ThermoCool SmartTouch D133603Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10846835009019), received between Jun 27, 2016 and Mar 6, 2025 — classified as 1 death, 14 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (3 reports).

8 other recalls cover devices cleared under the same FDA submission (P030031, P040036); they may or may not involve this specific model.

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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE ON THE PEBAX. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT A TEMPERATURE SENSOR ERROR OCCURRED. THE PHYSICIAN USED ANOTHER ONE PRODUCT THE SAME TYPE AND THE PROCEDURE WAS COMPLETED. THE CUSTOMER'S REPORTED TEMPERATURE SENSOR ISSUE 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. ON 12-FEB-2025, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND A HOLE IN THE PEBAX AND A REDDISH MATERIAL INSIDE THE PEBAX. THESE FINDINGS WERE REVIEWED AND ASSESSED THE ISSUE OF A ¿HOLE¿ IN THE PEBAX AS AN MDR REPORTABLE MALFUNCTION SINCE THE INTEGRITY OF THE DEVICE HAS BEEN COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21543501 ↗
• MalfunctionOct 29, 2024Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER (AFL) PROCEDURE WITH THERMOCOOL SMARTTOUCH FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE IN THE SURFACE OF THE PEBAX. INITIALLY IT WAS REPORTED THAT THE CATHETER PRESENTED WITH SENSOR 105 ERROR. THE CONNECTOR WAS CHANGED AND THE ERROR PERSISTED. THE CATHETER WAS CHANGED AND IT RESOLVED. THE PROCEDURE WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 07-OCT-2024, OBSERVED REDDISH MATERIAL AND A HOLE IN THE SURFACE OF THE PEBAX. THE EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF A HOLE IN THE SURFACE OF THE PEBAX ON 07-OCT-2024 AND HAVE ASSESSED THIS RETURNED CONDITION AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20563954 ↗
• MalfunctionSep 8, 2023Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A DAMAGE TO THE PEBAX. INITIALLY, IT WAS REPORTED THAT THERE WERE NO SIGNALS ON MAPPING CATHETER ON CARTO. THEY EXCHANGED THE CABLE WITH NO IMPROVEMENTS. THEN, THEY EXCHANGED THE CATHETER, AND THE PROCEDURE WAS CONTINUED. THERE WAS NO PATIENT CONSEQUENCE. THE SIGNAL ISSUE WAS ASSESSED AS NON MDR REPORTABLE. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT WAS REMOTE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 25-AUG-2023, THE PEBAX COMPONENT WAS FOUND OUT OF THE ORIGINAL PLACE AS IT WAS FOUND ON THE DOME. THE DAMAGE ON THE PEBAX WAS ASSESSED AS MDR REPORTABLE. THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING WAS 25-AUG-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17716135 ↗
• InjuryMay 24, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT ATRIAL FLUTTER LEFT (L-AFL) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER. THE PATIENT DEVELOPED A SMALL STROKE. IT WAS REPORTED THAT 2 HOURS POST LEFT SIDED ATYPICAL ATRIAL FLUTTER PROCEDURE PERFORMED YESTERDAY THE PATIENT DEVELOPED A SMALL STROKE. THE PHYSICIAN FEELS THAT IT WAS DUE TO THE LENGTH OF THE PROCEDURE. THE PATIENT WAS STABLE AND WILL BE DISCHARGED HOME TODAY. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS DISCOVERED POST USE OF BIOSENSE WEBSTER PRODUCTS. THERE IS NO INFORMATION ABOUT IF ANY INTERVENTION WAS PERFORMED. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS LENGTH OF PROCEDURE, NO PRODUCT MALFUNCTION AND PROCEDURE WAS A LEFT SIDED FLUTTER. PATIENT MADE A RECOVERY AND WENT HOME (B)(6) 2023. WAS TOLD BY THE PHYSICIAN THE PATIENT WAS OK TO LEAVE. UNSURE IF THERE ARE RESIDUAL EFFECTS. PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT AS PATIENT INTENDED ON AN OVERNIGHT STAY AND LEFT THE FOLLOWING DAY. OTHER RELEVANT HISTORY-HAD PREVIOUS ABLATION. THERE WAS NO EVIDENCE OF CHAR DURING THE PROCEDURE. THERE WAS NO EVIDENCE OF BLOOD THROMBUS/CLOT DURING PROC

