SmartAblateTM System Irrigation Pump M490008Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 04260166371093), received between Nov 20, 2018 and Jul 11, 2023 — classified as 17 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (11 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryJul 11, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM AND A SMARTABLATE¿ SYSTEM IRRIGATION PUMP (US) AND THE PATIENT EXPERIENCED AN AIR EMBOLISM AND MEDICAL INTERVENTION WAS REQUIRED. IT WAS REPORTED THAT WHILE DOING THE PULMONARY VEIN ISOLATION AND TOWARD THE END OF THE PROCEDURE, THE PHYSICIAN NOTICED BUBBLES INSIDE THE AORTA. THEY REPORTED THAT THE PATIENT'S BLOOD PRESSURE DROPPED AND HEART RATE SLOWED. THE BUBBLES WERE CONFIRMED WITH INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE PHYSICIAN PERFORMED HEART CATH MANEUVERS TO DETERMINE WHERE THE BUBBLES ORIGINATED FROM. THE PHYSICIAN WAS UNABLE TO DETERMINE WHERE THE BUBBLES ORIGINATED FROM DURING THE PROCEDURE. THE PROCEDURE WAS ABORTED. THEY WERE IN THE TESTING PHASE AND THAT THE THERAPEUTIC PORTION OF THE PROCEDURE WAS COMPLETED. THE PATIENT WOKE UP, WAS BREATHING FINE, AND PASSED TESTS FROM THE CERTIFIED REGISTERED NURSE ANESTHETIST (CRNA) AND NURSES. THE PATIENT WAS SENT TO THE EMERGENCY DEPARTMENT TO BE EVALUATED PER PROTOCOL. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. POST-PROCEDURE THE PHYSICIAN DETERMINED THAT THE BUBBLES HAD COME FROM THE PRES

  Patient problems: Air Embolism

  MAUDE report 17303454 ↗
• InjuryMay 1, 2023No Audible Alarm; Decreased Pump Speed; Patient Device Interaction Problem; No Audible Alarm; Decreased Pump Speed; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND A SMARTABLATE¿ SYSTEM IRRIGATION PUMP (US) AND THE PATIENT EXPERIENCED A CEREBROVASCULAR ACCIDENT. IT WAS REPORTED THAT THE ABLATION DEVICE FAILED TO ALARM LOW FLUID LEVEL. WHEN AIR WAS VISUALIZED IN LINE BEHIND LIQUID, THE LINE DID SHUT DOWN WHEN THE AIR SENSED. PATIENT SUFFERED POST OPERATIVE STROKE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION AND CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Stroke/CVA

  MAUDE report 16844349 ↗
• InjuryMar 2, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED BY THE CLINICAL ACCOUNT SPECIALIST THAT DURING AN ABLATION PROCEDURE THEY RECEIVED A BUBBLE ERROR ALERT TRIGGERED BY THE SMARTABLATE PUMP. THEY WENT TO TROUBLESHOOT THE ISSUE AND NOTICED "THE BAG HAD RUN DRY" AND SO THEY "HUNG A NEW BAG". UPON TRYING TO FLUSH THE NEW BAG THEY LEFT THE WRONG LINE OPEN AND WHEN THEY TRIED TO FLUSH THROUGH THEY FLUSHED THROUGH THE LINE STILL CONNECTED INSIDE THE PATIENT CAUSING AN EMBOLISM. THE INJURY WAS CONFIRMED VIA EKG MONITORING AND THE STSF CATHETER SHOWED "ST ELEVATION" THROUGH THE COOLFLOW. THERE WAS NO MEDICAL INTERVENTION DIRECTLY PROVIDED HOWEVER THE PHYSICIAN OBSERVED THE PATIENT UNTIL THE EMBOLISM RESOLVED AND THE PROCEDURE CONTINUED. THE PATIENT IS NOW STABLE. THE STSF CATHETER IS AVAILABLE FOR RETURN AND THE CALLER WAS ADVISED TO EXPECT A RETURN KIT.

