Inquiry™ IBI-81104Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 05414734302975), received between Jun 22, 2018 and Jan 14, 2026 — classified as 2 deaths, 42 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (8 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Aug 24, 2020Terminated

   Steerable diagnostic catheter packages labeled Model IBI-81104, batch 7397352 incorrectly contained Model IBI-87002, batch 7397307. Packages labeled Model IBI-87002, batch 7397307 incorrectly contained Model IBI-81104, batch 7397352.If physicians fail to observe the catheter difference, the intracardiac electrograms will not be representative of the desired signals, could result in procedure delay

   Z-3011-2020 · Root cause: Labeling mix-ups · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 64 reports, in the reporter's own words as published by the FDA.

• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  DURING THE ATRIAL FIBRILLATION AND ATRIAL FLUTTER PROCEDURE WITH PULSED FIELD ABLATION, A PERICARDIAL EFFUSION WAS NOTED, RESULTING IN A PERICARDIOCENTESIS BEING PERFORMED. THE PROCEDURE WAS ABANDONED.

  Patient problems: Cardiac Perforation

  MAUDE report 24066869 ↗
• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, A HEART BLOCK OCCURRED REQUIRING PACING TO RESOLVE. DURING CATHETER PLACEMENT IN THE CORONARY SINUS THE AV NODE WAS BUMPED RESULTING IN TRANSIENT HEART BLOCK. THE HEART BLOCK REMAINED EVIDENT THROUGHOUT PROCEDURE AND RETURNED TO CCU WITH TEMPORARY PACING WIRE BACK UP. THERE ARE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES. THE PATIENT HAS BEEN DISCHARGED.

  Patient problems: Heart Block

  MAUDE report 22910187 ↗
• MalfunctionMay 19, 2025Fracture; Fracture

  DURING THE ATRIAL FIBRILLATION PROCEDURE, AFTER INSERTING THE CATHETER INTO THE PATIENT, DIFFICULTY WAS NOTED WHILE GAINING ACCESS INTO THE RIGHT ATRIUM. THE CATHETER WAS REMOVED FROM THE PATIENT AND A BEND/BREAK WAS NOTED. THE DISTAL TIP WAS FRACTURED BUT WAS STILL ATTACHED TO THE CATHETER. THE CATHETER WAS EXCHANGED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT HEALTH CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22043412 ↗
• MalfunctionApr 21, 2025Material Deformation; Material Deformation

  DURING AN ATRIAL FIBRILLATION PROCEDURE, PIN 10 DID NOT DEFLECT AS EXPECTED AND APPEARED TO HAVE DIFFERENT SPACING. THE CATHETER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21874118 ↗
• InjuryMar 21, 2025Entrapment of Device; Material Twisted/Bent; Entrapment of Device; Material Twisted/Bent

  DURING THE ATRIAL FLUTTER PROCEDURE, WHILE PERFORMING THE SECOND ATTEMPT TO CORONARY SINUS CANNULATION USING NORMAL MANEUVERING, THE CATHETER BENT AND KINKED. A SNARE WAS USED TO REMOVE THE CATHETER THROUGH THE JUGULAR ACCESS. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE DEVICE WAS NOT STUCK ON ANOTHER DEVICE. THE PHYSICIAN THINKS THE KINK WAS CAUSED BY SIGNIFICANT TORQUE DURING MANEUVERING THE CATHETER.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 21664026 ↗
• DeathMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FLUTTER PROCEDURE, THE PATIENT BECAME BRADYCARDIC, WENT INTO CARDIAC ARREST, AND EXPIRED. THE PROCEDURE BEGAN BY POSITIONING THE INQUIRY CATHETER IN THE CORONARY SINUS AND USING A NON-ABBOTT INTRACARDIAC ECHO PROBE TO MAP THE RIGHT ATRIUM. THE MAP AND GEOMETRY WERE COLLECTED WITH A NON-ABBOTT CIRCULAR CATHETER. THE TYPICAL ATRIAL FLUTTER ABLATION WAS PERFORMED WITH A NON-ABBOTT 8MM RF ABLATION CATHETER. AFTER MAPPING AND ABLATION IN THE RIGHT ATRIUM WERE COMPLETED, THE NON-ABBOTT CIRCULAR CATHETER WAS MOVED TO THE LEFT ATRIUM VIA TRANSSEPTAL PUNCTURE USING SWARTZ AND AGILIS SHEATHS AND A BRK NEEDLE. GEOMETRY OF THE LEFT ATRIUM AND A VOLTAGE MAP WERE COLLECTED AND SHOWED AN ELECTRICAL SIGNAL IN THE PULMONARY VEINS. ISOLATION OF THE PULMONARY VEINS BEGAN WITH A NON-ABBOTT (FARAPULSE, BOSTON SCIENTIFIC) CATHETER AND NON-ABBOTT (BOSTON SCIENTIFIC) EQUIPMENT AND TECHNICAL SUPPORT. IMMEDIATELY AFTER ABLATION OF THE PULMONARY VEINS, A NEW MAP OF THE LEFT ATRIUM WAS COLLECTED USING THE NON-ABBOTT CIRCULAR CATHETER TO CHECK WHETHER THE VEINS WERE ISOLATED. AT THAT MOMENT, AFTER THE GEOMETRY COLLECTION BEGAN ON THE POSTERIOR WALL OF THE LEFT ATRIUM, THE PATIENT BECAME BRADYC

