QDOT MICRO D139501Recalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 10846835016710), received between Aug 24, 2023 and Mar 18, 2026 — classified as 2 deaths, 29 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (29 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 73 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH A QDOT MICRO AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED DRAINAGE. AFTER THE PROCEDURE WAS COMPLETED THE BLOOD PRESSURE DECREASED AND IT WAS DETERMINED THAT PERICARDIAL EFFUSION HAD ACCUMULATED. DRAINAGE WAS PERFORMED. AFTER DRAINAGE WAS PERFORMED, MRI (MAGNETIC RESONANCE IMAGING) SUGGESTED THAT THERE WERE NO ISSUES. THE PATIENT LEFT THE ROOM, AND THE PATIENT¿S CONDITION IMPROVED. THE PHYSICIAN¿S ASSESSMENT OF HEALTH HAZARD WAS NOT SERIOUS (MODERATE/MILD), AND THE PHYSICIAN'S COMMENT ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT WAS NONE IN PARTICULAR. NO EXTENSION OF HOSPITALIZATION. THE DETAILS OF CLINICAL TESTS AND RESULT INDICATED NO THROMBUS WAS CONFIRMED ON MRI. THE PHYSICIAN BELIEVES THAT THE EVENT WAS MOST LIKELY PROCEDURE-RELATED. HE SUSPECTED THAT IT MAY HAVE OCCURRED EITHER WHEN THE BLOOD PRESSURE DROPPED DURING THE TRANSSEPTAL PUNCTURE OR WHEN HIGH CONTACT WITH THE POSTERIOR WALL WAS SHOWN.

  Patient problems: Cardiac Tamponade

  MAUDE report 24632126 ↗
• InjuryMar 2, 2026Patient Device Interaction Problem

  AFTER CARDIAC ABLATION WITH A VARIPULSE¿ BI-DIRECTIONAL CATHETER AND QDOT MICRO CATHETER, THE PATIENT EXPERIENCED A DECREASE IN BLOOD PRESSURE, PERICARDIAL EFFUSION, CARDIAC TAMPONADE, CARDIOGENIC SHOCK, AND THE PRESSURE CEASING COMPLETELY. THE PATIENT WAS TREATED WITH PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS) AND OPEN CHEST PROCEDURE WAS PERFORMED IN THE OPERATING ROOM. A PERFORATION IN THE LEFT ATRIAL APPENDAGE WAS TREATED DURING THE OPERATION. THE PCPS HAS NOW BEEN REMOVED, AND THE PATIENT'S CONDITION IS STABLE/IMPROVED. THE PATIENT WAS STILL IN THE HOSPITAL FOR POSTOPERATIVE OBSERVATION FOLLOWING THORACOTOMY (AS OF (B)(6) 2026). THE PHYSICIAN'S OPINION ON THE CAUSE OF THIS EVENT WAS THAT THE PERFORATION MAY HAVE OCCURRED WHEN ADDITIONAL ABLATION WITH THE QDOT MICRO CATHETER WAS PERFORMED FROM THE POSTERIOR WALL OF THE LPV (LEFT PULMONARY VEIN) TO THE ANTERIOR SIDE OF THE LSPV (LEFT SUPERIOR PULMONARY VEIN) AFTER ABLATION WITH THE VARIPULSE CATHETER. THE REPORT INDICATED THAT AFTER THE PROCEDURE WAS COMPLETED WITH A VARIPULSE AND QDOT CATHETERS, INTRA CARDIAC ECHO (ICE) DID NOT SHOW PERICARDIAL EFFUSION, BUT AFTER HEMOSTASIS AND JUST BEFORE THE PATIENT LEFT THE ROOM, BLOOD PRE

  Patient problems: Cardiac Arrest; Cardiac Perforation; Cardiogenic Shock

  MAUDE report 24485116 ↗
• InjuryFeb 27, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A CARDIAC ABLATION PROCEDURE WITH A QDOT MICRO CATHETER AND SUFFERED COMPLETE ATRIOVENTRICULAR BLOCK WHICH RESULTED IN A PACEMAKER IMPLANTATION. THE PATIENT EXPERIENCED A COMPLETE ATRIOVENTRICULAR BLOCK AFTER A CARDIAC ABLATION PROCEDURE. THERE WAS NO ERROR. ONLY GOOD PHARMACOVIGILANCE PRACTICES (GVP) REPORT WAS SUBMITTED. THERE WAS NO DEFECT IN THE BIOSENSE WEBSTER, INC. PRODUCTS. THE PHYSICIAN ASSESSMENT OF THE HEALTH HAZARD WAS NON-SERIOUS (MODERATE/MINOR). THE PHYSICIAN'S OPINIONS ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT WAS THAT THE CAUSE WAS UNKNOWN. IT WAS ALSO UNKNOWN WHETHER IT WAS RELATED TO THE PROCEDURE. NO EXTENDED HOSPITALIZATION WAS REPORTED. THE COLORING SETTINGS FOR VISITAG WAS TAG INDEX. THE VISITAG ADDITIONAL FILTER USED WAS FOT. NO ABNORMALITIES OBSERVED PRIOR/DURING USE OF THE PRODUCT. NGEN GENERATOR WAS USED FOR THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THE PATIENT DID NOT RECOVER FROM COMPLETE ATRIOVENTRICULAR BLOCK THE DAY AFTER THE PROCEDURE AND PACEMAKER IMPLANTATION WAS PERFORMED ON 05-FEB-2026. NGEN PUMP WAS USED FOR THE PROCEDURE.