  Patient problems: Air Embolism

  MAUDE report 16474203 ↗
• InjuryNov 23, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM AND A SMARTABLATE¿ SYSTEM IRRIGATION PUMP (US) AND THE PATIENT SUFFERED ST ELEVATION DUE TO AN AIR EMBOLISM. IT WAS REPORTED THAT DURING AN AFIB CASE, THE PATIENT SUFFERED ST ELEVATION. THE BWI REPRESENTATIVE REPORTED AFTER THE FIRST ABLATION LESION, THE PATIENT SUFFERED ST ELEVATION FOR ABOUT 6 ½ MINS. IT WAS THOUGHT TO BE AN AIR EMBOLISM THAT WAS INTRODUCED. NO MEDICAL INTERVENTION WAS PROVIDED, AND THE ISSUE RESOLVED ON ITS OWN. THE CASE WAS CONTINUED AND COMPLETED WITH NO OTHER ISSUES. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. IT WAS ALSO NOTED THAT WHEN THE ABLATION CATHETER WAS REMOVED FROM THE VIZIGO SHEATH, THEY DISCOVERED SALINE FLUID LEAKING FROM THE HUB. ADDITIONAL INFORMATION WAS INDICATING THERE WAS NO ABILITY TO SAY FOR CERTAIN IF AN AIR EMBOLISM OCCURRED, HOWEVER, THE PHYSICIAN FELT THAT AN AIR EMBOLISM WAS THE CAUSE FOR THE INTERMITTENT ST ELEVATION. PHYSICIAN FELT THE EVENT COULD HAVE BEEN CAUSED BY AIR ENTERING THE HEMOSTATIC VALVE OF THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM.

  Patient problems: Air Embolism

  MAUDE report 15850883 ↗
• InjuryOct 7, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER AND SMARTABLATE¿ SYSTEM IRRIGATION PUMP (US) AD THE PATIENT SUFFERED ASYSTOLE, AIR EMBOLISM AND CARDIAC ARREST. UPON ABLATION THERE WAS A HIGH TEMPERATURE ALARM ON THE GENERATOR. THE PATIENT WENT INTO ASYSTOLE AND ON FLUOROSCOPY THE HEART WAS AT STANDSTILL. PACING WAS THEN STARTED IN THE VENTRICLE AND DID CAPTURE BUT THE HEART WAS STILL AT STANDSTILL. CARDIOPULMONARY RESUSCITATION (CPR) WAS THEN STARTED AND THE PATIENT WAS GIVEN EMERGENCY MEDICATION. THE PATIENT RECOVERED BUT THE BWI REPRESENTATIVE WAS NOT IN THE ROOM AT THAT TIME. IT WAS ALSO REPORTED THERE WAS NO ULTRASOUND IMAGE ON THE CARTO AND ULTRA SOUND (US) UNIT. THERE WAS ALSO AN UNKNOWN ERROR. THE BWI REPRESENTATIVE RESEATED THE US CABLES AND CATHETERS. THE SOUNDSTAR CATHETER AND ECO-CABLE WERE REPLACED, AND THAT ISSUE RESOLVED BUT THE IMAGE WAS PURPLE. THROUGH TROUBLESHOOTING IT WAS DETERMINED THAT THE CABLE NEEDS REPLACEMENT. THEN THE ABLATION IRRIGATION BAG WAS DRY AND A BUBBLE ALARM OCCURRED. THEY FLUSHED THE LINES AND WENT TO LOW FLOW. THE ADVERSE EVENT WAS DISCOVER

  Patient problems: Air Embolism; Asystole; Cardiac Arrest

  MAUDE report 15567918 ↗
• InjuryAug 10, 2022Failure to Sense; Patient Device Interaction Problem; Failure to Sense; Patient Device Interaction Problem