  Patient problems: Arrhythmia; Cardiac Arrest

  MAUDE report 21528909 ↗
• InjuryFeb 18, 2025Device Contamination with Body Fluid; Device Contamination with Body Fluid

  AT THE END OF A PERSISTENT ATRIAL FIBRILLATION ABLATION PROCEDURE, THE PHYSICIAN NOTED WHAT APPEARED TO BE THROMBUS ON THE CORONARY SINUS CATHETER IN THE RIGHT ATRIUM. NOTHING WAS SEEN ON THE CATHETER WHEN IT WAS REMOVED FROM THE PATIENT. THE PHYSICIAN DID NOT ALLEGE THIS WAS DUE TO ANY DEFICIENCY OF THE CATHETER. THE PATIENT WAS STABLE AND AWARE AFTER THE PROCEDURE, THERE WERE NO COMPLICATIONS. IT IS UNKNOWN IF ANY IMAGING WAS DONE PRIOR TO THE PROCEDURE TO RULE OUT THROMBUS AND IT IS UNKNOWN IF THE PATIENT HAD ANY PREDISPOSITION FOR THROMBUS. NO THROMBUS WAS NOTED ON ICE IN THE RIGHT ATRIUM AT THE BEGINNING OF THE PROCEDURE. THERE WERE NO PERFORMANCE ISSUES WITH THE CATHETER.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21402937 ↗
• MalfunctionOct 10, 2024Fracture; Fracture

  AFTER THE END OF THE AVNRT CASE AND AFTER THE DOCTOR WITHDREW THE CATHETER FROM THE PATIENT, HE OBSERVED A CUT ON THE SHAFT OF THE CATHETER. THE PHYSICIAN IS CONCERNED A PIECE OF MATERIAL WAS LEFT IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 20416849 ↗
• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED IN THE RIGHT ATRIUM REQUIRING A PERICARDIOCENTESIS. FOLLOWING TRANSSEPTAL PUNCTURE, PRIOR TO INSERTING THE VOLT CATHETER THE PERICARDIAL EFFUSION WAS OBSERVED WITH THE ICE CATHETER. PROTAMINE WAS ADMINISTERED, AND WHEN PERFORMING THE PERICARDIOCENTESIS, THE BLOOD WAS NOTED TO BE VENOUS IN NATURE. THE PATIENT IS STABLE. IT IS UNKNOWN WHAT CAUSED THE PERICARDIAL EFFUSION; HOWEVER, IT COULD HAVE BEEN CAUSED BY MANEUVERING THE CATHETER IN THE CORONARY SINUS OR BY MANEUVERING THE INTRODUCER FOR TRANSEPTAL PUNCTURE. THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 20354558 ↗
• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REFERENCE: 3005334138-2024-00381. DURING THE ATRIAL FIBRILLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED WHICH REQUIRED A PERICARDIOCENTESIS TO STABILIZE THE PATIENT. AFTER THE TRANSSEPTAL PUNCTURE WITH THE SWARTZ BRAIDED SL0 INTRODUCER, THE DEVICE WAS EXCHANGED FOR AN AGILIS 13 FR INTRODUCER TO PRE-MAP WITH AN ADVISOR HD GRID CATHETER. THE AGILIS WAS LEFT SIDE. A PERICARDIAL EFFUSION WAS SEEN ON ICE. THE PROCEDURE WAS STOPPED AND A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT, BLOOD WAS DRAINED FROM THE RIGHT ATRIUM. THE PHYSICIAN STATES THE EFFUSION LIKELY OCCURRED WHILE REPOSITIONING THE CORONARY SINUS CATHETER OR WHILE MOVING THE SWARTZ BRAIDED SL0 INTRODUCER. THERE WERE NO REPORTED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 20229257 ↗
• InjuryAug 26, 2024Entrapment of Device; Entrapment of Device