  Patient problems: Stroke/CVA

  MAUDE report 16998306 ↗
• MalfunctionFeb 21, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE ON THE PEBAX. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT WHEN THE DOCTOR USED THE CATHETER, THE CATHETER COULD NOT FLEX. THERE WAS NO PATIENT CONSEQUENCE. THE CUSTOMER¿S REPORTED DEFLECTION ISSUE IS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE MOST LIKELY CONSEQUENCE IS AN INTRAPROCEDURAL DELAY. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH IS REMOTE. ON (B)(6) 2023, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THE PEBAX TO BE BROKEN. THIS FINDING WAS REVIEWED AND ASSESSED AS AN MDR REPORTABLE MALFUNCTION SINCE THE INTEGRITY OF THE DEVICE HAS BEEN COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16415197 ↗
• InjuryJan 20, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ISCHEMIC VENTRICULAR TACHYCARDIA - LEFT (L-ISVT) WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER. THE PATIENT SUFFERED A CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. DURING THE VT ABLATION WITH THE THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER, IT WAS NOTICED THAT PATIENT BLOOD PRESSURE DROPPED. CARDIAC ECHOGRAPHY REVEALED A CARDIAC TAMPONADE THAT WAS CONTROLLED BY A PERICARDIOCENTESIS. NO FURTHER COMPLICATION THAT THEY HAVE KNOWLEDGE, VT ABLATION PROCEDURE WAS FINISHED. SURGERY WAS DELAYED DUE TO THE REPORTED EVENT FOR 90 MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL INFORMATION WAS RECEIVED. THE EVENT HAPPENED INTRA-OP, DURING USE OF BIOSENSE WEBSTER PRODUCTS. IT WAS NOT KNOWN FOR SURE WHAT CAUSED THE EVENT, BUT IT WAS DISCOVERED IN MID OF AN ABLATION SESSION WITH THE THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER. IN OPINION OF THE PHYSICIAN, EVENT WAS ATTRIBUTABLE TO THE PATIENT CONDITION: APICAL ANEURYSM AND THE PROCEDURE. IT WAS NOT SUSPECTED THAT THERE WAS A PRODUCT FAILURE. PATIENT'S CONDITION WAS IMPROVED. TAMPONADE WAS CONTROLLED DURING THE PROCEDURE, AND VT ABLATION PROCEDURE WAS COMPLETED

  Patient problems: Cardiac Tamponade

  MAUDE report 16212861 ↗
• InjuryJun 30, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRY TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER. THE PATIENT SUFFERED TRANSIENT HEART BLOCK REQUIRING TEMPORARY TRANSVENOUS PACING (TVP). IT WAS REPORTED A PATIENT SUFFERED A TRANSIENT HEART BLOCK. THEY WERE MAPPING THE AVNRT WITH THE PENTARAY CATHETER, BOTH THE FAST AND SLOW PATHWAYS AND TOWARDS THE END OF THE PROCEDURE, WHEN THEY WERE ABLATING, THEY NOTICED THE HEART BLOCK. THEY CAME OFF ABLATION AND BEGAN RIGHT VENTRICLE (RV) PACING "TO GET THE HEART GOING AGAIN." THEY GOT THE HEART STABLE ENOUGH TO PUT IN A TEMPORARY PACEMAKER AFTER WHICH THE HEART RETURNED TO A NORMAL SINUS RHYTHM. THE PATIENT WAS STABLE AND ALL INTERVALS ASSOCIATED WITH THE SINUS RHYTHM WERE NORMAL WHEN HE AND THE PHYSICIAN LEFT THE ROOM. THE PATIENT WILL STAY OVERNIGHT FOR OBSERVATION. THE CASE WAS NOT PART OF A CLINICAL STUDY. THE CALLER ASKED THE PHYSICIAN WHAT THEIR OPINION WAS OF THE CAUSE AND THE PHYSICIAN INDICATED THAT DURING ABLATION, THE CATHETER SLIPPED AND BUMPED THE FAST PATHWAY BUT DID NOT ABLATE IT, WHICH IS WHY THE SINUS RHYTHM RETURNED. ADDITIONAL INFORMATION WAS R