  IT WAS REPORTED THAT A FEMALE PATIENT IN HER 50¿S UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) CRYOABLATION PROCEDURE WITH A SMARTABLATE¿ SYSTEM IRRIGATION PUMP (US) AND THE PATIENT SUFFERED AIR EMBOLISM AND ELECTROCARDIOGRAM ST SEGMENT ELEVATION. THE PHYSICIAN SUSPECTED THAT BUBBLES WERE PRESENT BUT THAT THE SMARTABLATE¿ SYSTEM IRRIGATION PUMP (US)DID NOT DISPLAY A BUBBLE ERROR. DURING THE PAROXYSMAL AFIB CASE, A BIOMEDICAL ENGINEER, THAT THE CATH LAB TECH NOTICED MICROBUBBLES RUNNING THROUGH THE TUBING SET AND THEN INTO THE PATIENT. IT IS UNKNOWN IF THE TUBING SET WAS CONNECTED TO A CATHETER OR SHEATH. A SUSPECTED AIR EMBOLISM OCCURRED AFTER THE MEDTRONIC FLEXCATH SHEATH WAS INSERTED IN THE LEFT ATRIUM. THE BWI REPRESENTATIVE REPORTED THAT THERE WAS ST ELEVATION ON THE EKG AND THAT THE PATIENT'S BLOOD PRESSURE HAD DROPPED. WHEN THEY MOVED THE MEDTRONIC FLEXCATH SHEATH BACK TO THE RIGHT ATRIUM, THE BLOOD PRESSURE ISSUE AND ST ELEVATION ISSUE WERE BOTH RESOLVED. THE BWI REPRESENTATIVE REPORTED THAT AN AIR EMBOLISM WAS NOT CONFIRMED BY ICE AND THE PROCEDURE WAS CONTINUED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AS THE "PATIENT WAS ABLE TO PUSH THEM OUT". THERE WERE N

  Patient problems: Air Embolism; Ischemic Heart Disease

  MAUDE report 15196692 ↗
• InjuryDec 29, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH A PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE AND A SMARTABLATE¿ SYSTEM IRRIGATION PUMP (US) AND THE PATIENT SUFFERED A STROKE. IT WAS REPORTED THAT AT THE END OF THE PREMATURE VENTRICULAR CONTRACTION ABLATION, THE PATIENT SUFFERED A STROKE. THE ABLATION HAD BEEN PERFORMED IN THE RIGHT VENTRICULAR OUTFLOW TRACTS (RVOT) AND AORTIC ROOT USING A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. AT THE END, THE PHYSICIAN NOTICED AIR ENTERING THE SYRINGE DURING ASPIRATION WITH THE PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE. THE PATIENT COMPLAINED OF BODY ACHES. THE REPORTER WAS UNAWARE OF ANY OTHER PATIENT SYMPTOMS. FURTHER NEUROLOGIC TESTING REVEALED THAT THE PATIENT HAD A STROKE. THE PATIENT WAS CONSCIENCE DURING AND AFTER THE PROCEDURE AND HAD BEEN TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). FURTHER PATIENT STATUS WAS UNKNOWN. THE PHYSICIAN WAS UNSURE HOW OR WHEN THE AIR EMBOLUS AND STROKE OCCURRED, POSSIBLY FROM ONE OF THE PRESSURIZED SALINE BAGS USED DURING ABLATION. THE PHYSICIAN DID NOT INDICATE THAT THEY BELIEVED BWI PRODUCTS CONTRIBUTED TO THE P

  Patient problems: Air Embolism; Stroke/CVA

  MAUDE report 13114712 ↗
• InjurySep 21, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AN (B)(6) FEMALE WITH HISTORY OF PAROXYSMAL AFIB, UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A SMARTABLATE¿ SYSTEM IRRIGATION PUMP (US) AND THE PATIENT SUFFERED AIR EMBOLISM CAUSING BRADYCARDIA, ELECTROCARDIOGRAM ST SEGMENT ELEVATION AND REQUIRING PROLONGED HOSPITALIZATION. THE PATIENT SUFFERED AN AIR EMBOLISM. IT WAS REPORTED THE ACCOUNT DID NOT HAVE ANY OF THE 1000CC BAGS OF NORMAL SALINE FOR USE WITH THE SMARTABLATE PUMP AND A 500CC BAG WAS USED. THE SETTINGS WERE NOT ADJUSTED FOR THE SMALLER BAG AND FLUID RAN OUT IN THE MIDDLE OF THE PROCEDURE AND NO WARNING WAS ACTIVATED DUE TO THE SETTINGS. THEY NOTICED THE BAG WAS EMPTY AND AIR WAS SUSPECTED OF GETTING INTO THE PATIENT. THE PATIENT EXPERIENCED VENTRICULAR BRADYCARDIA AND ST ELEVATIONS. BOTH RESOLVED AND IT WAS DECIDED TO CONTINUE THE PROCEDURE. AT THE END OF THE PROCEDURE THE PATIENT WAS NOT WAKING UP. THEY ARE MONITORING THE PATIENT AND NO OTHER INTERVENTION IS PLANNED AT THIS TIME. ADDITIONAL INFORMATION WAS LATER RECEIVED INDICATING THAT MEDICAL INTERVENTION PROVIDED WAS VENTRICULAR PACING AND MEDICATION FOR HEMODYNAMIC SUPPORT AND A COMPUTED TOMOGRAPHY (CT) BRAIN SCAN AND ECG. PA