  AT THE END OF AN ATRIAL FIBRILLATION PROCEDURE, IT WAS NOT POSSIBLE TO RETRACT THE ADVISOR HD GRID AND INQUIRY DECAPOLAR CATHETER FROM THE FEMORAL VEIN. AN XRAY IMAGE INDICATED THE INQUIRY DECAPOLAR CATHETER WAS WRAPPED AROUND ADVISOR HD GRID CATHETER. A VASCULAR PHYSICIAN ASSISTED WITH REMOVAL OF THE CATHETERS BY CUTTING THE ENTRY POINT SO THAT IT WAS BIGGER. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: Foreign Body In Patient

  MAUDE report 20065183 ↗
• InjuryJul 24, 2024Entrapment of Device; Fracture; Difficult to Remove; Material Twisted/Bent; Entrapment of Device; Fracture; Difficult to Remove; Material Twisted/Bent

  DURING THE PROCEDURE, WHEN ADVANCING THE CATHETER, IT WENT INTO A SIDE BRANCH OF THE FEMORAL VEIN. WHEN ATTEMPTING TO RETRACT THE CATHETER, ALL TORQUE ABILITY WAS LOST AND FLOUROSCOPY REVEALED THE CATHETER WAS KINKED AND THE OUTER CASING WAS CRACKED. MULTIPLE ATTEMPTS WERE UNSUCCESSFUL TO REMOVE THE DEVICE AND VASCULAR SURGERY CAME IN WITH A SNARE TO REMOVE THE CATHETER. THE PATIENT WAS AND IS IN STABLE CONDITION THE ENTIRE TIME. THE CASE WAS CANCELLED DUE TO THIS COMPLICATION.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19820087 ↗
• InjuryJul 1, 2024Difficult to Insert; Difficult to Insert

  FOUR HOURS AFTER AN ATRIAL FIBRILLATION PROCEDURE, A CARDIAC TAMPONADE WAS NOTED. DURING THE PROCEDURE, THERE WAS NOTED DIFFICULTY IN CANNULATING THE CORONARY SINUS WITH THE INQUIRY DIAGNOSTIC CATHETER, AND IT IS ALLEGED TO HAVE CAUSED THE CARDIAC TAMPONADE. THE PATIENT REMAINS STABLE.

  Patient problems: Cardiac Perforation

  MAUDE report 19643830 ↗
• InjuryMar 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT THE END OF A VENTRICULAR TACHYCARDIA ABLATION, THERE WAS A PERICARDIAL EFFUSION IN THE RIGHT VENTRICLE. IT IS ALLEGED THAT THE CAUSE OF THE PERFORATION WAS THE INQUIRY STEERABLE DIAGNOSTIC CATHETER. TRANSSEPTAL PUNCTURE WAS PERFORMED AND THEN MAPPING OF THE VENTRICULAR TACHYCARDIA WAS COMPLETED IN THE LEFT VENTRICLE. ONCE ABLATION WAS COMPLETED ANOTHER VENTRICULAR TACHYCARDIA WAS THEN MAPPED. IT WAS ATTEMPTED TO STIMULATE THE RIGHT VENTRICLE AND PUSH THE INQUIRY STEERABLE DIAGNOSTIC CATHETER AT THE APEX, BUT THERE WAS NOT A GOOD LOCALIZATION. THE INQUIRY STEERABLE DIAGNOSTIC CATHETER WAS REPOSITIONED AND THEN IT WAS NOTED ON THE SCREEN OF THE X-RAY THAT THE INQUIRY STEERABLE DIAGNOSTIC CATHETER WAS OUT OF THE SHADOW OF THE HEART. THE PATIENT WAS EXPERIENCING PAINFUL, TACHYCARDIA, AND LOW BLOOD PRESSURE. THE PERICARDIAL EFFUSION WAS CONFIRMED BY AN ECHOCARDIOGRAM AT THE APEX OF THE RIGHT VENTRICLE. A PERICARDIOCENTESIS WAS PERFORMED, 2 UNITS OF PACKED RED BLOOD CELLS, INOTROPES MEDICATIONS, AND PROTAMINE WAS ADMINISTERED TO STABILIZE THE PATIENT. THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH THE INQUIRY STEERABLE DIAGNOSTIC CATHETER.