  Patient problems: Heart Block

  MAUDE report 14880762 ↗
• MalfunctionFeb 21, 2020Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER FOR WHICH BIOSENSE WEBSTER INC.¿S PRODUCT ANALYSIS LAB HAS IDENTIFIED A HOLE IN THE PEBAX AREA. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT THE THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER WAS NOT SENSING FORCE CORRECTLY. THE PHYSICIAN NOTICED THAT THE FORCED SENSOR HAD TO BE DAMAGED AS THE FORCE VECTOR AND FORCE SENSED WAS NOT CONGRUENT. THERE WAS A DELAY OF 10 MINS WHILE REPLACING CONNECTION CABLE AND THEN REPLACING THE THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER. THE PROCEDURE WAS FINISHED SUCCESSFULLY WITHOUT ANY INCIDENT. THERE WERE NO PATIENT CONSEQUENCES. THE CUSTOMER¿S REPORTED ¿FORCE SENSOR¿ ISSUES WERE ASSESSED AS NOT 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 1/8/2020, THE COMPLAINT PRODUCT WAS RETURNED TO BIOSENSE WEBSTER INC.¿S (BWI) PRODUCT ANALYSIS LAB (PAL) FOR EVALUATION. INITIAL VISUAL ANALYSIS IDENTIFIED A REDDISH MATERIAL IN THE PEBAX SLEEVE. NO INTERNAL PARTS EXPOSED. ALTHOUGH FOREIGN MATERIAL WAS FOUND UNDERNEATH THE PEBAX, THERE IS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9739424 ↗
• MalfunctionDec 14, 2018Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER (AFL) PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER AND THERE WAS A BAD FORCE SENSOR. THE CABLE WAS REPLACED WITHOUT RESOLUTION. THE CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. NO PATIENT CONSEQUENCES WERE REPORTED. THE FORCE ISSUE WAS ASSESSED AS NOT REPORTABLE. THE ISSUE WAS HIGHLY DETECTABLE WHEN OCCURRING. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH, SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT WAS LOW. THE BIOSENSE WEBSTER PRODUCT ANALYSIS LAB RECEIVED THE DEVICE ON (B)(6) 2018 AND NOTED THAT THE CLEAR PEBAX SLEEVE HAD DARK REDDISH BROWN MATERIAL INSIDE IT. NO DAMAGE WAS FOUND ON THE SLEEVE. THIS ISSUE WAS ASSESSED AS NOT REPORTABLE SINCE THERE IS NO EVIDENCE OF DAMAGE TO THE PEBAX INTEGRITY. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH, SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT WAS REMOTE. ADDITIONAL ASSESSMENT WAS PERFORMED ON (B)(6) 2018 STATING THAT THE SCANNING ELECTRON MICROSCOPE (SEM) TESTING WAS PERFORMED ON THE DAMAGE AREA AND THE RESULTS SHOWED EVIDENCE OF MECHANICAL DAMAGE, STRESS MARKS, SCRATCHES AND A HOLE ON THE SURFACE OF THE PEBAX.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8163498 ↗
• InjuryMar 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER AND SUFFERED A CARDIAC ARREST REQUIRING CHEST COMPRESSIONS AND A SURGICAL INTERVENTION (IMPELLA LEFT VENTRICULAR ASSIST DEVICE). POST-PROCEDURE, PREMATURE VENTRICULAR CONTRACTIONS (PVCS) TRIGGERED NON-SUSTAINED VENTRICULAR TACHYCARDIA (VT) AND SUBSEQUENTLY SUSTAINED VT. IT WAS NOTICED ON THE EKG. CHEST COMPRESSIONS WERE INITIATED AND AN IMPELLA LEFT VENTRICULAR ASSIST DEVICE WAS INSERTED. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THERE IS NO INFORMATION ABOUT THE HOSPITALIZATION. THE PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION FOR THE CAUSE OF THIS ADVERSE EVENT. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. SINCE THIS ADVERSE EVENT REQUIRED MEDICAL/SURGICAL INTERVENTION OR PROLONGED HOSPITALIZATION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR REPORTABLE.