  Patient problems: Air Embolism; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bradycardia

  MAUDE report 12510840 ↗
• InjurySep 2, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO VIZIGO" 8.5F BI-DIRECTIONAL GUIDING SHEATH  SMALL AND A SMARTABLATE" SYSTEM IRRIGATION PUMP (US) AND THE PATIENT SUFFERED AIR EMBOLISM AND ELECTROCARDIOGRAM ST SEGMENT ELEVATION REQUIRING MEDICAL INTERVENTION AND PROLONGED HOSPITALIZATION. DURING AN AFIB CASE, AN AIR EMBOLISM WAS NOTICED AFTER THE THERMOCOOL¿ SMART TOUCH¿ SF BI-DIRECTIONAL NAVIGATION CATHETER WAS FINISHED ABLATING, AND "EVERYTHING" WAS PULLED TO THE "RIGHT SIDE". CALLER REPORTED THE AIR EMBOLISM WAS DISCOVERED WHEN THE PATIENTS PRESSURE/ST ELEVATION DROPPED. THE AIR EMBOLISM WAS CONFIRMED BY ECO. THEY CONFIRMED THAT AIR WAS IN THE LEFT SIDE OF THE VENTRICULAR. MEDICAL INTERVENTION PROVIDED WAS MEDICATION WAS ADMINISTERED TO THE PATIENT AND THE PATIENTS HEAD WAS LOWERED AND THE FEET WERE ELEVATED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. ADDITIONAL INFORMATION RECEIVED INDICATED THE PHYSICIAN WAS UNSURE WHAT THE EXACT CAUSE OF THE EVENT SINCE IT WAS DISCOVERED AT THE END OF THE CASE. HE BELIEVED IT COULD HAVE BEEN THE SHEATH AND WENT WITH ANOTHER OPTION FOR HIS NEXT CASE TO RULE IT OUT.

  Patient problems: Air Embolism; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12411926 ↗
• InjuryAug 31, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE AND A SMARTABLATE¿ SYSTEM IRRIGATION PUMP (US) AND THE PATIENT SUFFERED AIR EMBOLISM AND ST SEGMENT ELEVATION REQUIRING INTERVENTIONAL CARDIOLOGY INTERVENTION. IT WAS REPORTED THAT DURING THE AFIB CASE, DURING USE OF BIOSENSE WEBSTER PRODUCTS, THE NURSE STAFF WENT TO FAST FLUSH ON THE SMARTABLATE¿ SYSTEM IRRIGATION PUMP (US) AND SHE DID NOT NOTICE THAT THERE WAS AIR IN THE BAG AND FLUSHED INTO THE PATIENT. THE PATIENT HAD ST ELEVATION. THEY PUT ON 100 PERCENT OXYGEN AND INTERVENTIONAL CARDIOLOGY WAS ABLE TO GET THE AIR OUT THE RIGHT CORONARY. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS THAT IT WAS USER ERROR. PATIENT OUTCOME FROM THE ADVERSE EVENT IS REPORTED TO BE IMPROVED. THE PATIENT DID NOT HAVE AN EXTENDED HOSPITALIZATION.