  Patient problems: Cardiac Perforation

  MAUDE report 19003684 ↗
• MalfunctionJun 8, 2023Difficult to Remove; Difficult to Remove

  DURING THE ATRIAL FIBRILLATION PROCEDURE, WHEN THE CORONARY SINUS CATHETER WAS INSERTED AND THE CATHETER WAS PLACED IN A SIDE BRANCH OF THE LATERAL FEMORAL VEIN, IT WAS NOTED THAT THE CATHETER BECAME STUCK. THE PROCEDURE CONTINUED WITH THE CATHETER STUCK IN THE VEIN BUT AN ADDITIONAL PUNCTURE IN THE FEMORAL VEIN WAS MADE TO INSERT A NON-ABBOTT DEVICE (QUADRIPOLAR XTREM). THE CATHETER WAS ABLE TO BE REMOVED THROUGH MANIPULATION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17093090 ↗
• InjuryMay 16, 2023Difficult to Insert; Difficult to Insert

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A PERITONEAL EFFUSION OCCURRED REQUIRING SURGERY. THE PATIENT'S BLOOD PRESSURE DROPPED AND AN ULTRASOUND REVEALED A PERITONEAL EFFUSION. THE EFFUSION WAS DUE TO DIFFICULTIES DURING INSERTION OF THE CORONARY SINUS CATHETER. THIS LED TO TWO PERFORATIONS INTO THE JUNCTION BETWEEN THE FEMORAL AND ILIAC VEINS. THE PATIENT WAS TRANSFERRED TO SURGERY WHERE 2 HOLES WERE SUTURED TO STABILIZE THE PATIENT.

  Patient problems: Perforation; Retroperitoneal Hemorrhage

  MAUDE report 16939867 ↗
• InjuryMay 5, 2023Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  DURING A VENTRICULAR TACHYCARDIA (VT) PROCEDURE, THE CATHETER COULD NOT BE REMOVED AND AN ADDITIONAL PUNCTURE SITE WAS NEEDED. UPON INSERTION INTO THE RIGHT ATRIUM, THE CATHETER KINKED WHILE MANEUVERING AND COULD NOT BE STRAIGHTENED. AN ATTEMPT TO EXTRACT THE CATHETER WAS NOT POSSIBLE, AS IT DID NOT GO THROUGH THE SHEATH. THE DECISION WAS MADE TO LEAVE THE CATHETER IN THE VEIN AND TO DO AN ADDITIONAL PUNCTURE TO PLACE ANOTHER INQUIRY CATHETER THROUGH A NEW SHEATH. THE FIRST CATHETER WAS LEFT IN THE VEINS THROUGHOUT THE PROCEDURE. A SECOND CATHETER WAS PLACED VIA AN ADDITIONAL PUNCTURE WITHOUT PROBLEMS. FOLLOWING THE PROCEDURE, ALL CATHETERS WERE REMOVED WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16876850 ↗
• InjuryMar 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A VENTRICULAR EXTRASYSTOLE ABLATION PROCEDURE, A PERICARDIAL EFFUSION WAS NOTED. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. WHEN THE INQUIRY STEERABLE DIAGNOSTIC CATHETER WAS POSITIONED IN THE CORONARY SINUS, A CHANGE WAS FELT IN THE PATIENT'S HEART AREA BY X-RAY IMAGES. A TRANSTHORACIC ECHO WAS PERFORMED, NO PERICARDIAL EFFUSION WAS NOTED AND THE PROCEDURE CONTINUED. AT THE END OF THE PROCEDURE, THE PATIENT'S BLOOD PRESSURE BEGAN TO DROP AND A NEW TRANSTHORACIC ECHO WAS PERFORMED WHICH CONFIRMED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED. AFTER 30 MINUTES OF CONTROL, THE PATIENT LEFT THE ROOM STABLE. THERE WERE NO PERFORMANCE ISSUES WITH THE ABBOTT MATERIALS USED DURING THE PROCEDURE. THE PHYSICIAN BELIEVED THAT POSITIONING THE DIAGNOSTIC CATHETER IN THE CORONARY SINUS CAUSED THE PERFORATION.