  Patient problems: Cardiac Arrest; No Code Available

  MAUDE report 7325851 ↗
• MalfunctionNov 14, 2017Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH TWO THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETERS AND A DEFLECTION ISSUE OCCURRED, AS BOTH CATHETERS WOULD NO LONGER DEFLECT. THE CATHETERS WERE EXCHANGED AND THE ISSUES RESOLVED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCE. THIS EVENT WAS ORIGINALLY ASSESSED AS NOT MDR REPORTABLE BECAUSE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH IS REMOTE. THE DEVICES WERE RETURNED TO THE BIOSENSE WEBSTER FAILURE ANALYSIS LAB AND DURING VISUAL INSPECTION ON (B)(6) 2017, IT WAS DISCOVERED THAT ONE DEVICE (LOT# 17708516M), HAD PEBAX DAMAGE. THE PEBAX BROKE AND INTERNAL PARTS WERE EXPOSED. THIS FINDING IS MDR REPORTABLE BECAUSE THE EXPOSURE TO INTERNAL PARTS POSES A POTENTIAL RISK TO THE PATIENT. THE AWARENESS DATE HAS BEEN RESET TO (B)(6) 2017, THE DATE OF THE REPORTABLE FINDING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7028324 ↗
• MalfunctionJun 15, 2017Hole In Material; Device Displays Incorrect Message; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER (AFL) PROCEDURE WITH A SMART TOUCH UNIDIRECTIONAL CATHETER. A FORCE SENSOR ERROR (ERROR 106) DISPLAYED ON THE CARTO 3 SYSTEM. THE CABLES WERE REPLACED WITH NO RESOLUTION. THE CATHETER WAS REPLACED AND THE ISSUE RESOLVED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCE. SINCE THE WARNING FUNCTIONED AS INTENDED, THIS FORCE SENSOR ERROR WAS ASSESSED AS NOT REPORTABLE. THE BIOSENSE WEBSTER FAILURE ANALYSIS LAB RECEIVED THE CATHETER FOR EVALUATION AND DISCOVERED ON MAY 4, 2017 THAT THE PRODUCT HAD TINY BROWNISH MATERIAL IN THE PEBAX. THIS ISSUE WAS ASSESSED AS NOT REPORTABLE. IF MATERIAL WAS FOUND UNDERNEATH THE PEBAX; HOWEVER, THERE IS NO DAMAGE TO THE PEBAX INTEGRITY, THEN THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH, SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT WAS REMOTE. AT THIS TIME, THERE WAS NO INFORMATION TO INDICATE THAT THE THERE WAS A BREAK IN THE INTEGRITY OF THE PEBAX. DURING FURTHER EVALUATION ON MAY 19, 2017, THE SCANNING ELECTRON MICROSCOPE (SEM) RESULTS SHOWED EVIDENCE OF A HOLE IN THE SURFACE OF THE PEBAX. SINCE THE CATHETER INTEGRITY HAD BEEN COMPRISED, THIS ISSUE HAS BEEN ASSESSED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6642610 ↗
• DeathMay 24, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER AND A SOUNDSTAR® 3D DIAGNOSTIC ULTRASOUND CATHETER AND SUFFERED A CARDIAC TAMPONADE (REQUIRING PERICARDIOCENTESIS AND SURGICAL INTERVENTION), CARDIAC ARREST (REQUIRING CARDIOPULMONARY RESUSCITATION), AND DEATH. DURING THE PROCEDURE, A TAMPONADE WAS CONFIRMED VIA ULTRASOUND. INITIAL PERICARDIOCENTESIS YIELDED 660ML OF FLUID. PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND WAS SCHEDULED TO BE TRANSFERRED TO THE CORONARY CARE UNIT FOR OBSERVATION. A LATER REPORT INDICATED THAT 2500ML WAS DRAINED. THORACOTOMY REVEALED A PERFORATION IN THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) AND RIGHT VENTRICULAR TRAUMA SECONDARY TO CHEST COMPRESSIONS. INTRACARDIAC ECHOCARDIOGRAM (ICE) CATHETER WAS IN THE PATIENT¿S HEART WHILE MONITORING THE TAMPONADE AND REMAINED THERE DURING CHEST COMPRESSIONS. IT WAS NOTED THAT THE ICE (SOUNDSTAR) CATHETER MAY HAVE CONTRIBUTED TO THE INJURIES. MEDICAL HISTORY INCLUDED STEROID MEDICATION THAT IMPAIRED THE INTEGRITY OF THE CARDIAC TISSUE, WHICH MADE IT IMPOSSIBLE FOR THE SURGEON TO REPAIR THE PERFORATION.

