THERMOCOOL SMARTTOUCH SF D134802Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10846835010152), received between Dec 28, 2016 and Aug 6, 2024 — classified as 11 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (6 reports).

8 other recalls cover devices cleared under the same FDA submission (P030031); 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A SEPARATION BETWEEN THE PEBAX AND ELECTRODE SECTION. THERE WAS BLOOD ON THE TIP OF THE THERMOCOOL SMARTTOUCH SF CATHETER UPON INSPECTION. WHEN THE CATHETER WAS REPLACED, THE ISSUE WAS RESOLVED. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THERE WAS NO DIFFICULTY EXPERIENCED WHILE MANEUVERING THE CATHETER OR DURING THE WITHDRAWAL. NO PHYSICAL DAMAGE WAS SEEN ON THE CATHETER PEBAX. PHYSICIAN TRIED TO WIPE OFF THE BLOOD AND REALIZED IT WAS INSIDE THE TIP. IT WAS BLOOD INSIDE, NO CLOT. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 12-JUL-2024 OBSERVED A SEPARATION BETWEEN THE PEBAX AND ELECTRODE SECTION AND REDDISH MATERIAL INSIDE OF IT. THE EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF A SEPARATION BETWEEN THE PEBAX AND ELECTRODE SECTION ON 12-JUL-2024 AND HAVE ASSESSED THIS RETURNED CONDITION AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19924565 ↗
• MalfunctionMar 19, 2024Communication or Transmission Problem; Electrical Shorting; Communication or Transmission Problem; Electrical Shorting

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION - PAROXYSMAL PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND ALL SIGNALS WERE LOST ON THE BODY SURFACE (BS), ELECTROCARDIOGRAM (ECG), AND INTRACARDIAC (IC) CHANNELS. SIGNAL INTERFERENCE PREVENTED ALL CARDIAC MONITORING. AFTERWARD, A CURRENT LEAKAGE ERROR WAS IDENTIFIED. THE CABLE AND CATHETER WERE CHANGED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18935709 ↗
• MalfunctionFeb 13, 2024Obstruction of Flow; Contamination /Decontamination Problem; Obstruction of Flow; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND THE CATHETER WOULD NOT IRRIGATE AND THERE WAS A PLASTIC FILM ON THE TIP. IT WAS REPORTED BY THE BWI REPRESENTATIVE THAT DURING A PROCEDURE THE CATHETER WOULD NOT IRRIGATE AND WAS FULLY OCCLUDED. THE CALLER STATED THAT WHEN THEY PULLED OUT THE CATHETER, THE PHYSICIAN SAID IT LOOKED AS THOUGH THERE WAS A PLASTIC FILM ON THE TIP OF THE CATHETER. TO TROUBLESHOOT THE PHYSICIAN TRIED TO IRRIGATE THE CATHETER WITHOUT RESOLUTION. THE CATHETER WAS REPLACED, THE ISSUE WAS RESOLVED, AND THE PROCEDURE WAS CONTINUED. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS LATER RECEIVED INDICATING THE CATHETER WAS FLUSHED MULTIPLE TIMES WITH THE CATHETER IN THE PATIENT, BUT WITH THE STOPCOCK CLOSED TO THE PATIENT. IRRIGATION FLOW FROM THE PUMP WAS NORMAL WHEN THE STOPCOCK WAS OFF TO THE PATIENT. AFTER NUMEROUS FLUSHING ROUNDS FAILED TO REAOLVE THE ISSUE, THE CATHETER WAS WITHDRAWN FROM THE BODY AND THE TIP WAS VISUALLY INSPECTED AND FOUND TO BE OCCLUDED. THE FOREIGN MATERIAL HAD A CLOUDY WHITE APPEARANCE AND COVERED THE ENTIRE T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18694457 ↗
• MalfunctionDec 4, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A CUT ON THE PEBAX. INITIALLY IT WAS REPORTED THAT THE CARTO 3 SYSTEM DISPLAYED A FORCE SENSOR ERROR (ERROR CODE UNKNOWN) WHEN THE CATHETER WAS CONNECTED TO THE PATIENT INTERFACE UNIT (PIU). THEY RESEATED THE CATHETER TO THE PIU AND THE ISSUE PERSISTED. THE CABLE WAS REPLACED WITHOUT RESOLUTION. WHEN THE CATHETER WAS REPLACED, THE ISSUE WAS RESOLVED AND THE PROCEDURE WAS CONTINUED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. THE FORCE 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 06-NOV-2023 THERE WAS A CUT ON THE PEBAX AND FOREIGN REDDISH MATERIAL WAS INSIDE OF IT. THE CUT ON THE PEBAX WAS ASSESSED AS MDR REPORTABLE. THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING WAS 06-NOV-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18257399 ↗
• InjuryNov 20, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB)- PAROXYSMAL PROCEDURE WHICH INCLUDED THE USE OF AN UNIDENTIFIED THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER (STSF) AND EXPERIENCED CARDIAC TAMPONADE THIRTY (30) MINUTES AFTER THE PROCEDURE AND A PERICARDIOCENTESIS WAS PERFORMED. IT WAS REPORTED THEY HAD TEMPERATURE ALERT ON THE NGEN CONSOLE WITH THE STSF CATHETER, BUT THEY WERE NOT USING IT AT THIS MOMENT. THEY WERE MAPPING THE LEFT ATRIUM WITH LASSO CATHETER. THE TEMPERATURE WAS EITHER NOT DISPLAYED OR NOT ACCURATE. IT WAS NOTED THAT THE STSF CATHETER WAS CONNECTED BUT NOT IN THE LEFT ATRIUM YET. THEY SOLVED THE ISSUE BUT WHEN THEY CONNECTED THE STSF CATHETER IN THE LEFT ATRIUM, THEY SUDDENLY GOT A LOT OF NOISE OF ALL CATHETERS (ECG, LASSO, STSF) AND HAD THE ALERT ¿CURRENT LEAKAGE¿. THEY TRIED TO CHANGE THE CATHETERS AND THE CATHETERS CABLES BUT STILL HAD THE SAME ISSUE. ALSO, THE IMPEDANCE WAS VISIBLE BUT NOT THE TEMPERATURE. AS A SOLUTION, THEY SWITCHED TO SMA (SMART ABLATE) SYSTEM. THE PATIENT IS ALIVE AND FULLY RECOVERED. A TRANSSEPTAL PUNCTURE WAS PERFORMED WITH ABBOTT SLO SHEATH AND BRK NEEDLE AND ABLATION WAS PERFORMED. NO EVIDENCE WITH STE