  Patient problems: Heart Block

  MAUDE report 24473207 ↗
• MalfunctionJan 21, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTION (PVC) CARDIAC ABLATION PROCEDURE WITH A QDOT MICRO CATHETER AND AFTER INSERTING THE CATHETER INTO THE PATIENT'S BODY, BLOOD ENTERED THE CATHETER TIP. WIPING THE CATHETER COULD NOT REMOVE THE BLOOD. THE PHYSICIAN FOUND IT WHEN THE CATHETER WAS REMOVED FROM THE PATIENT¿S BODY. THE PRESENCE OF BLOOD PREVENTED A DETAILED EVALUATION OF WHETHER THE CATHETER PEBAX WAS DAMAGED. THERE WAS NO DIFFICULTY EXPERIENCED WHILE MANEUVERING THE CATHETER OR DURING CATHETER WITHDRAWAL. THE ISSUE WAS RESOLVED BY REPLACING THE CATHETER WITH A NEW ONE. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. THIS EVENT WAS ORIGINALLY ASSESSED AS NOT MDR REPORTABLE. THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION OF THE RETURNED DEVICE WAS PERFORMED. VISUAL INSPECTION REVEALED REDDISH MATERIAL AND A HOLE IN THE SURFACE OF THE PEBAX. THIS FINDING IS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24141426 ↗
• MalfunctionJan 20, 2026Insufficient Cooling

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A QDOT MICRO CATHETER AND POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB IDENTIFIED A HOLE ON THE SURFACE OF THE PEBAX. DURING THE PROCEDURE, A 'TEMPERATURE HIGH' ERROR OCCURRED AND ABLATION STOPPED. THIS OCCURRED DURING ABLATION OF THE POSTERIOR WALL OF THE LEFT ATRIUM. THE CATHETER WAS REPLACED AND THE PROCEDURE CONTINUED TO COMPLETION. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24120975 ↗
• MalfunctionNov 13, 2025Incorrect, Inadequate or Imprecise Result or Readings; Contamination /Decontamination Problem; Incorrect, Inadequate or Imprecise Result or Readings; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A QDOT MICRO CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A LIFTED ELECTRODE AT THE TIP AREA. AFTER INSERTED THE CATHETER INTO THE PATIENT'S BODY, AFTER ABLATED SEVERAL TIMES WHEN ABLATED AT SUPERIOR VENA CAVA (SVC), FORCE WAS INCREASED RIGHT AFTER ABLATING AND DISPLAY OF FORCE BECAME GRAY. THE SAME ISSUE OCCURRED WHEN ABLATED 3 OR 4 TIMES WITH CHANGING ABLATION AREA AND WATTS. AFTER THAT, WHEN CHECKED THE CATHETER, BLOOD HAD BEEN COLLECTED IN THE SPRING OF THE QDOT MICRO CATHETER. TIMING WAS 2 HOURS AFTER USING THE CATHETER, AT THE TIME OF SVC ABLATION. THE ISSUE WAS NOT RESOLVED BY REPLACING THE CABLE, BUT WAS RESOLVED BY REPLACING THE QDOT MICRO CATHETER. AFTER THAT, COMPLETED THE PROCEDURE SUCCESSFULLY AND WITHOUT PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED NO DIFFICULTY EXPERIENCED WHILE MANEUVERING THE CATHETER NOR DURING THE WITHDRAWAL. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 21-OCT-2025, OBSERVED REDDISH MATERIAL INSIDE THE PEBAX AND A LIFTED ELECTRODE AT THE TIP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23547814 ↗
• InjuryOct 15, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING A CARDIAC ABLATION PROCEDURE WITH A QDOT MICRO¿ CATHETER, THE PATIENT EXPERIENCED CARDIAC TAMPONADE TREATED WITH PERICARDIAL DRAINAGE. IT WAS REPORTED THAT AFTER BROCKENBROUGH, AFTER PRE-MAP AND SIX ABLATIONS. THE PHYSICIAN'S ASSESSMENT REGARDING THE HEALTH HAZARD WAS THAT THE EVENT WAS SERIOUS. THE PHYSICIAN¿S COMMENT WAS THAT IT IS CONSIDERED TO BE PERFORATION CAUSED BY BROCKENBROUGH, NOT RELATED TO CARTO3. EXTENSION OF HOSPITALIZATION WAS NOTED. THE CF (CONTACT FORCE) MONITORING METHODS WERE REAL-TIME GRAPH, DASHBOARD, VECTOR, AND VISITAG. VISITAG COLORING SETTING WAS TAG INDEX. NO ABNORMALITIES OBSERVED PRIOR/DURING USE OF THE PRODUCTS. AFTER CARDIAC TAMPONADE WAS CONFIRMED, ABLATION WAS PERFORMED USING QDOT MICRO CATHETER. BECAUSE THE BLOOD PRESSURE DECREASED GRADUALLY, AND PVI (PULMONARY VEIN ISOLATION) WOULD BE COMPLETED BY ABLATING A FEW POINTS OF GAPS AS THE PROCEDURE WAS AFTER CRYOABLATION, AND THE ABLATION WAS PERFORMED WITHOUT IMMEDIATE DRAINAGE. IT IS UNKNOWN WHETHER QDOT MICRO CATHETER AND OCTARAY WERE INSERTED INTO THE PATIENT¿S BODY BEFORE CONFIRMING THE CARDIAC TAMPONADE. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT THE CAUSE OF THE EV

