWN. THE PATIENT EXPERIENCED A RUPTURED EXTERNAL ILIAC VEIN THAT WAS IDENTIFIED POST PROCEDURE. THE PATIENT HAD A PRE-EXISTING ANEURYSM THAT THE DECANAV CATHETER ADVANCED THROUGH AND CAUSED THE RUPTURE WITH INTERNAL BLEEDING. THE PHYSICIAN WAS ADVISED THAT THE DECANAV CATHETER WAS NOT MOVING ON THE CARTO 3 SYSTEM DISPLAY AS HE WAS ATTEMPTING TO ADVANCE IT UP THE INFERIOR VENA CAVA (IVC). THE PHYSICIAN DID NOT INTIALLY WITHDRAW THE CATHETER. THE CATHETER CABLE WAS REPLACED AND THE CARTO 3 SYSTEM CONTINUED TO DISPLAY NO MOVEMENT. THE PHYSICIAN WITHDREW THE DECANAV AND AFTER MANIPULATING THE CATHETER WAS ABLE TO ADVANCE THE DECANAV UP THE IVC. THE PATIENT WAS STABLE DURING THE PROCEDURE AND STABLE ON TRANSFER TO THE RECOVERY ROOM. THEN IT WAS REPORTED THAT THE PATIENT HAD AN ILIAC ANEURYSM RUPTURE. IT WAS UNKNOWN HOW THE INJURY WAS DISCOVERED OR WHAT TREATMENT WAS PROVIDED HOWEVER THE PATIENT HAD TO REMAIN IN THE HOSPITAL FOR FURTHER MONITORING (REQUIRE

  Patient problems: Perforation of Vessels

  MAUDE report 21644110 ↗
• InjuryFeb 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION WITH A DECANAV AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED MEDICATION AND PERICARDIOCENTESIS. BLOOD PRESSURE DECREASED DURING MAPPING. SUBSEQUENTLY, BLOOD PRESSURE RECOVERED A LITTLE. THEREFORE, THE PROCEDURE WAS CONTINUED. THE PROCEDURE WAS PERFORMED UNTIL THE COMPLETION OF THE ABLATION OF PVC ORIGINATING IN THE RIGHT VENTRICLE AND WAS COMPLETED. AT THE TIME OF THE PATIENT¿S LEAVING THE ROOM, PERICARDIAL EFFUSION COULD NOT BE CONFIRMED BY ECHOCARDIOGRAPHY. AFTER THE PATIENT LEFT THE ROOM, BLOOD PRESSURE DID NOT RECOVER. THEREFORE, NORADRENALINE WAS ADMINISTERED CONTINUOUSLY. ECHOCARDIOGRAPHY REVEALED A PERICARDIAL EFFUSION. THE PATIENT RETURNED TO THE CATHETERIZATION ROOM AGAIN AND DRAINAGE WAS PERFORMED. DID NOT REQUIRE EXTENDED HOSPITALIZATION. THE EFFUSION SEEMED TO BE VENOUS BLOOD. THE PHYSICIAN DID NOT FEEL THAT THE BW PRODUCTS WERE DIFFICULT TO USE NOR WERE DEFECTIVE. THE PATIENT WAS DEXTROCARDIA, SO THE PHYSICIAN CONSIDERED THAT THE MAJOR FACTOR OF THE CAUSE OF THE EVENT MIGHT HAVE BEEN IN THE DIFFICULTY OF COMPREHENDING ANATOMY ANALYSIS, AT THE BEGINNING OF MAPPING I