  Patient problems: Blood Loss; Cardiac Arrest; Cardiac Tamponade; Death

  MAUDE report 6589701 ↗
• InjuryApr 17, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING MAPPING, THE PATIENT BECAME HYPOTENSIVE AND A TAMPONADE WAS CONFIRMED VIA ECHOCARDIOGRAM. PERICARDIOCENTESIS WAS PERFORMED AND YIELDED 100 ML OF FLUID. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT. PATIENT OUTCOME HAS IMPROVED. THERE WERE NO FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS RELATED TO OPERATOR HANDLING. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A ST. JUDE MEDICAL BRK TRANSSEPTAL NEEDLE. SHEATH IN USE WAS A ST. JUDE MEDICAL SLO 8.5 FRENCH. GENERATOR WAS SET ON POWER CONTROL MODE AT 25 WATTS (NOT TITRATED) WITH STANDARD CUT-OFF VALUES. THERE IS NO INFORMATION REGARDING OVERALL ABLATION TIME AND LAST ABLATION CYCLE TIME AT THE SITE OF INJURY. IRRIGATED CATHETER FLOW WAS SET AT 17 ML/MIN. PATIENT RECEIVED ANTICOAGULANT DURING THE PROCEDURE WITH ACTIVATED CLOTTING TIME MAINTAINED BETWEEN 3

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension

  MAUDE report 6497774 ↗
• InjuryFeb 28, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE AND A TAMPONADE WAS CONFIRMED VIA ULTRASOUND. PERICARDIOCENTESIS WAS IN PROGRESS AT THE TIME OF COMPLAINT REPORT. THERE IS NO INFORMATION REGARDING EXTENDED HOSPITALIZATION OR PATIENT OUTCOME. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension

  MAUDE report 6364530 ↗
• InjuryDec 7, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PERSISTENT ATRIAL FIBRILLATION WITH A THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. AT THE END OF THE PROCEDURE, DURING THE VERIFICATION PHASE, THE PHYSICIAN ATTEMPTED TO PASS A SMARTTOUCH ABLATION CATHETER NEXT TO THE TRANSSEPTAL SHEATH. THE PHYSICIAN HAD A ¿BAD SENSATION¿ AND IMMEDIATELY REMOVED THE CATHETER. PATIENT QUICKLY BECAME HYPOTENSIVE. A PERICARDIOCENTESIS WAS PERFORMED AND YIELDED AN UNKNOWN AMOUNT OF FLUID. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION UPON LEAVING THE PROCEDURE ROOM. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THIS ADVERSE EVENT FOR MONITORING AND HAS SINCE FULLY RECOVERED WITH NO RESIDUAL EFFECTS. FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT INCLUDE THE PATIENT¿S MEDICAL HISTORY OF VALVULOPATHY WITH SURGICAL REPAIR SEVERAL YEARS AGO. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS RELATED TO PATIENT ANATOMY. IT WAS ALSO NOTED THAT THE CATHETER LIKELY TORE THE SEPTUM. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A ST. JUDE MEDICAL BRK XS