  Patient problems: Cardiac Tamponade

  MAUDE report 23303225 ↗
• InjurySep 19, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  AFTER AN ATRIAL FIBRILLATION ABLATION WITH A QDOT CATHETER, THE PATIENT LEFT THE EP (ELECTROPHYSIOLOGY) ROOM AND EXPERIENCED PERICARDIAL EFFUSION TREATED WITH DRAINAGE AND ISSUE WAS RESOLVED. AFTER CONDUCTING AN ABLATION, THE PATIENT LEFT THE ROOM, AND A PERICARDIAL EFFUSION/CARDIAC TAMPONADE WAS CONFIRMED. ALTHOUGH THE PATIENT'S CONDITION WAS STABLE, DRAINAGE WAS PERFORMED, AND THE ISSUE WAS SHOWING SIGNS OF IMPROVEMENT/RESOLVED. THE PHYSICIAN'S JUDGMENT ON HEALTH HAZARD WAS NON-SERIOUS (MODERATE/MINOR). NO EXTENDED HOSPITALIZATION NOTED. THE PHYSICIAN'S OPINIONS ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT WAS THAT IT WAS UNKNOWN WHETHER CARTO 3 SYSTEM AND THE PRODUCTS WERE INVOLVED IN THIS ADVERSE EVENT. THE CF (CONTACT FORCE) MONITORING METHODS WERE DASHBOARD, VECTOR, AND VISITAG. THE VISITAG COLORING SETTINGS WAS TAG INDEX, AND THE VISITAG ADDITIONAL FILTERS USED WAS FOT (FORCE OVER TIME). NO ABNORMALITIES OBSERVED PRIOR/DURING USE OF THE PRODUCTS. SEPTAL PUNCTURE WAS PERFORMED WITH RF (RADIOFREQUENCY) NEEDLE. AN NGEN GENERATOR WAS USED. THE OUTCOME OF THE ADVERSE EVENT WAS IMPROVED. THE TRANSSEPTAL PUNCTURE WAS PERFORMED WITH RF (RADIOFREQUENCY) NEEDLE. PRIOR TO NOTI

  Patient problems: Cardiac Tamponade

  MAUDE report 23103047 ↗
• InjurySep 17, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING AN AFIB ABLATION WITH A QDOT MICRO¿ CATHETER, THE PATIENT EXPERIENCED GRADUAL WEAKENED PULSES AND CARDIAC TAMPONADE TREATED WITH DRAINAGE AND CARDIAC SURGERY FOR CARDIAC PERFORATION. AFTER THE CATHETER INSERTION AND CABLE CONNECTING THE QDOT MICRO CATHETER AND CABLE, ERRORS 105 AND 106 OCCURRED. ALTHOUGH CARTO3 RECOGNIZED THE QDOT, THE CATHETER WAS NOT DISPLAYED, AND ZERO COULD NOT BE OBTAINED. THE PROCEDURE CONTINUED WITH RECONNECTION AND CABLE REPLACEMENT BUT DID NOT RESOLVE THE ISSUE. THE MEDICAL TEAM REPLACED THE CATHETER WITH ANOTHER NEW ONE, WHICH RESOLVED THE ISSUE, AND THE PROCEDURE CONTINUED. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER PROBLEMS. ADDITIONAL INFORMATION INDICATED THAT WHILE THE CATHETER WAS NOT DISPLAYING PROPERLY AND WAS RAISED WITHOUT USING FLUOROSCOPY. THE CATHETER WAS INSERTED TOO DEEPLY, EXTENDING INTO THE LAA (LEFT ATRIAL APPENDAGE). IT WAS LATER NOTED THAT THE PULSES GRADUALLY WEAKENED, AND THE PROCEDURE WAS CHANGED FROM CARDIAC TAMPONADE, DRAINAGE, THEN OPEN CHEST SURGERY. AFTER CONFIRMING THE TAMPONADE, DRAINAGE WAS PERFORMED, BUT THE BLEEDING DID NOT STOP. DUE TO SUSPICION OF CARDIAC PERFORATION, THE DRAINAGE WAS MOVED OUT OF THE CARDIAC CAV