  Patient problems: Cardiac Tamponade

  MAUDE report 18178874 ↗
• MalfunctionAug 7, 2023Display or Visual Feedback Problem; Incorrect, Inadequate or Imprecise Result or Readings; Contamination /Decontamination Problem; Display or Visual Feedback Problem; Incorrect, Inadequate or Imprecise Result or Readings; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A MICROSCOPIC ANALYSIS REVEALED A HOLE IN THE PEBAX EXPOSING INTERNAL COMPONENTS. IT WAS INITIALLY REPORTED THAT THE CARTO 3 SYSTEM WAS DISPLAYING INACCURATE FORCE READINGS, THE CATHETER WAS "FLINGING OFF OF THE SCREEN", AND THERE WAS BLOOD POOLING AT THE TIP OF THE CATHETER. THERE WAS ALSO AN ULTRASOUND MAGNETIC SENSOR WHICH WOULD RESOLVE WHEN THE ECO CABLE WAS DISCONNECTED. THE CALLER CONFIRMED THAT THEY WERE NOT USING ULTRASOUND AFTER THE TRANSSEPTAL PUNCTURE. THE CALLER STATED THAT THEY WOULD MONITOR THIS ISSUE AND CALL BACK IF NEEDED. TO TROUBLESHOOT THE CABLE WAS REPLACED WITHOUT RESOLUTION. THE CATHETER WAS REPLACED, THE ISSUE WAS RESOLVED, AND THE PROCEDURE WAS CONTINUED. THE CUSTOMER¿S REPORTED FORCE, VISUALIZATION AND POOLED BLOOD IN THE CATHETER TIP ARE NOT CONSIDERED TO BE MDR REPORTABLE ISSUES SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT IS REMOTE. ON 10-JUL-2023, THE BWI PAL R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17470953 ↗
• MalfunctionDec 9, 2022High Readings; Contamination /Decontamination Problem; High Readings; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB OBSERVED FOREIGN MATERIAL INSIDE THE PEBAX WITH EXTERNAL DAMAGE. INITIALLY IT WAS REPORTED THAT THE CONTACT FORCE READINGS SPIKED TO A HIGH READING WHEN THEY WENT ON TO ABLATE. THE CATHETER WAS EXCHANGED AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED. AFTER THE PROCEDURE, THEY INSPECTED THE CATHETER AND SAW BLOOD INSIDE THE CONTACT FORCE SENSOR HOUSING. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE SHEATH USED WAS THE VIZIGO 8.5 F. NO DIFFICULTY MANEUVERING THE CATHETER WAS REPORTED BY THE PHYSICIAN. THE CALLER WAS UNABLE TO CONFIRM IF THERE WAS PHYSICAL DAMAGE. A PICTURE WAS PROVIDED. THE HIGH FORCE READING WAS ASSESSED AS NOT MDR 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 REPORTED BLOOD INSIDE THE CONTACT FORCE SENSOR HOUSING WAS ASSESSED AS NOT MDR REPORTABLE FOR FOREIGN MATERIAL INSIDE THE PEBAX WITH NO EXTERNAL DAMAGE. T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15950837 ↗
• InjuryNov 19, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AN 82 YEAR-OLD-FEMALE (WEIGHT REPORTED AS ¿VERY SMALL¿) UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) - LEFT ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. IT WAS REPORTED BY THE BWI REPRESENTATIVE THAT DURING A LEFT SIDED PREMATURE VENTRICULAR CONTRACTION (PVC) PROCEDURE THE PATIENTS PRESSURE DROPPED AND IT WAS OBSERVED BY INTRA-CARDIAC ULTRASOUND THAT THE PATIENT DEVELOPED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED IN WHICH 200 CC'S WAS REMOVED FROM THE PERICARDIAL SPACE. THE PATIENT WAS STABILIZED AND TRANSFERRED TO THE CRITICAL CARE UNIT (CCU) FOR OBSERVATION. THE PATIENT HAD 2 EXTRA DAYS IN THE HOSPITAL BECAUSE OF THE PERICARDIAL DRAIN. ADDITIONAL INFORMATION RECEIVED INDICATED THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS THAT IT WAS PROCEDURE RELATED. THE PHYSICIAN BELIEVES IT WAS CAUSED BY THE PROCEDURE, NOT BY ANYTHING CATHETER RELATED. OUTCOME FROM THE ADVERSE EVENT WAS REPORTED AS FULLY RECOVERED (NO RESIDUAL EFFECTS). A SMARTABLATE GENERATOR WAS USED DURING THE PROCEDURE WITH THE CORRECT CATHET

  Patient problems: Cardiac Tamponade

  MAUDE report 15830496 ↗
• InjurySep 24, 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® SF BI-DIRECTIONAL NAVIGATION CATHETER AND PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. IT WAS REPORTED THAT AFTER THE PROCEDURE WAS COMPLETED, A CARDIAC TAMPONADE WAS DISCOVERED. THE PATIENT EXPERIENCED BLOOD PRESSURE FLUCTUATION BETWEEN HIGH AND LOW THROUGHOUT THE PROCEDURE. AFTER THE PROCEDURE WAS COMPLETED, THE PHYSICIAN CONFIRMED THE CARDIAC TAMPONADE WITH TRANSTHORACIC ECHOCARDIOGRAM (TTE). MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS, 200 CC'S OF FLUID WERE REMOVED FROM THE HEART. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. IT WAS ALSO REPORTED THAT WHILE MAPPING WITH THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER DURING THE PROCEDURE, THE MAP APPEARED "WEIRD" ON THE CARTO 3 SYSTEM. THE MAP ON THE CARTO 3 SYSTEM APPEARED TO HAVE AN EXTRA FAST ANATOMICAL MAPPING (FAM) LIKE THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER HAD BEEN PUSHED OUT OF THE TISSUE. THE PHYSICIAN STATED THAT HE BELIEVED THE CARDIAC TAMPONADE OCCURRED ON THE RIGHT SIDE OF THE HEART. THE