  Patient problems: Air Embolism; Ischemic Heart Disease

  MAUDE report 12393837 ↗
• InjuryMay 11, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A SMARTABLATE¿ SYSTEM IRRIGATION PUMP (US) AND DEVELOPED ST SEGMENT ELEVATION. DURING THE PROCEDURE, THE TEMPERATURE VALUE FROM THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER (30501064M) WAS NOT DISPLAYING ON THE SMARTABLATE® GENERATOR AND AN INVALID TEMPERATURE ERROR WAS DISPLAYED WHEN TRYING TO GO INTO ABLATION. THE CABLE WAS REPLACED WITHOUT RESOLUTION. THE CATHETER WAS REPLACED, AND THE ISSUE RESOLVED. THE CASE CONTINUED. IT WAS ALSO REPORTED THAT WHILE USING THE REPLACEMENT THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER (30514020M), ERROR# 100 - EEPROM DATA SERVICE - DISPLAYED ON THE CARTO® 3 SYSTEM. THE CATHETER WAS REPLACED, AND THE ISSUE RESOLVED. THE CASE CONTINUED. THE ISSUE WAS CATHETER RELATED. THE CARTO® 3 SYSTEM IS OPERATING PER SPECS AND IS NOT RESPONSIBLE FOR THE PRODUCT ISSUE. AFTER THE CATHETER WAS REPLACED, ST SEGMENT ELEVATION WAS NOTED ON THE ELECTROCARDIOGRAM (ECG) SIGNALS. A CORONARY INTERVENTIONIST WAS CALLED IN AND AN ARTERIOGRAM WAS PERFORMED. IT WAS DETERMINED THE CORONARIES WERE CLEAN, SO THE BLOCKAGE HAD RESOLVED

  Patient problems: Air Embolism

  MAUDE report 11807327 ↗
• InjuryDec 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT A REPEAT CARDIAC ABLATION PROCEDURE FOR ATRIAL FIBRILLATION (AFIB) WITH SMARTABLATE¿ SYSTEM IRRIGATION PUMP (US) AND SUFFERED AIR EMBOLISM REQUIRING SURGICAL INTERVENTION. WHILE ABLATING ON THE RIDGE BETWEEN THE LEFT ATRIAL APPENDAGE AND THE LEFT SUPERIOR VEIN FOR ABOUT 2 MINUTES (POINT BY POINT ABLATION) ANESTHESIA AND THE PHYSICIAN NOTICED THAT THERE WAS A DROP IN BLOOD PRESSURE AND ST-ELEVATIONS. AN INTERVENTIONAL CARDIOLOGIST WAS PAGED FOR A CONSULT AND A CARDIAC CATHETERIZATION WAS PERFORMED. THE CARDIAC CATHETERIZATION REVEALED AN AIR EMBOLISM IN THE RIGHT CORONARY ARTERY (RCA). THE INTERVENTIONALIST CARDIOLOGIST WAS ABLE TO GET A WIRE THROUGH AND RESOLVE THE AIR EMBOLISM. THE ABLATION PROCEDURE WAS ABORTED AT THAT TIME. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE AND WAS ADMITTED TO THE INTENSIVE CARE UNIT FOR OVERNIGHT OBSERVATION. THE PHYSICIAN DOES NOT KNOW IF IT MIGHT HAVE BEEN CAUSED BY EXCHANGING MULTIPLE CATHETERS THROUGH THE SAME SHEATH OR NOT FLUSHING ONE OF THE CATHETERS ENOUGH. THEY BELIEVE IT COULD BE DUE TO A SINGLE TRANSSEPTAL APPROACH AND THE EXCHANGE OF MULTIPLE CATHETERS (DUE TO TECHNICAL DIFFICULTIES WITH VI

  Patient problems: Air Embolism

  MAUDE report 10933034 ↗
• InjuryNov 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT CARDIAC ABLATION PROCEDURE FOR ATRIAL FIBRILLATION (AFIB) WITH A SMARTABLATE¿ SYSTEM IRRIGATION PUMP (US) AND SUFFERED AIR EMBOLISM REQUIRING MEDICATION. IT WAS REPORTED THAT FOLLOWING AN ATRIAL FIBRILLATION CASE, ST-SEGMENT ELEVATION WAS NOTICED. THE CALLER REPORTED THAT AFTER COMPLETING AN ABLATION, THE PHYSICIAN PERFORMED A "FAST FLUSH" THROUGH THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER, ALONG THE LEFT POSTERIOR WALL, TO COOL DOWN THE TISSUE. THE CALLER REPORTED THAT THEY HAD ADVISED THE PHYSICIAN OF OFF-LABEL USE FOR THE FAST FLUSH SETTING, AND THE PHYSICIAN HAD PROCEEDED WITH THE FAST FLUSH. THE FLOW RATE OF THE FAST FLUSH WAS UNKNOWN BY THE CALLER. CALLER REPORTED THAT WHILE ACTIVELY PACING, ST ELEVATION IN THE PATIENT WAS NOTICED, AND THERE WAS A DROP IN BLOOD PRESSURE ON THE PATIENT AFTERWARDS. THE CALLER THEN REPORTED THAT WHILE VISUALIZING ON THE ULTRASOUND SYSTEM WITH THE ICE CATHETER, IT WAS CONFIRMED THAT THERE WERE SMALL AIR BUBBLES INSIDE THE PATIENT'S AORTA. WHILE VISUALIZING VIA ULTRASOUND, IT WAS ALSO CONFIRMED THAT NO EFFUSION WERE PRESENT. CALLER REPORTED THAT THE MEDICAL INTERVENTION PROVIDED WAS