  Patient problems: Cardiac Perforation

  MAUDE report 23070586 ↗
• InjurySep 9, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A QDOT MICRO CATHETER AND THE PATIENT SUFFERED A CARDIAC TAMPONADE TREATED WITH DRAINAGE AND THE PATIENT RECOVERED. THE REPORT INDICATED THAT IN THE WARD, IMMEDIATELY AFTER THE PROCEDURE (1 HOUR), IT WAS CONFIRMED VIA INTRACARDIAC ECHO (ICE) CATHETER THAT THERE WAS NO PERICARDIAL EFFUSION. HOWEVER, DRAINAGE WAS PERFORMED, AND THE PATIENT RECOVERED. CARDIAC TAMPONADE WAS NOTED. THERE WAS NO PROLONGATION OF HOSPITAL STAY. CONTACT FORCE (CF) MONITORING METHOD INCLUDED VECTOR. COLORING SETTING USED WAS VISITAG WAS TAG INDEX. ADDITIONAL FILTER FOR VISITAG WAS FORCE OVER TIME (FOT). THE PHYSICIAN'S OPINIONS ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT WAS THAT THERE IS A POSSIBILITY THAT THE QDOT MICRO CATHETER MADE STRONG CONTACT WITH THE ATRIUM/ HEART WALL; IT IS POSSIBLE THAT IT HAS BEEN STRONGLY HIT BY THE CATHETER, NOT CAUTERIZED, BUT THIS WAS NOT DURING ABLATION. IT IS NOT CONSIDERED TO BE PRODUCT RELATED. NO ABNORMALITIES WERE OBSERVED PRIOR/DURING USE OF THE PRODUCT. THE OUTCOME OF THE ADVERSE EVENT WAS REPORTED AS FULLY RECOVERED (NO RESIDUAL EFFECTS). PRIOR TO NOTING THE CARDIAC TAMPONADE, ABLATION HAD ALREADY BEEN

  Patient problems: Cardiac Tamponade

  MAUDE report 23006588 ↗
• InjuryAug 28, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  AFTER COMPLETING A PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION PROCEDURE WITH A QDOT MICRO CATHETER, THE PATIENT EXPERIENCED AORTIC DISSECTION TREATED WITH SURGERY AND PROLONGED HOSPITALIZATION. THE REPORT INDICATED THAT THE PATIENT DEVELOPED AORTIC DISSECTION AFTER PVC PROCEDURE, THE APPROACH TO THE LEFT VENTRICLE (LV) MADE VIA THE AORTA AND ABLATION PERFORMED. AFTER THE LV MAPPING WITH OPTRELL, THE PATIENT BEGAN COMPLAINING OF LOWER BACK PAIN. THE MAPPING WAS PERFORMED AROUND THE LV AND THE CUSP AREA. WHILE THE PHYSICIAN WAS MONITORING THE PATIENT, THE PATIENT FELL ASLEEP. SUBSEQUENTLY, THE ABLATION TOOK PLACE AT THE UPPER PART OF THE LV USING QDOT MICRO CATHETER. NO ABLATION PERFORMED AT THE AORTA. THE PATIENT LEFT THE ROOM AFTER THE PVC TERMINATED BUT DEVELOPED THE AORTIC DISSECTION AND TRANSFERRED TO THE OPERATION ROOM. NO ISSUES WITH CARTO 3 SYSTEM OR THE CATHETERS, AND NO ABNORMAL BEHAVIOR OBSERVED WHEN PASSING THROUGH THE AORTA. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE AORTIC DISSECTION OCCURRED WITHIN ONE HOUR AFTER THE PROCEDURE. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION, HOWEVER, THE DURATION IS UNKNOWN. THE PHYSICIAN COMMENTED THAT THE CAUSE COULD NOT