  Patient problems: Cardiac Tamponade

  MAUDE report 15479861 ↗
• InjuryAug 30, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITATION HAS BEEN REVIEWED: SASAKI W, NAKATANI Y, TAKE Y, KISHI S, NAITO S. TRANSIENT LEFT PHRENIC NERVE PARALYSIS AFTER ETHANOL INFUSION INTO THE VEIN OF MARSHALL. J CARDIOVASC ELECTROPHYSIOL. 2022 JUN 13. DOI: 10.1111/JCE.15593. EPUB AHEAD OF PRINT. PMID: 35695797. OBJECTIVE/METHODS/STUDY DATA: THIS STUDY AIMED TO COMPARE THE CLINICAL OUTCOMES OF PULMONARY VEIN ISOLATION (PVI) ALONE AND PWI IN ADDITION TO PVI (PVI¿+¿PWI) IN PATIENTS WITH NON-PAROXYSMAL ATRIAL FIBRILLATION (AF) USING A LESION SIZE PREDICTION MODULE. THIS STUDY IS A SUB-ANALYSIS OF THE RECENTLY PUBLISHED PROSPECTIVE MULTICENTRE OBSERVATIONAL STUDY CALLED ALCOHOLAF (ASSOCIATION OF ALCOHOL CONSUMPTION WITH OUTCOME OF CATHETER ABLATION OF AF). IN THIS SUB-ANALYSIS, PATIENTS WITH NON-PAROXYSMAL AF IN WHOM PVI ALONE OR PVI+PWI WAS PERFORMED USING THE LESION SIZE PREDICTION MODULE WERE INCLUDED. FREEDOM FROM ATRIAL TACHYARRHYTHMIA WAS COMPARED BETWEEN PVI ALONE AND PVI+PWI GROUPS USING PROPENSITY SCORE ANALYSES. OF THE 3474 PATIENTS REGISTERED IN THE ALCOHOL-AF STUDY, 572 PATIENTS (AGE 65.6+10.1 YEARS, MALE 77.4%, LONGSTANDING PERSISTENT AF 25.5%) WERE

  Patient problems: Arrhythmia; Cardiac Tamponade; Cardiogenic Shock; Heart Failure/Congestive Heart Failure; Hemorrhage/Blood Loss/Bleeding; Pericarditis; Pseudoaneurysm

  MAUDE report 15317757 ↗
• InjuryAug 26, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN PERSISTENT ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND AN ISMUS®CATH ELECTROPHYSIOLOGY CATHETER WITH AUTO ID. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. IT WAS REPORTED THAT A COUPLE OF HOURS AFTER THE PROCEDURE WAS COMPLETED, A PERICARDIAL EFFUSION WAS NOTICED. THE PATIENT EXPERIENCED CHEST PAIN AND HIGH BLOOD PRESSURE. THE PERICARDIAL EFFUSION WAS CONFIRMED WITH TTE. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND 500 CC¿S OF FLUID WERE REMOVED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PHYSICIAN WAS UNSURE OF HOW THE ISSUE OCCURRED BUT THAT HE BELIEVED IT COULD HAVE BEEN CAUSED BY THE 7FR ATRIAL DEFL CATH-CARTO 3. THE PATIENT WAS BEING SENT HOME ON (B)(6) 2022. ADDITIONAL INFORMATION WAS RECEIVED. THIS ADVERSE EVENT WAS DISCOVERED POST USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS THAT MAYBE IT WAS THE DUADECA CATHETER. THE PATIENT OUTCOME OF THE ADVERSE EVENT IS FULLY RECOVERED. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT

  Patient problems: Cardiac Tamponade

  MAUDE report 15306432 ↗
• MalfunctionMay 9, 2022Image Orientation Incorrect; Material Puncture/Hole; High Readings; Image Orientation Incorrect; Material Puncture/Hole; High Readings