  Patient problems: Cardiac Tamponade

  MAUDE report 21402304 ↗
• MalfunctionNov 6, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR (AV) NODE ABLATION PROCEDURE WITH A DECANAV ELECTROPHYSIOLOGY CATHETER AND WHEN THE DEVICE WAS FIRST OPENED, IT WAS NOTICED THAT THERE WAS HOLE IN THE PRODUCT PACKAGING, AND THE POUCH SEAL WAS COMPROMISED. IT APPEARED AS THOUGH THE DECANAV CATHETER "PLUNGER" HAD "RUBBED THROUGH THE PACKAGING," CREATING A HOLE. THIS DEVICE WAS NEVER USED ON THE PATIENT. THE DECANAV CATHETER WAS REPLACED AND THE PROCEDURE CONTINUED WITHOUT ANY ISSUES. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20616635 ↗
• InjuryAug 26, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION WITH A DECANAV AND A THERMOCOOL SMARTTOUCH SF AND THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION THAT REQUIRED PERICARDIOCENTESIS. A PERICARDIAL EFFUSION WAS NOTICED. THE PATIENT DID NOT HAVE ANY SIGNS OR SYMPTOMS UNTIL AFTER ALL THE CATHETERS WERE REMOVED. THERE WAS A DROP IN BLOOD PRESSURE IN THE PATIENT AND THE PATIENT REPORTED CHEST PAIN. THE PATIENT WAS ALSO VOMITING. THE PERICARDIAL EFFUSION WAS CONFIRMED BY ECHO. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION. THE DOCTOR BELIEVED THAT THE CS WAS PERFORATION WITH THE DECANAV CATHETER, NOT THE ABLATION CATHETER. NO TRANSSEPTAL PUNCTURE WAS PERFORMED. ABLATION WAS PERFORMED PRIOR TO NOTING THE PERICARDIAL EFFUSION. NO EVIDENCE OF STEAM POP.

  Patient problems: Cardiac Tamponade; Heartburn/Indigestion

  MAUDE report 20072827 ↗
• InjuryAug 20, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION WITH A DECANAV ELECTROPHYSIOLOGY CATHETER AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. EFFUSION WAS CONFIRMED WHILE MAPPING THE LV APEX AREA WITH DECANAV CATHETER. THE BLOOD PRESSURE DROP WAS RESOLVED BY DRAINAGE. HEPARINIZED SALINE SOLUTION WAS ADMINISTERED AGAIN AND ACT (ACTIVATED CLOTTING TIME) WAS EXTENDED TO ACT 300. AFTER CONFIRMING THAT THERE WAS NO INCREASE IN EFFUSION, THE PROCEDURE WAS RESUMED. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER PROBLEMS. PATIENT HAS FULLY RECOVERED HOWEVER REQUIRED EXTENDED HOSPITALIZATION. AS A PERICARDIAL DRAIN WAS INSERTED, THE PATIENT REQUIRED FOLLOW UP FOR DRAIN REMOVAL. THE PHYSICIAN REPORTED THAT THERE IS A CAUSAL RELATIONSHIP WITH THE BWI PRODUCT. TOO MUCH CONTACT WAS APPLIED WHEN MAPPING WAS PERFORMED WITH DECANAV. NO ABNORMALITIES WERE OBSERVED PRIOR TO OR DURING USE OF THE PRODUCT. ATRIAL SEPTAL PUNCTURE WAS NOT PERFORMED. ABLATION WAS NOT PERFORMED PRIOR TO THE EFFUSION IDENTIFIED.