  Patient problems: Aortic dissection

  MAUDE report 22914027 ↗
• InjuryJul 14, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED AFTER CARDIAC ABLATION PROCEDURE WITH A QDOT MICRO¿ CATHETER, THE PATIENT EXPERIENCED DROPPED BLOOD PRESSURE/CARDIAC TAMPONADE TREATED WITH PERICARDIAL DRAINAGE AND THORACOTOMY. THE ROOF SIDE ABLATION WAS STARTED USING QDOT CATHETER FROM LPV (LEFT PULMONARY VEIN) ISOLATION, AND LI (LEFT INFERIOR), CARINA, LSPV (LEFT SUPERIOR PULMONARY VEIN) WERE ABLATED. THEN, AT THE TIMING OF ROOF SIDE ABLATION, BLOOD PRESSURE DROPPED TO 70. SO, CONFIRMATION WAS MADE AS A PRECAUTION. THE PUNCTURE OF A CORONARY ARTERY (LAD) BY MISTAKE DURING PERICARDIAL DRAINAGE WAS CONSIDERED. AS THE BLOOD PRESSURE WAS MAINTAINED, THE PROCEDURE WAS CONTINUED, AND SIMULTANEOUS PREPARATIONS FOR PERICARDIAL DRAINAGE WERE MADE. A THORACOTOMY WAS PERFORMED, AND VITAL SIGNS WERE STABILIZED. THE PHYSICIAN¿S ASSESSMENT ON HEALTH HAZARD WAS SEVERE. THE PHYSICIAN¿S COMMENT ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT WAS THAT THE CONTACT FORCE WAS INCREASING DURING THE CATHETER MANIPULATION. EXTENSION OF HOSPITALIZATION PERIOD WAS NOTED. VISITAG COLORING SETTING USED WAS TAG INDEX, AND ADDITIONAL FILTER FOR VISITAG USED WAS FOT (FORCE OVER TIME). NO ABNORMALITIES OBSERVED PRIOR/DURING USE OF THE PRO

  Patient problems: Cardiac Tamponade

  MAUDE report 22500690 ↗
• DeathJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A VIZIGO AND A QDOT MICRO CATHETER. THE PATIENT EXPERIENCED ACCUMULATION OF BLOOD IN THE ABDOMEN TREATED WITH BLOOD TRANSFUSION FOR THE BLEED AND LATER THE PATIENT EXPERIENCED CARDIAC TAMPONADE AND EXPIRED TWO DAYS AFTER THE PROCEDURE. IT WAS INITIALLY REPORTED THAT AFTER THE PROCEDURE, AN ACCUMULATION OF BLOOD IN THE ABDOMEN WAS FOUND WHEN THE DRAPE WAS REMOVED. INTRACARDIAC WAS CHECKED BY ECHOCARDIOGRAPHY, AND NO PERICARDIAL EFFUSION WAS CONFIRMED. AFTER THE PATIENT LEFT THE PROCEDURE ROOM A BLOOD TRANSFUSION WAS PERFORMED. THE PHYSICIAN'S OPINION WAS THAT THERE WAS AN ISSUE WITH SOME ASPECT OF THE WORKFLOW DURING THE PUNCTURE BEFORE THE USE OF BWI PRODUCTS. ON (B)(6) 2025, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT IN ADDITION TO THE ABDOMINAL BLOOD ACCUMULATION OBSERVED IMMEDIATELY AFTER THE PROCEDURE, CARDIAC TAMPONADE WAS CONFIRMED AT A LATER DATE AND THE PATIENT PASSED AWAY IN THE HOSPITAL 2 DAYS AFTER THE INDEX PROCEDURE. THE DETAILS WERE UNCLEAR, BUT THE PHYSICIAN SUSPECTED THAT THE ISSUE OCCURRED DURING THE PUNCTURE PRIOR TO THE USE OF BWI DEVICES. THE PHYSICIAN'S ASSESSMENT OF THE HEALTH HAZAR

  Patient problems: Cardiac Tamponade

  MAUDE report 22452497 ↗
• InjuryJun 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE REPORT INDICATED DURING PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA ABLATION WITH QDOT MICRO¿ CATHETER, THE PATIENT EXPERIENCED THROMBOTIC CEREBRAL INFARCTION. THE PATIENT EXPERIENCED A THROMBOTIC CEREBRAL INFARCTION. THE PATIENT WAS NOT TAKING ANTICOAGULANTS. NO PROLONGATION OF HOSPITAL STAY OCCURRED. CAUSAL RELATIONSHIP WITH PRODUCT WAS UNKNOWN. DURING THE ABLATION OF THE SLOW PATHWAY WITH NAVISTAR CATHETER, THE TEMPERATURE RAMP BECAME ALARMINGLY GRADUAL. AFTER REPLACING IT WITH THE QDOT MICRO CATHETER, THE INCIDENT DID NOT RECUR, AND THE PROCEDURE WAS COMPLETED. INFORMATION RECEIVED INDICATED THAT THE SUBSEQUENT CONDITION OF THE PATIENT REMAINS UNKNOWN. THE PATIENT WAS NOT ORIGINALLY TAKING ANTICOAGULANTS AND HAD ONLY INSERTED THE CATHETER INTO THE RIGHT ATRIUM DURING THE PROCEDURE. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT THE PATIENT DID NOT TAKE ANTICOAGULANTS. NO FURTHER INFORMATION IS AVAILABLE. DELIVERED ENERGY WAS RF (RADIOFREQUENCY). INFORMATION RECEIVED INDICATING THAT THE TEMPERATURE ISSUE WAS FOUND DURING ABLATION WITH NAVISTAR. NO CELSIUS CATHETER.