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension

  MAUDE report 6151957 ↗
• InjuryDec 7, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT A PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. PRE-PROCEDURE, IT WAS NOTED THAT PATIENT HAD A SMALL, PRE-EXISTING PERICARDIAL EFFUSION. WHILE ABLATING IN THE LEFT ATRIUM NEAR THE RIGHT PULMONARY VEINS, THE PATIENT BECAME HYPOTENSIVE. THE SMALL PRE-EXISTING EFFUSION HAD GROWN SIGNIFICANTLY LARGER AND A TAMPONADE WAS CONFIRMED VIA INTRACARDIAC ECHOCARDIOGRAM. A PERICARDIOCENTESIS WAS PERFORMED AND YIELDED AN UNKNOWN AMOUNT OF FLUID. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION FOLLOWING THE PERICARDIOCENTESIS. REMAINDER OF PROCEDURE WAS ABORTED. THE PATIENT WAS UNDER OBSERVATION AT THE TIME THIS COMPLAINT WAS REPORT TO BIOSENSE WEBSTER INC. (BWI). THERE IS NO INFORMATION REGARDING EXTENDED HOSPITALIZATION OR PATIENT OUTCOME. THERE WERE NO PATIENT FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION. HOWEVER, IT WAS NOTED THAT THERE WAS NO EVIDENCE THAT IT WAS CAUSED BY ANY BWI PRODUCTS. TRANSSEPTAL PUNCTURE WAS PERFORMED W

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension

  MAUDE report 6151214 ↗
• InjuryNov 21, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PATIENT, OVER (B)(6), UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED A CARDIAC TAMPONADE, WHICH REQUIRED PERICARDIOCENTESIS. WHILE MAPPING, SOMETIME BETWEEN TRANSSEPTAL AND ABLATION, A PERICARDIAL EFFUSION WAS NOTICED AS THE PATIENT'S BLOOD PRESSURE DROPPED. NO ABLATIONS WERE PERFORMED. THE PERICARDIAL EFFUSION WAS CONFIRMED BY ECHOCARDIOGRAM. A PERICARDIOCENTESIS WAS PERFORMED AND 1500CC OF FLUID WAS REMOVED. POST PROCEDURE THE PATIENT WAS STABLE AND TRANSFERRED TO THE INTENSIVE CARE UNIT FOR OBSERVATION (ICU). THE PATIENT WAS MONITORED IN THE ICU OVERNIGHT AND REQUIRED ADDITIONAL DAYS IN THE TELEMETRY UNIT POST-ICU. THE PATIENT¿S CONDITION HAS SINCE IMPROVED. THE PHYSICIAN WAS UNSURE EXACTLY WHEN THE EFFUSION OCCURRED. HOWEVER, BELIEVES IT HAPPENED DURING THE TRANSSEPTAL PUNCTURE. THERE WAS NO PRODUCT MALFUNCTION. A TRANSSEPTAL PUNCTURE WAS DONE WITH A BAYLIS NEEDLE. A ST JUDE MEDICAL SL1 SHEATH WAS USED DURING THE PROCEDURE. THE PATIENT RECEIVED ANTICOAGULANT DURING THE PROCEDURE, HOWEVER THE ACTIVATED CLOTTING TIME IS UNKNOWN. IRRIGATION FLOW WAS SET TO 2ML/MIN DURING MAPPING

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 6119519 ↗
• InjuryNov 3, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL SMARTTOUCH UNIDIRECTIONAL CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. PRIOR TO THE PROCEDURE, THE PATIENT ALREADY HAD A DOCUMENTED PERICARDIAL EFFUSION. DURING THE CASE AND AFTER ANTICOAGULANTS WERE ADMINISTERED, THE EFFUSION WAS FOUND TO HAVE GROWN. AFTER THE CASE WAS COMPLETED, A PERICARDIOCENTESIS WAS PERFORMED ON THE PATIENT, WITH AN UNKNOWN AMOUNT OF FLUID WITHDRAWN. IT IS NOT KNOWN IF EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THIS EVENT, BUT THE PATIENT RECOVERED FULLY WITH NO RESIDUAL EFFECTS. THE PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION FOR THIS EVENT. IT IS UNKNOWN IF THERE WERE ANY FACTORS, SUCH AS PATIENT ANATOMY OR DISEASE, THAT MAY HAVE CONTRIBUTED TO THIS EVENT. THE EXACT TIME OF INJURY IS UNKNOWN, AS IS THE OVERALL ABLATION TIME. THE POWER DELIVERED RANGED FROM 20-30W (NOT TITRATED) DURING THE CASE. A HEPARIN BOLUS/DRIP WAS ADMINISTERED TO THE PATIENT, BUT ACTIVATED CLOTTING TIMES ARE UNKNOWN. THE TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A ST. JUDE MEDICAL SJM BRK-1 71CM NEEDLE, AND THE SHEATH IN USE WAS A ST. JUDE MEDICA