  Patient problems: Cardiac Tamponade

  MAUDE report 20003338 ↗
• MalfunctionApr 30, 2024Signal Artifact/Noise; Detachment of Device or Device Component; Material Protrusion/Extrusion; Patient Device Interaction Problem; Signal Artifact/Noise; Detachment of Device or Device Component; Material Protrusion/Extrusion; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTION CARDIAC ABLATION, WHICH INCLUDED THE USE OF A DECANAV ELECTROPHYSIOLOGY CATHETER, AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE. IT WAS ALSO REPORTED THAT ONE OF THE ELECTRODES CAME OFF WHICH APPEARED STUCK INSIDE THE SHEATH AND ANOTHER ELECTRODE WAS TORN. WHILE RIGHT VENTRICULAR (RV) MAPPING WAS DONE WITH THE FIRST DECANAV CATHETER, FAST-ANATOMICAL MAPPING (FAM) FOR RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) COULD NOT BE OBTAINED. THEREFORE, THE DECANAV CATHETER WAS REPLACED WITH THE SECOND DECANAV CATHETER (LOT# 31198319M). AFTER THE COMPLETION OF MAPPING FOR RV AND AORTA (AO) WITH THE USE OF THE SECOND DECANAV CATHETER, THE PROCEDURE WENT BACK TO RV ONCE AGAIN. WHILE MAPPING, FLUOROSCOPY REVEALED AN UNKNOWN OBJECT IN THE AGILIS SHEATH. THEREFORE, THE CATHETER AND THE SHEATH WERE REMOVED FROM THE PATIENT¿S BODY AND WERE FLUSHED TO CHECK THE INSIDE. HOWEVER, THERE WAS NOTHING FOUND. WHEN THE DECANAV CATHETER WAS INSERTED IN THE PATIENT¿S BODY FOR MAPPING AGAIN, NOISE OCCURRED ON THE ELECTRODES 3 AND 4 OF THE DECANAV. WHEN THE CATHETER WAS REMOVED OUTSIDE OF THE PATIENT¿S BODY, AND WAS CHECKED, THE 3RD ELECTRO

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

  MAUDE report 19215983 ↗
• InjuryApr 29, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA ABLATION WHICH INCLUDED THE USE OF A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH AND A DECANAV ELECTROPHYSIOLOGY CATHETER, AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS AND PROLONGED HOSPITALIZATION. THEY NOTICED A PERICARDIAL EFFUSION AFTER THE TRANSSEPTAL. HOWEVER, THEY DO NOT BELIEVE THAT IT WAS CAUSED BY THE TRANSSEPTAL. THEY WERE DONE MAPPING IN THE LV (LEFT VENTRICLE). THE EFFUSION WAS CONFIRMED BY THE SOUNDSTAR. THE MEDICAL INTERVENTION PROVIDED TO THE PATIENT WAS A PERICARDIOCENTESIS. THE PATIENT'S LAST KNOWN STATUS WAS REPORTED AS STABLE AND SPENT THE NIGHT IN THE INTENSIVE CARE UNIT (ICU) AND WAS GETTING THE DRAIN TAKEN OUT AT THE TIME OF THE CALL. THEY HAD A THERMOCOOL® SMART TOUCH® SF (STSF) CATHETER, "ALTHOUGH IT WAS NOT USED", IT WAS IN THE BODY AT ONE POINT; HOWEVER, IT WAS NOT IN THE BODY WHEN THE EFFUSION WAS NOTICED, AND NO ABLATION HAD TAKEN PLACE. THEY ALSO USED A SOUNDSTAR CATHETER, A DECANAV CATHETER AND A VIZIGO SHEATH FOR THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE ADVERSE EVENT WAS DISCOVERED DURING USE OF BWI PRODUCTS (

  Patient problems: Cardiac Tamponade

  MAUDE report 19209599 ↗
• InjuryApr 23, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRY TACHYCARDIA (AVNRT) ABLATION WITH A DECANAV ELECTROPHYSIOLOGY CATHETER AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS AND SURGICAL INTERVENTION. POST PROCEDURE WHEN THE PATIENT WAS GETTING READY FOR DISCHARGE, THE PATIENT WENT INTO TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED UNSUCCESSFULLY REMOVING 1200 CC'S OF FLUID. THE PATIENT WAS THEN TAKEN TO SURGERY. AFTER TREATMENT, THE PATIENT WAS IN STABLE CONDITION. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS PROCEDURE RELATED. AFTER PLACING THE DECANAV INTO THE CORONARY SINUS (CS), IT FLIPPED INTO THE VENTRICLE. NO TRANSSEPTAL PUNCTURE WAS PERFORMED. ABLATION WAS PERFORMED PRIOR TO NOTING PERICARDIAL EFFUSION. NO EVIDENCE OF STEAM POP. NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE PATIENT RECOVERED AND DISCHARGED HOME BUT REQUIRED EXTENDED HOSPITALIZATION DUE TO SURGICAL INTERVENTION (OPEN STERNOTOMY).