  Patient problems: Ischemia Stroke

  MAUDE report 22355993 ↗
• InjuryJun 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA ABLATION, AND THE PATIENT EXPERIENCED CARDIAC BLOCK THAT REQUIRED A PLANNED PACEMAKER INSERTION. DURING ABLATION NEAR HIS, A COMPLETE CARDIAC BLOCK WAS CONFIRMED. A PACEMAKER IMPLANTATION WAS PLANNED. THE PHYSICIAN'S COMMENT ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT WAS THAT THE ABLATION NEAR HIS HAD BEEN PERFORMED TOO MUCH FOR A LONG TIME. THERE WERE NO ABNORMALITIES OBSERVED PRIOR TO OR DURING USE OF THE PRODUCT. CONTACT FORCE (CF) MONITORING METHOD USED WAS VECTOR AND VISITAG, VISITAG COLOR SETTING WAS TAG INDEX, AND ADDITIONAL VISITAG FILTER WAS FOT. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS PROCEDURE RELATED. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF PACEMAKER IMPLANTATION. NO RELEVANT TESTS/LABORATORY DATA OR OTHER RELEVANT HISTORY/PREEXISTING CONDITION WERE NOTED.

  Patient problems: Heart Block

  MAUDE report 22267193 ↗
• InjuryJun 2, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH A QDOT MICRO¿ CATHETER AND THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION THAT REQUIRED PERICARDIOCENTESIS AND SURGICAL INTERVENTION. DURING THE ABLATION OF LSPV (LEFT SUPERIOR PULMONARY VEIN, APPROXIMATELY 1 HOUR AFTER THE CATHETER WAS INSERTED INTO THE PATIENT'S BODY), THE PATIENT'S BLOOD PRESSURE GRADUALLY DECREASED. UPON ULTRASOUND EXAMINATION, PERICARDIAL EFFUSION WAS CONFIRMED. DRAINAGE WAS PERFORMED. DUE TO UNSTABLE BLOOD PRESSURE, A BLOOD TRANSFUSION WAS ADMINISTERED. THE PATIENT WAS TRANSPORTED BY AMBULANCE TO A NEARBY HOSPITAL, WHERE SURGICAL INTERVENTION WAS PLANNED. THE CAUSE IS UNDETERMINED. ACCORDING TO THE MAIN PHYSICIAN, THERE WAS A DIVERTICULUM NEAR THE LSPV, AND IT IS POSSIBLE THAT THE CATHETER MAY HAVE RUPTURED THE DIVERTICULUM UPON DISPLACEMENT. THERE WAS NO REFERENCE MADE TO A CAUSAL RELATIONSHIP WITH THE EP (ELECTROPHYSIOLOGY) DEVICE. NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE.

  Patient problems: Cardiac Perforation; Cardiac Tamponade

  MAUDE report 22126875 ↗
• MalfunctionApr 28, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A QDOT MICRO¿ CATHETER AND POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB IDENTIFIED A HOLE IN THE PEBAX. DURING THE PROCEDURE, THERE WAS A TEMPERATURE ABNORMALITY DURING ABLATION. THE ABLATION NEVER CONTINUED BEYOND THE CUT-OFF VALUE. REPLACED THE QDOT MICRO CATHETER TO ANOTHER NEW ONE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21921463 ↗
• InjuryApr 24, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AFTER THE CARDIAC ABLATION PROCEDURE WITH THE QDOT MICRO¿ CATHETER, THE PATIENT EXPERIENCED BLOOD PRESSURE DECREASED ASSOCIATED WITH CARDIAC TAMPONADE (CT) AND TREATED WITH PERICARDIAL PUNCTURE. THE REPORT INDICATED THAT AFTER THE PROCEDURE, THE PATIENT'S BLOOD PRESSURE DECREASED. UPON EXAMINATION BY THE PHYSICIAN, IT WAS DETERMINED TO BE CARDIAC TAMPONADE. PERICARDIAL PUNCTURE WAS PERFORMED, BUT THE BLOOD PRESSURE DID NOT STABILIZE, LEADING TO THE INTRODUCTION OF ECMO (EXTRACORPOREAL MEMBRANE OXYGENATION). NO ABNORMALITIES OBSERVED PRIOR/DURING USE OF THE PRODUCTS. INFORMATION RECEIVED INDICATED THAT THE PATIENT FULLY RECOVERED (NO RESIDUAL EFFECTS). ECMO WAS REMOVED SIX DAYS AFTER THE EVENT WAS REPORTED. PRIOR TO NOTING THE CT (COMPUTED TOMOGRAPHY) ABLATION WAS PERFORMED. NO PAST MEDICAL HISTORY WAS REPORTED. THE BLEEDING POINT WAS AT THE LEFT VENTRICLE (LV) SUMMIT. POSTOPERATIVE (CT) COMPUTERIZED TOMOGRAPHY SHOWED A HOLE SIZE OF APPROXIMATELY 12 MM. WHILE IT WAS NOT CLEAR IN THE SHORT AXIS ON THE ECHOCARDIOGRAM, IT WAS NOTED THAT THE MYOCARDIUM WAS NOT THIN. THE PATIENT WAS TREATED WITH DISINFECTED AND CLEANED. THE SITE TREATED/USE FOR WAS PREMATURE VENTRICU