  A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB IDENTIFIED A HOLE ON THE PEBAX WITH REDDISH MATERIAL INSIDE. THE FINDING WAS IDENTIFIED ON 13-APR-2022. DURING THE PROCEDURE, THE CARTO 3 SYSTEM WAS DISPLAYED A HIGH FORCE READING WHEN GOING ON ABLATION. ADDITIONALLY, THE FORCE VECTOR WAS POINTING STRAIGHT BACK. THE CATHETER WAS REPLACED, AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED. HIGH FORCE IS NOT MDR-REPORTABLE. FORCE VECTOR ORIENTATION ISSUE IS NOT MDR-REPORTABLE. HOLE IN THE PEBAX IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14333088 ↗
• InjuryDec 8, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT FEMALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING MONITORING. IT WAS REPORTED THAT THE PATIENT SUFFERED A PERICARDIAL EFFUSION DURING THE PROCEDURE. THE REPORTER STATED THAT "THE PHYSICIAN STATED THAT DURING THE PROCEDURE THERE WAS RESISTANCE WHEN ADVANCING THE LASSO AND ACUNAV CATHETER. THE LASSO CATHETER WAS USED FOR MAPPING FOR ABOUT 5-10 MINUTES. THE PHYSICIAN NOTICED WEIRD ANATOMY, SO THEY ADVANCED THE ABLATION CATHETER TO MAP. THE PATIENT'S BLOOD PRESSURE DROPPED. THE ACUNAV CATHETER WAS USED TO PERFORM AN INTRACARDIAC ECHO AND THE PHYSICIAN CONFIRMED THE PRESENCE OF AN EFFUSION. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED, AND A SMALL EFFUSION WAS CONFIRMED. THE ABLATION CATHETER WAS ADVANCED, AND THE PHYSICIAN NOTED UNUSUAL GEOMETRY, NO ABLATION WAS PERFORMED, AND ALL OF THE CATHETERS WERE REMOVED AT THIS POINT. THE PHYSICIAN GAVE PROTAMINE AND CLOSED. THE PHYSICIAN USED TEE TO CONTINUE MONITORING AND CONFIRMED THE EFFUSION WAS NOT GROWING. THE PATIENT WENT TO THE INTENSIVE CARE UNIT (ICU). AFTER THE PROCEDUR

  Patient problems: Cardiac Tamponade

  MAUDE report 12958395 ↗
• InjuryOct 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT ((B)(6)) UNDERWENT CARDIAC ABLATION PROCEDURE FOR ATRIAL FIBRILLATION (AFIB) WITH THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. IT WAS REPORTED DURING AN ATRIAL FIBRILLATION CASE, A PERICARDIAL EFFUSION WAS NOTICED. CALLER REPORTED THAT THE PATIENT HAD A TRACE PERICARDIAL EFFUSION BEFORE THE PROCEDURE STARTED. THE PHYSICIAN BELIEVES THE PERICARDIAL EFFUSION GREW THROUGHOUT ABLATION. CALLER REPORTED THAT THE PHYSICIAN ALSO BELIEVES THE PERICARDIAL EFFUSION MAY HAVE WORSENED WHEN THE ST. JUDE SL-0 SHEATH AND WIRE WERE CROSSING THE SEPTUM, AND THE SHEATH "DEEP DIVED" INTO THE LEFT SUPERIOR VEIN, OR DUE TO HEPARINIZATION DURING THE ABLATION. THE PERICARDIAL EFFUSION WAS CONFIRMED BY ICE. CALLER REPORTED THAT THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND 475 CC OF FLUID WAS REMOVED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE EVENT OCCURRED DURING USE OF BIOSENSE WEBSTER PRODUCTS. THE PATIENT HAD A KNOWN EFFUSION PRIOR TO BEING BROUGHT TO THE PROCEDURE ROOM. IT GREW OVER THE LENGTH OF THE PROCEDURE. THE OPINION OF THE PHYSICIAN IS THAT THE CAUS