  Patient problems: Cardiac Perforation

  MAUDE report 16632241 ↗
• MalfunctionJan 19, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THE PHYSICIAN HAD DIFFICULTY TRYING TO ACCESS THE CS WITH THE CATHETER RESULTING IN A DELAY OF THE PROCEDURE. THE CATHETER WAS NOTICED TO BE DEFORMED (S SHAPE) WHEN THE CATHETER WAS TAKEN OUT OF THE BODY FOR CHECKING. THE CATHETER WAS REPLACED WITH ANOTHER IBI-81104 AND HAD THE SAME ISSUE. THE CATHETERS WERE THEN REPLACED WITH A LIVEWIRE CATHETER AND THE ISSUE WAS RESOLVED. THE CASE PROCEEDED AS PER NORMAL WITHOUT ANY PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16200667 ↗
• MalfunctionJan 19, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THE PHYSICIAN HAD DIFFICULTY TRYING TO ACCESS THE CS WITH THE CATHETER RESULTING IN A DELAY OF THE PROCEDURE. THE CATHETER WAS NOTICED TO BE DEFORMED (S SHAPE) WHEN THE CATHETER WAS TAKEN OUT OF THE BODY FOR CHECKING. THE CATHETER WAS REPLACED WITH ANOTHER IBI-81104 AND HAD THE SAME ISSUE. THE CATHETERS WERE THEN REPLACED WITH A LIVEWIRE CATHETER AND THE ISSUE WAS RESOLVED. THE CASE PROCEEDED AS PER NORMAL WITHOUT ANY PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16200665 ↗
• MalfunctionMay 28, 2022Material Deformation; Material Deformation

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING A DISPLACED ELECTRODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14531770 ↗
• MalfunctionApr 21, 2022Fracture; Fracture

  DURING A SUPRAVENTRICULAR TACHYCARDIA / ATRIOVENTRICULAR NODAL REENTRANT PROCEDURE, FLUOROSCOPY REVEALED A FRACTURE IN THE CATHETER DURING ADVANCEMENT INTO THE CORONARY SINUS. THE DEVICE WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14166948 ↗
• MalfunctionSep 9, 2021Difficult to Insert; Activation, Positioning or Separation Problem; Difficult to Insert; Activation, Positioning or Separation Problem

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THE CATHETER DID NOT KEEP ITS CURVE AND A DELAY OCCURRED. A NEW CATHETER WAS OPENED AND MANIPULATED, HOWEVER THE PHYSICIAN PREFERRED THE FEEL OF THE FIRST CATHETER. THEREFORE, THE FIRST CATHETER INSERTED AGAIN AND WAS NOT ABLE TO ADVANCE INTO THE CORONARY SINUS. A LIVEWIRE CATHETER WAS THEN USED TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12447249 ↗
• InjuryJun 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING AN ATRIAL FIBRILLATION PROCEDURE, WHILE STILL IN THE PROCEDURE ROOM, A CORONARY SINUS PERFORATION OCCURRED. FOLLOWING RF ABLATION, AN ULTRASOUND REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED AND AFTER THE DRAIN WAS PLACED THE EFFUSION DID NOT TOP. AN EMERGENCY STERNOTOMY WAS PERFORMED AND THE EFFUSION WAS RESOLVED. IT WAS NOTED DURING THE STERNOTOMY, WHILE PERFORMING AN ULTRASOUND, THAT THE PATIENT'S CORONARY SINUS HAD BEEN PERFORATED DISTALLY. THE PATIENT IS CURRENTLY IN STABLE CONDITION. THE DECAPOLAR INQUIRY CATHETER HAD BEEN PLACED INTO THE CORONARY SINUS WITHOUT DIFFICULTY. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Great Vessel Perforation

  MAUDE report 12061429 ↗
• InjuryJun 10, 2021Difficult to Remove; Difficult to Remove

  DURING A FOCAL ATRIAL TACHYCARDIA ABLATION PROCEDURE, THE CATHETER WAS NOTED TO BECOME STUCK AT THE CORONARY SINUS OSTIUM AND WAS THOUGHT TO HAVE REMOVED A PIECE OF HEART TISSUE WHEN FINALLY REMOVING THE CATHETER. THE CATHETER WAS ABLE TO BE REMOVED WITHOUT ANY INTERVENTION. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS ABLE TO BE COMPLETED. THE PATIENT EXPERIENCED CHEST PAIN FOLLOWING THE PROCEDURE, BUT WAS NOTED TO BE STABLE. NO PERICARDIAL EFFUSION WAS NOTED ON ECHOCARDIOGRAM.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11979057 ↗