  Patient problems: Air Embolism

  MAUDE report 10821045 ↗
• InjuryJul 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION WITH A PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE AND A SMARTABLATE¿ SYSTEM IRRIGATION PUMP (US) AND SUFFERED AIR EMBOLISM. WHILE MAPPING THE RIGHT SUPERIOR PULMONARY VEIN (RSPV) WITH THE THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER, A POSSIBLE CALCIFICATION OR POTENTIAL AIR BUBBLE WAS VISUALIZED USING THE SOUNDSTAR CATHETER. IT IS UNKNOWN IF MEDICAL/SURGICAL INTERVENTION WAS PROVIDED. THERE¿S NO INDICATION THAT EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE EVENT. THE PATIENT WAS REPORTED IN STABLE CONDITION. NO BWI PRODUCT MALFUNCTIONS WERE REPORTED. PHYSICIAN CAUSALITY OPINION IS UNKNOWN. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Air Embolism

  MAUDE report 10259594 ↗
• MalfunctionJun 3, 2020Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A SMARTABLATE¿ SYSTEM IRRIGATION PUMP (US) AND A HIGH FLOW ACTIVATION PROBLEM OCCURRED. IT WAS REPORTED THAT THE WHEEL FOR THE FLOW ON THE SMARTABLATE¿ SYSTEM IRRIGATION PUMP (US) WOULD NOT MOVE WHEN THEY WERE DELIVERING RADIOFREQUENCY (RF) THERAPY. THE CALLER STATED THAT THEY STOPPED ABLATION, MANUALLY MOVED THE WHEEL AND THAT RESOLVED THE ISSUE. THERE WAS NO REPORT OF PATIENT CONSEQUENCE. THE SALES REPRESENTATIVE WAS NOT PRESENT WHEN THE EVENT OCCURRED AND REPORTED IT WAS PROBABLY AN AV NODE ABLATION. THE STAFF STATED THAT THEY TRIED TO TURN THE WHEEL MANUALLY AND COULD NOT MOVE IT (WHICH IS NORMAL.) LATER AN AFIB ABLATION WAS DONE WITHOUT AN ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10113443 ↗
• MalfunctionDec 15, 2019Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED THAT A PATIENT, UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION (AFIB) WITH A SMARTABLATE¿ SYSTEM IRRIGATION PUMP, AND AN UNDETECTED AIR BUBBLES ISSUE OCCURRED. DURING ABLATION, WHEN THE TUBING WAS OPENED, THE TUBING WAS CLOUDY, EVEN WHEN FLUSHED. ADDITIONALLY, THE TUBING HAD MANY TINY BUBBLES AND LARGE BUBBLES TO PASS THROUGH THE PUMP, WITHOUT SETTING OFF THE SENSOR. THERE WAS NO REPORT OF PATIENT CONSEQUENCE. FOLLOW UP IS IN PROGRESS TO CLARIFY IF THE PUMP DID NOT DETECT THE BUBBLE DURING FLUSHING. THE OBSERVED CLOUDY TUBING HAS BEEN ASSESSED AS NOT MDR REPORTABLE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. THE UNDETECTED AIR BUBBLES ISSUE HAS BEEN ASSESSED AS AN MDR REPORTABLE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9471171 ↗
• MalfunctionDec 4, 2019Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED CARDIAC ARREST REQUIRING CARDIOPULMONARY RESUSCITATION. AN ISSUE OF UNDETECTED AIR BUBBLES WAS REPORTED AGAINST THE SMARTABLATE¿ SYSTEM IRRIGATION PUMP (US). THE PATIENT WENT INTO CARDIAC ARREST ABOUT 30 SECONDS AFTER THE ABLATION CATHETER WENT THROUGH THE NEW BAYLIS DEFLECTABLE SHEATH AND WAS RESUSCITATED BY CARDIOPULMONARY RESUSCITATION. THE PATIENT WAS STABLE AND TRANSFERRED TO THE CORONARY CARE UNIT (CCU) FOR OBSERVATION. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BUT HAS HAD NO RESIDUAL EFFECTS. PER THE LAST UPDATE, THE PATIENT WAS STILL IN THE HOSPITAL, OFF OF THE VENTILATOR AND DOING WELL. THE PHYSICIAN IS UNSURE OF THE CAUSALITY OF THE EVENT AND THERE WERE SEVERAL FACTORS HE CONSIDERED INCLUDING THE PATIENT¿S CONDITION. INITIALLY IT WAS REPORTED THAT THE PATIENT HAD AN AIR EMBOLISM THAT WAS BELIEVED TO COME FROM THE MAPPING CATHETER. THE PHYSICIAN ISN¿T CERTAIN THAT THE PATIENT INDEED HAD AN AIR EMBOLUS; THAT WAS HIS INITIAL THOUGHT JUST AFTER THE CASE, BUT IN THE DAYS AFTER THE INCIDE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9412482 ↗
• MalfunctionOct 31, 2019Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PAROXYSMAL PROCEDURE WITH A SMARTABLATE¿ SYSTEM IRRIGATION PUMP (US) AND ¿AIR BUBBLES UNDETECTED¿ EVENT OCCURRED. IT WAS REPORTED THAT THERE WERE BUBBLES OBSERVED IN THE SMARTABLATE¿ IRRIGATION TUBING SET THAT WERE NOT CAUGHT BY THE SMARTABLATE¿ SYSTEM IRRIGATION PUMP (US) BUBBLE SENSORS. THE PHYSICIAN NOTICED THEM FLOATING DOWNSTREAM CLOSE TO THE CATHETER HUB. THE STOPCOCK WAS IMMEDIATELY TURNED OFF TO THE PATIENT/CATHETER. THE SMARTABLATE¿ IRRIGATION TUBING SET WAS FLUSHED SEVERAL TIMES USING HIGHEST FLOW SETTING, BUT THE FLUSHING WAS UNSUCCESSFUL TO REMOVE THE BUBBLES. THE SMARTABLATE¿ IRRIGATION TUBING SET WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCES. THE BUBBLE ISSUE DESCRIBED IN THE EVENT WAS ASSESSED AS NOT REPORTABLE. BUBBLES IN THE TUBING SET CAN BE AN EXPECTED PART OF PROCEDURE SET UP, AND FLUSHING SHOULD BE PERFORMED IN ORDER TO REMOVE THE BUBBLES. A SAFETY FEATURE OF THE PUMP IS IN PLACE IN ORDER TO STOP FLOW IF AIR IS DETECTED. THE ISSUE OF THE AIR BUBBLES BEING UNDETECTED BY THE PUMP AS NO ERROR MESSAGE OR ALARM WAS GENERATED BY THE PUMP WAS ASSESSED AS A REPORTABLE MA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9264053 ↗
• InjuryMay 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT A PERSISTENT ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND A SMARTABLATE¿ SYSTEM IRRIGATION PUMP AND SUFFERED AIR EMBOLISM (REQUIRING CORONARY ANGIOGRAM AND 100% HIGH FLOW O2) AND VENTRICULAR FIBRILLATION (REQUIRING DEFIBRILLATION). DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE FLUSH LINE THAT WENT FROM THE ST JUDE SL1 LONG SHEATH TO THE ABLATION CATHETER WAS DRY, AND THERE WERE CHANGES IN THE ECG AFTER THAT. AIR EMBOLISM WAS CONFIRMED BY INTRACARDIAC ECHO (ICE), AND THE RIGHT VENTRICLE WAS NOT MOVING RIGHT ON THE ULTRASOUND. CORONARY ANGIOGRAM WAS PERFORMED AND 100% HIGH FLOW O2 WAS APPLIED. THE PATIENT WAS THEN DEFIBRILLATED MULTIPLE TIMES, THE PHYSICIAN BELIEVES THAT THE DEFIBRILLATION WAS WHAT BROKE UP THE EMBOLISM. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND WAS MOVED TO CT FOR A BRAIN SCAN TO SEE IF AIR WENT INTO THE BRAIN. THERE¿S NO INFORMATION REGARDING EXTENDED HOSPITALIZATION AND PATIENT¿S OUTCOME. IT WAS CONFIRMED THAT THE SHEATH USED WAS A ST. JUDE SL1 LONG SHEATH, NO BWI PREFACE SHEATH WAS USED. BIOSENSE WEBSTER MANUFACTURER'S REFER