  Patient problems: Cardiac Perforation

  MAUDE report 21903814 ↗
• MalfunctionApr 21, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A QDOT MICRO FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A SEPARATION BETWEEN THE PEBAX AND ELECTRODE AREA. THE CATHETER WAS NOT RECOGNIZED. TIMING OF CONNECTING THE CATHETER TO THE PATIENT INTERFACE UNIT (PIU). THE ISSUE WAS RESOLVED BY REPLACING THE QDOT MICRO CATHETER WITH ANOTHER NEW ONE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 27-MAR-2025 OBSERVED REDDISH MATERIAL IN THE TIP OF THE DEVICE. FURTHER EXAMINATION UNDER MICROSCOPIC IMAGING, A SEPARATION BETWEEN THE PEBAX AND ELECTRODE AREA WAS FOUND. THE EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF A SEPARATION BETWEEN THE PEBAX AND ELECTRODE AREA ON 27-MAR-2025 AND HAVE ASSESSED THIS RETURNED CONDITION AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876013 ↗
• InjuryApr 2, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH QDOT MICRO AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS AND PERCUTANEOUS CARDIOPULMONARY SUPPORT. IN THE ATRIAL FIBRILLATION SECOND PROCEDURE, GAP ABLATION FOR PULMONARY VEIN ISOLATION (PVI) AND NON-PULMONARY VEIN (PV) ABLATION WERE PERFORMED. THERE WAS A RECURRENCE IN THE LEFT INFERIOR PULMONARY VEIN (LIPV), AND THE LIPV GAP WAS ABLATED. NON-PV FIRING WAS ALSO CONFIRMED DUE TO PHARMACOLOGICAL STRESS AND ABLATION FOR THE ANTERIOR WALLS OF LEFT ATRIUM (LA) AND RIGHT ATRIUM (RA) WAS PERFORMED USING THE CSI TAG AS INDICATORS. AF WAS STOPPED AND CONSIDERED THE END POINT. AFTER THE PROCEDURE, PERICARDIAL FLUID WAS OBSERVED WITH ULTRASOUND, AND DRAINAGE WAS PERFORMED. THE DRAINAGE WAS SUCCESSFULLY COMPLETED. HOWEVER, BLOOD PRESSURE SUBSEQUENTLY DROPPED, AND THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU). THE HOSPITAL STAY WAS PROLONGED. ABLATION WAS PERFORMED PRIOR TO THE CARDIAC TAMPONADE IDENTIFIED. STEAM POP WAS NOT CONFIRMED. NO ABNORMALITIES WERE OBSERVED PRIOR TO OR DURING USE OF THE PRODUCT. SEPTAL PUNCTURE WAS PERFORMED WITH AN RF NEEDLE. ADDITIONAL INFORMATI

  Patient problems: Cardiac Tamponade

  MAUDE report 21755009 ↗
• InjuryMar 31, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. AFTER THE PROCEDURE, APPROXIMATELY 40 MINUTES AFTER THE PROCEDURE WAS COMPLETED, THE PATIENT'S BLOOD PRESSURE DECREASED. UPON EXAMINATION OF THE PERICARDIAL FLUID, A DIAGNOSIS OF CARDIAC TAMPONADE WAS MADE. DRAINAGE WAS PERFORMED. THE PATIENT WAS UNDER OBSERVATION IN THE WARD. PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION. THE PLAN WAS TO OBSERVE THE PATIENT THROUGH OUTPATIENT VISITS, AND THE PROCEDURE WILL BE PERFORMED AGAIN. THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT IS UNKNOWN. IN THIS CASE, THE ONLY DIFFERENCE FROM USUAL WAS THE USE OF A SHEATH FROM MEDIKIT INSTEAD OF THE TYPICALLY USED SL0 SHEATH. THE WIRE TOOK A CONSIDERABLE AMOUNT OF TIME TO EMERGE FROM THE TIP OF THE SHEATH, AND TRANSSEPTAL PUNCTURE WAS PERFORMED ABOUT THREE TIMES. NO ABNORMALITIES WERE OBSERVED PRIOR TO OR DURING USE OF THE PRODUCT. NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. NO EVIDENCE OF STEAM POP. NO ABLATION WAS PERFORMED PRIOR TO NOTING THE PERICARDIAL EFFUSION.