  Patient problems: Cardiac Tamponade

  MAUDE report 10658982 ↗
• MalfunctionApr 16, 2020Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB IDENTIFIED A HOLE ON THE PEBAX. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT WHEN THE CASE WAS CONCLUDED THE PHYSICIAN NOTICED BLOOD IN THE SPRING COMPONENT. ADDITIONAL INFORMATION RECEIVED INDICATES THEY COULD NOT TELL IF THERE WAS PHYSICAL DAMAGE TO THE CATHETER BUT CONFIRMED THERE WERE NO WIRES EXPOSED. THERE WAS NO DIFFICULTY EXPERIENCED WHEN MANEUVERING OR WITHDRAWING THE CATHETER FROM THE PATIENT AND A 8.5 F AGILIS MEDIUM CURL SHEATH WAS USED. AS SUCH, BASED ON THE INFORMATION AVAILABLE, THE CUSTOMER¿S EVENT WAS ASSESSED AS NOT MDR REPORTABLE SINCE THE FOREIGN MATERIAL WAS FOUND UNDERNEATH THE PEBAX AND THERE WAS NO DAMAGE TO THE PEBAX INTEGRITY. ON 2/26/2020, THE COMPLAINT PRODUCT WAS RECEIVED FOR EVALUATION. INITIAL VISUAL INSPECTION FOUND A DARK COLOR IS IN THE PEBAX. THIS WAS CONSIDERED TO BE NOT REPORTABLE. ON 3/24/2020, DURING FURTHER PRODUCT EVALUATION, A SCANNING ELECTRON MICROSCOPE (SEM) ANALYSIS WAS PERFORMED. SEM FOUND SHOWED EVIDENCE OF MECHANICAL DAMAGE A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9968755 ↗
• InjuryMar 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT ATRIAL FIBRILLATION ABLATION PROCEDURE WITH THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. IT WAS REPORTED DURING AN ATRIAL FIBRILLATION CASE, A CARDIAC PERFORATION WAS NOTICED. CALLER REPORTED THERE WAS A DROP IN BLOOD PRESSURE WITH THE PATIENT. THE CARDIAC PERFORATION WAS CONFIRMED BY INTRACARDIAC ECHOCARDIOGRAPHY (ICE). CALLER REPORTED THAT THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND IT IS UNKNOWN EXACTLY HOW MUCH FLUID WAS REMOVED, BUT THE CALLER REPORTED THAT IT WAS ABOUT 7 SYRINGES. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. SHOULD MORE INFORMATION BECOMES AVAILABLE IN THE FUTURE; THE REPORTABILITY DECISION WILL BE REASSESSED.

  Patient problems: Cardiac Tamponade

  MAUDE report 9821928 ↗
• InjuryDec 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION (STSF) CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING SURGICAL INTERVENTION. DURING THE PROCEDURE, AFTER MAPPING THE LEFT ATRIUM WITH THE LASSO CATHETER, THE PATIENT¿S BLOOD PRESSURE DROPPED. A CARDIAC TAMPONADE WAS THEN CONFIRMED BY INTRACARDIAC ECHOCARDIOGRAM. A PERICARDIOCENTESIS WAS PERFORMED AND OVER 1500 CC OF FLUID WAS REMOVED. HOWEVER, THE PATIENT WAS STILL BLEEDING. THE PATIENT WAS THEN TAKEN INTO CARDIOTHORACIC SURGERY TO SEAL THE PUNCTURE. IT WAS CONFIRMED THAT THE PERFORATION WAS IN THE RIGHT ATRIAL APPENDAGE, CAUSED BY A SL1 SHEATH, AND NOT A BIOSENSE WEBSTER INC. PRODUCT. POST PROCEDURE, THE PATIENT WAS REPORTED TO BE STABLE AND IMPROVED CONDITION. EXTENDED HOSPITALIZATION WAS REQUIRED FOR OBSERVATION, SINCE THE PATIENT UNDERWENT SURGERY. PHYSICIAN¿S OPINION ON THE CAUSE OF THE EVENT IS THAT IT IS PROCEDURE RELATED. A TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A SL1 SHEATH AND BAYLIS NEEDLE. DURING THE EVENT THE SOUND STAR AND STSF CATHETERS WERE IN THE PATIENT BODY. HOWEVER, NO ABLATION WAS PERFORMED PRIOR TO DISCOVERING THE CARDIAC TAM