  Patient problems: Atrial Fibrillation; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 6077039 ↗
• InjuryOct 14, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. AFTER THE PROCEDURE WAS COMPLETED AND THE CATHETERS WERE REMOVED, THE PHYSICIAN WAS DOING A FINAL REVIEW WITH AN INTRACARDIAC ECHOCARDIOGRAM CATHETER WHEN A TAMPONADE WAS OBSERVED. PATIENT WAS ASYMPTOMATIC. PERICARDIOCENTESIS YIELDED AN UNKNOWN AMOUNT OF FLUID. PATIENT LEFT THE LAB IN STABLE CONDITION. THERE IS NO INFORMATION REGARDING EXTENDED HOSPITALIZATION. THERE WERE NO FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. IT WAS NOTED THAT THE PHYSICIAN DID NOT KNOW AT WHAT POINT DURING THE PROCEDURE THE INJURY OCCURRED. PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A ST. JUDE MEDICAL BRK-1 71CM TRANSSEPTAL NEEDLE. SHEATH USED WAS A ST. JUDE MEDICAL SL1 63CM 8.5 FRENCH. GENERATOR SETTINGS THROUGHOUT THE PROCEDURE INCLUDED: POWER AT 25-30 WATTS (NOT TITRATED) AND TEMPERATURE CUT-OFF AT 43 DEGREES CELSIUS. GENERATOR PARAMETERS, OVERALL ABLATION TIME, AND LAST ABLATION TIME AT THE SITE OF INJURY ARE NOT KNOWN. IRRIGATED CATHETER F

  Patient problems: Cardiac Tamponade

  MAUDE report 6031211 ↗
• InjuryAug 31, 2016No Display/Image

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) WITH A THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, THE SMARTABLATE GENERATOR WOULD NOT DISPLAY IMPEDANCE FOR THE TWO (2) 8MM NAVIGATIONAL BI-DIRECTIONAL CATHETERS. THE CABLES WERE REPLACED, GENERATOR WAS RE-BOOTED, GENERATOR WAS EXCHANGED, AND PACE ROUTING WAS CONFIRMED TO BE DISABLED WITHOUT SUCCESS. THE 8MM NAVIGATIONAL BI-DIRECTIONAL CATHETERS WERE EXCHANGED FOR A THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL CATHETER. THE SMARTABLATE GENERATOR INITIALLY DID NOT DISPLAY IMPEDANCE FOR THE SMARTTOUCH. THE CATHETER CONNECTOR WAS RE-SEATED INTO THE GENERATOR AND THE ISSUE WAS RESOLVED. DURING MAPPING WITH THE SMARTTOUCH CATHETER, THE PATIENT BECAME HYPOTENSIVE AND TAMPONADE WAS CONFIRMED VIA INTRACARDIAC ECHOCARDIOGRAM. PERICARDIOCENTESIS YIELDED 150-200CC. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Cardiac Tamponade; Discharge; Low Blood Pressure/ Hypotension