  Patient problems: Cardiac Tamponade

  MAUDE report 21734838 ↗
• InjuryMar 20, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION WITH A QDOT MICRO¿ CATHETER AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. AFTER THE PROCEDURE COMPLETION, THE CARDIAC TAMPONADE WAS FOUND WHEN THE PATIENT WAS IN THE HOSPITAL WARD. BLOOD PRESSURE DECREASE WAS CONFIRMED IN THE HOSPITAL WARD. THORACIC ECHOGRAPHY REVEALED PERICARDIAL EFFUSION, AND DRAINAGE WAS PERFORMED. AFTER THE DRAINAGE, THE PATIENT¿S CONDITIONS WERE STABILIZED. THE PATIENT WAS UNDER OBSERVATION. PATIENT FULLY RECOVERED AND REQUIRED EXTENDED HOSPITALIZATION FOR OBSERVATION. THE PHYSICIAN'S OPINION ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT WAS THAT THE CATHETER MIGHT HAVE BEEN PRESSED STRONGLY; HOWEVER, THE PHYSICIAN DID NOT CONSIDER THAT THE EVENT OCCURRED DURING THE ABLATION. NO ABNORMALITIES WERE OBSERVED PRIOR TO OR DURING USE OF THE PRODUCT. NO EVIDENCE OF STEAM POP. NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. THE PROCEDURAL ACT (ACTIVATED CLOTTING TIME) WAS OVER 300.

  Patient problems: Cardiac Tamponade

  MAUDE report 21657887 ↗
• InjuryMar 3, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION WITH A QDOT MICRO AND THE PATIENT EXPERIENCED HEART BLOCK THAT REQUIRED TEMPORARY PACEMAKER. CARDIAC BLOCK OCCURRED. THE PATIENT LEFT THE ROOM WITH A TEMPORARY PACEMAKER PLACED. NO EXTENDED HOSPITALIZATION. THERE IS A POSSIBILITY THAT THE CARDIAC BLOCK WAS CAUSED BY THE FINAL ABLATION. NO ABNORMALITIES WERE OBSERVED PRIOR TO OR DURING USE OF THE PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS PROCEDURE RELATED.

  Patient problems: Heart Block

  MAUDE report 21505731 ↗
• MalfunctionFeb 26, 2025Insufficient Cooling; Device Contamination with Body Fluid; Obstruction of Flow; Insufficient Cooling; Device Contamination with Body Fluid; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE WITH A QDOT MICRO¿ CATHETER AND TEMPERATURE TITRATION OCCURRED FREQUENTLY. THE ABLATION WAS STOPPED DUE TO THE TEMPERATURE ROSE. THIS OCCURRED AFTER APPROXIMATELY 80 ABLATIONS. FLUSHING WAS CONDUCTED, BUT THE CHAR WAS ATTACHED TO THE CATHETER AND COULD NOT BE REMOVED BY WIPING IT OFF BY HAND. THE ISSUE WAS RESOLVED BY REPLACING THE QDOT MICRO CATHETER. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21471752 ↗
• InjuryJan 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH A QDOT MICRO AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. AFTER PERFORMING PULMONARY VEIN ISOLATION (PVI), BOX AND CAVOTRICUSPID ISTHMUS (CTI) USING QDOT MICRO CATHETER AND LASSO 2515 NAV ECO CATHETER, CARDIAC TAMPONADE WAS CONFIRMED ON FLUOROSCOPY, AND THE PATIENT'S VITALS DECREASED. PERICARDIAL DRAINAGE WAS PERFORMED. AFTER PERFORMING DRAINAGE, THE PATIENT'S VITALS STABILIZED AND THE PATIENT RETURNED TO THE INTENSIVE CARE UNIT (ICU). THE PATIENT DID NOT REQUIRE PROLONGED HOSPITALIZATION. SEPTAL PUNCTURE WAS PERFORMED WITH A RF NEEDLE. NO ABNORMALITIES OBSERVED PRIOR TO USE OF THE DEVICE NOR DURING USE OF THE PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED ON 14-JAN-2025. NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. THE ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. PATIENT IMPROVED. ADDITIONAL INFORMATION WAS RECEIVED ON 21-JAN-2025. ACT WAS AROUND 300. ONE TRANSSEPTAL PUNCTURE SITE WAS PERFORMED DURING THE PROCEDURE. NO EVIDENCE OF STEAM POP.

  Patient problems: Cardiac Tamponade

  MAUDE report 21274190 ↗