  Patient problems: Cardiac Tamponade; No Code Available

  MAUDE report 9490976 ↗
• InjurySep 23, 2019Adverse 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 IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE ABLATION PHASE, A STEAM POP OCCURRED, AND THERE WAS A DROP-IN PATIENT¿S BLOOD PRESSURE. CARDIAC TAMPONADE WAS CONFIRMED BY ULTRASOUND. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 1000 CC OF FLUID FROM THE PERICARDIAL SPACE. THE PATIENT WAS REPORTED IN STABLE CONDITION AFTER PERICARDIAL DRAINAGE. EXTENDED HOSPITALIZATION WAS REQUIRED FOR OBSERVATION PURPOSES. PATIENT¿S OUTCOME WAS FULLY RECOVERED WITH NO RESIDUAL EFFECTS. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED. TRANSSEPTAL PUNCTURE WAS NOT PERFORMED DURING THE CASE. THE FLOW WAS SET AT 15CC/MIN. NO ERROR MESSAGES WERE OBSERVED ON ANY BIOSENSE WEBSTER INC. EQUIPMENT. THE FORCE VISUALIZATION FEATURES USED INCLUDED DASHBOARD AND VECTOR. THE PARAMETERS FOR STABILITY USED WITH THE VISITAG MODULE WERE 3 MM FOR 3 SECS AND TAG SIZE: 3. NO ADDITIONAL FILTERS WERE USED. THE COLOR OPTION USED PROSPECTIVELY WAS TIME.

  Patient problems: Cardiac Tamponade

  MAUDE report 9107901 ↗
• InjuryAug 14, 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® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE ABLATION PHASE, WHILE ABLATING AT 50 WATTS AROUND THE RIGHT SUPERIOR PULMONARY VEIN, A STEAM POP OCCURRED, AND THE PATIENT¿S BLOOD PRESSURE DROPPED. CARDIAC TAMPONADE WAS CONFIRMED BY INTRACARDIAC ECHO (ICE). PERICARDIOCENTESIS WAS PERFORMED, AND AROUND 2 LITERS OF FLUID WERE REMOVED FROM THE PERICARDIUM. IT IS UNKNOWN IF EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. PHYSICIAN¿S CAUSALITY OPINION IS UNKNOWN. THERE WERE NO ISSUES, ERRORS OR MALFUNCTIONS REPORTED IN ANY BWI PRODUCT DURING THE PROCEDURE. IT IS UNKNOWN IF TRANSSEPTAL PUNCTURE WAS PERFORMED. THE PHYSICIAN ABLATED AT 50 WATTS. IT IS NOT KNOWN IF THE PATIENT RECEIVED ANTICOAGULANT DURING THE PROCEDURE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GAIN CLARIFICATION ON THIS EVENT WITH NO RESPONSE.

  Patient problems: Cardiac Tamponade

  MAUDE report 7782411 ↗
• MalfunctionDec 28, 2016Break; Hole In Material; Material Protrusion/Extrusion; Scratched Material

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL SMART TOUCH BIDIRECTIONAL SF CATHETER WHERE THE TIP BROKE AND FILLED WITH BLOOD. THE DAMAGE DID NOT RESULT IN ANY LIFTED/SHARP RINGS, NOR ANY EXPOSED WIRING. THERE WAS NO DETACHMENT OF CATHETER COMPONENTS, AND NO DIFFICULTY WAS NOTED DURING INSERTION OR REMOVAL OF THE CATHETER. THE CATHETER WAS REPLACED, AND THE CASE CONTINUED WITHOUT ANY REPORT OF PATIENT CONSEQUENCE. BLOOD IS AN EXPECTED FINDING AFTER THIS TYPE OF PROCEDURE, AND IS NOT MDR REPORTABLE. SINCE THERE WERE NO LIFTED/SHARP RINGS, NO EXPOSED WIRING, THIS EVENT WAS NOT CONSIDERED MDR REPORTABLE. ON (B)(6) 2016, THE BIOSENSE WEBSTER FAILURE ANALYSIS LAB NOTED A BREAK IN TRANSITION BETWEEN THE SPINE COVER AND TIP OF THE CATHETER. HOWEVER, THE CATHETER INTEGRITY WAS MAINTAINED, AND NO INTERNAL COMPONENTS WERE FOUND TO BE EXPOSED. THIS WAS ALSO NOT CONSIDERED AN MDR REPORTABLE FINDING. ALSO ON (B)(6) 2016, THE CATHETER UNDERWENT SCANNING ELECTRON MICROSCOPE ANALYSIS, WHERE IT WAS FOUND THAT THE PEBAX EXHIBITED EVIDENCE OF SCRATCHES AND PINHOLES. THIS EXPOSES THE PATIENT TO THE INTERNAL COMPONENTS OF THE CATHETER, CREATING

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6211051 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P030031. 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-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-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-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-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-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