  Patient problems: Air Embolism; No Code Available

  MAUDE report 8601957 ↗
• MalfunctionApr 12, 2019Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED A PATIENT UNDERWENT A ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A SMARTABLATE¿ SYSTEM IRRIGATION PUMP AND A HIGH FLOW ACTIVATION PROBLEM OCCURRED DURING ABLATION. IT WAS REPORTED THAT THE THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER WAS NOT IRRIGATING CORRECTLY. AFTER STARTING THE FIRST ABLATION PASS THE TEMPERATURE WAS HIGH. THE THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER WAS REPLACED BUT THE ISSUE PERSISTED. THE CUSTOMER CHECKED THE SMARTABLATE¿ SYSTEM IRRIGATION PUMP AND WAS NOTICED THAT THE PUMP¿S HIGH-FLOW WAS NOT WORKING PROPERLY. THE SMARTABLATE¿ SYSTEM IRRIGATION PUMP WAS REPLACED WITH ONE FROM ANOTHER ROOM AND THE ISSUE RESOLVED. THE ISSUE OF HIGH FLOW ACTIVATION PROBLEM HAS BEEN ASSESSED AS AN MDR REPORTABLE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8508892 ↗
• InjuryDec 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION WITH A PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE AND SMARTABLATE¿ SYSTEM IRRIGATION PUMP AND SUFFERED AORTIC AIR EMBOLISM REQUIRING A HEART CATHETERIZATION AND A BALLOON PUMP PLACEMENT IN THE AORTA. DURING THE PROCEDURE, ERROR 6150 APPEARED ON THE CARTO 3 SYSTEM WHEN THE SOUNDSTAR CATHETER WAS CONNECTED. THE ECO ADAPTER CABLE WAS EXCHANGED, AND THE ERROR RESOLVED. IT WAS ALSO REPORTED THAT TRANSSEPTAL PUNCTURE, THE CATHETERS WERE INTRODUCED ACROSS IN THE LEFT ATRIUM. THE PATIENT DEVELOPED AN AORTIC AIR EMBOLISM. THIS WAS NOTICED WHILE FAST ANATOMICAL MAPPING (FAM) IN THE LEFT ATRIUM, THE PATIENT'S BLOOD PRESSURE DECREASED. PERICARDIAL EFFUSION WAS RULED OUT WITH INTRACARDIAC ECHO (ICE) BUT DIAGNOSED THE AORTIC EMBOLISM. A CARDIAC CATHETERIZATION AND TRANSESOPHAGEAL ECHO (TEE) WERE PERFORMED, AND AN INTRA-AORTIC BALLOON PUMP WAS PLACED TO TREAT THE EMBOLISM. THE PATIENT WAS AWAKE, ALERT AND RESPONSIVE. EXTENDED HOSPITALIZATION WAS REQUIRED FOR A FORMAL NEUROLOGICAL EXAM. PATIENT¿S OUTCOME IS FULLY RECOVERED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVEN

  Patient problems: Air Embolism

  MAUDE report 8201638 ↗
• InjuryNov 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION (AFIB) WITH A SMARTABLATE¿ SYSTEM IRRIGATION PUMP AND SUFFERED AIR EMBOLISM REQUIRING AIR REMOVAL. DURING THE PROCEDURE, RIGHT CORONARY AIR EMBOLISM WAS DISCOVERED AS THE PHYSICIAN NOTICED AN ST SEGMENT ELEVATION. THE AIR WAS REMOVED FROM THE RIGHT CORONARY ARTERY BY A PRONTO EXTRACTION CATHETER. PATIENT WAS REPORTED TO BE IN STABLE CONDITION AFTER AIR REMOVAL. EXTENDED HOSPITALIZATION WAS REQUIRED FOR NEUROLOGICAL AND CARDIAC MONITORING. PATIENT¿S OUTCOME WAS IMPROVED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED.

  Patient problems: Air Embolism

  MAUDE report 8089929 ↗