  Patient problems: Cardiac Tamponade

  MAUDE report 19165608 ↗
• InjuryApr 16, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A DECANAV ELECTROPHYSIOLOGY CATHETER AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE TREATED WITH A PERICARDIOCENTESIS AND 450 CCS OF FLUID WAS DRAINED. WHEN CHECKING INTRACARDIAC ECHOCARDIOGRAPHY (ICE) POST-PROCEDURE, THEY SAW AN EFFUSION. THE PATIENT'S BLOOD PRESSURE DROPPED AND THE PATIENT BEGAN COMPLAINING OF CHEST PAIN. CONFIRMED EFFUSION USING BOTH ICE AND AN EXTERNAL ECHOCARDIOGRAM. THE PATIENT WAS GOING TO THE INTENSIVE CARE UNIT (ICU) FOR OBSERVATION. PATIENT OUTCOME WAS IMPROVED. NO TRANSSEPTAL PUNCTURE PERFORMED. NO EVIDENCE OF STEAM POP. EVENT OCCURRED DURING MAPPING AND NO ABLATION HAD OCCURRED. ON (B)(6) 2024, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE QDOT MICRO¿ CATHETER WAS NOT IN THE BODY YET AT THE TIME OF INCIDENT AS PREVIOUSLY REPORTED. IT WAS LATER CLARIFIED THAT THE SOUNDSTAR AND CS CATHETERS WERE IN THE BODY AT THE TIME OF INCIDENT. AS SUCH, THE EVENT IS BEING REPORTED AGAINST THE DECANAV ELECTROPHYSIOLOGY CATHETER SINCE IT IS IN DIRECT CONTACT WITH CARDIAC TISSUE. THE SOUNDSTAR CATHETER IS NOT THE MOST SUSPECTED DEVICE.

  Patient problems: Cardiac Tamponade

  MAUDE report 19122559 ↗
• MalfunctionApr 12, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A DECANAV ELECTROPHYSIOLOGY CATHETER AND DURING THE OPERATION, THE DEVICE COULD NOT BE INSERTED INTO THE PATIENT DUE TO ABNORMAL PROTRUSION OF CATHETER SHAFT. 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 19099639 ↗
• InjuryApr 8, 2024Adverse 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 A PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION PROCEDURE WITH A QDOT MICRO¿ CATHETER AND A DECANAV ELECTROPHYSIOLOGY CATHETER AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED SURGICAL INTERVENTION AND PROLONGED HOSPITALIZATION. CARDIAC TAMPONADE OCCURRED IN A PVC PROCEDURE. THE MOST LIKELY CAUSE IS THAT THE CS CATHETER BROKE THROUGH THE CARDIAC WALL WHEN IT WAS INSERTED VERY DEEPLY. BLEEDING COULD NOT BE STOPPED, AND OPEN CHEST SURGERY WAS PERFORMED. PATIENT REQUIRED PROLONGED HOSPITALIZATION. THE PHYSICIAN'S OPINION ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT IS THERE WAS NO CAUSAL RELATIONSHIP WITH THE BW PRODUCTS. THE PHYSICIAN¿S ASSESSMENT OF THE ADVERSE EVENT IS THAT IT WAS NON-SERIOUS (MODERATE/MINOR). THE EVENT PROBABLY OCCURRED WHEN THE CS CATHETER WAS ADVANCED DEEPER TO PERFORM AN ADDITIONAL ABLATION. NO ABNORMALITIES WERE OBSERVED PRIOR TO OR DURING USE OF THE PRODUCT.

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

  MAUDE report 19060616 ↗