  MAUDE report 5917610 ↗
• InjuryJun 29, 2016Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT, (B)(6), FEMALE, UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A SMART TOUCH UNIDIRECTIONAL CATHETER AND SUFFERED A CARDIAC TAMPONADE WHICH REQUIRED A PERICARDIOCENTESIS AND A SURGICAL WINDOW. THE PATIENT'S MEDICAL HISTORY IS UNKNOWN. DURING MAPPING, A PERICARDIAL EFFUSION WAS FOUND WHEN THE PATIENT BEGAN EXPERIENCING CHEST PAIN. IT WAS CONFIRMED WITH INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AND A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS MOVED TO THE OPERATING ROOM FOR A SURGICAL WINDOW. NO TRANSSEPTAL PUNCTURE OR ABLATION HAD BEEN PERFORMED. THE PATIENT RECEIVED ANTICOAGULATION IN THE PROCEDURE AND THE ACT WAS MAINTAINED AT 183. THERE WERE NO ERROR MESSAGES OBSERVED ON THE BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. THE PATIENT DID REQUIRE EXTRA HOSPITALIZATION OF A DAY FOR MONITORING. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AT THE TIME THE COMPLAINT WAS REPORTED. THE PATIENT FULLY RECOVERED WITH NO RESIDUAL EFFECTS. THERE WERE NO FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION FOR THE CAUSE OF THIS ADVERSE EVENT. SINCE THIS ADVERSE EVENT REQUIRED MEDICAL OR SURGICAL INTER

  Patient problems: Cardiac Tamponade; Chest Pain; Pericardial Effusion

  MAUDE report 5759525 ↗
• InjuryJun 27, 2016High impedance

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL SMARTTOUCH UNIDIRECTIONAL CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING ABLATION, AN EFFUSION WAS OBSERVED VIA INTRACARDIAC ECHOCARDIOGRAM. ABLATION CONTINUED, AS THE PATIENT WAS NORMOTENSIVE. SHORTLY THEREAFTER, THE PATIENT BECAME HYPOTENSIVE AND PERICARDIOCENTESIS WAS PERFORMED, YIELDING 600CC. PERICARDIAL FLUID WAS RETURNED TO THE PATIENT. ANTICOAGULANTS WERE ADMINISTERED. PATIENT WAS REPORTED TO BE IN STABLE CONDITION AT THE TIME OF COMPLAINT REPORT. THERE IS NO INFORMATION REGARDING EXTENDED HOSPITALIZATION OR PATIENT OUTCOME. THERE WERE NO FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. IT WAS NOTED THAT THE INJURY MAY HAVE OCCURRED DURING TRANSSEPTAL ACCESS. PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION. IT WAS ALSO REPORTED THAT AT THE BEGINNING OF THE PROCEDURE, IMPEDANCE READINGS WERE HIGHER THAN NORMAL. IT WAS NOTED THAT THE PATIENT HAD A LARGER THAN AVERAGE BODY HABITUS. INDIFFERENT ELECTRODE WAS CHANGED WITHOUT RESOLUTION. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A ST. JUDE MEDICAL BRK-1 NEEDLE 71CM AND A ST. JUDE MEDICA

  Patient problems: Cardiac Tamponade; Fluid Discharge; Low Blood Pressure/ Hypotension; Pericardial Effusion; Tissue Damage

  MAUDE report 5751981 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P030031, P040036. One submission often covers many models, so check the product and lot details in each record.

• Z-0169-2023 · Sep 7, 2022 · Open, Classified
  THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac electrophysiological mapping (stimulation and recording) and, in con
• Z-0139-2015 · Oct 19, 2014 · Terminated
  ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.
• Z-0981-2012 · Nov 22, 2010 · Terminated
  EZ Steer ThermoCool Nav Part Number D-1292-03-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
• Z-0980-2012 · Nov 22, 2010 · Terminated
  EZ Steer ThermoCool Nav Part Number D-1292-02-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
• Z-0979-2012 · Nov 22, 2010 · Terminated
  EZ Steer ThermoCool Nav Part Number D-1292-01-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
• Z-0983-2012 · Nov 22, 2010 · Terminated
  EZ Steer ThermoCool Nav Part Number D-1292-05-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
• Z-0982-2012 · Nov 22, 2010 · Terminated
  EZ Steer ThermoCool Nav Part Number D-1292-04-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
• Z-0057-06 · Aug 8, 2005 · Terminated
  Thermocool Irrigated Catheters Celsius LABEL US Part Number# EU CATALOG # L-1189-01-S D17TCBLRT 35Q-13R PMA; L-1189-02-S D17TCDLRT 35Q-33R PMA; L-1189-03-S D17TCFLRT 35Q-53R P