QDOT MICRO D139401Recalls & reported problems

Summary

The FDA's MAUDE database contains 114 adverse event reports that list this exact device (DI 10846835017045), received between Aug 11, 2023 and Sep 24, 2026 — classified as 2 deaths, 33 injuries, 79 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (33 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 114 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Patient Device Interaction Problem

  It was reported that a patient underwent a cardiac ablation procedure with a QDOT MICRO Catheter and the patient experienced heart block.In the Kent¿s bundle on septum procedure, an atrioventricular (AV) block occurred during around the fourth ablation from the aorta. The ablation time was about seven seconds at 20W. The patient had not progressed to a complete AV block. Since it was not a complete block, the patient was awakened and was placed under observation. The patient required prolonged hospitalization.Physician assessment of the health problem is non-serious (moderate/minor). The physician's opinion on the relationship between the event and the product is that the physician considered the issue unrelated to the product. There were no abnormalities observed prior to or during use of the product.

  Patient problems: Heart Block

  MAUDE report 50889246 ↗
• InjurySep 24, 2026Patient Device Interaction Problem

  It was reported that during a clinical study, the patient received index cardiac ablation on (b)(6) 2026 for ischemic ventricular tachycardia. On (b)(6) 2026, patient experienced left atrial appendage thrombus (AE#1) categorized as moderate and not serious. Relationship to study device is not related and relationship to the index study procedure is possible. The outcome is ongoing. Intervention was medication (apixaban).

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50877529 ↗
• MalfunctionApr 2, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION AFIB: PAROXYSMAL ABLATION PROCEDURE, AND WHEN THEY CAME ON ABLATION WITH THE QDOT MICRO¿ CATHETER, THE FORCE READINGS INCREASED (JUMPED UP) MULTIPLE TIMES. THERE WERE NO ERRORS DISPLAYED. THE CABLE WAS REPLACED WITHOUT RESOLUTION. WHEN THE CATHETER WAS REPLACED, THE ISSUE RESOLVED. THE REPORTER NOTED THAT IT WAS A BRAND-NEW CATHETER. THE PROCEDURE CONTINUED WITH NO FURTHER ISSUES. 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 AND SCREENING TEST OF THE RETURNED DEVICE WERE PERFORMED. VISUAL ANALYSIS REVEALED REDDISH MATERIAL INSIDE THE PEBAX AND A SEPARATION BETWEEN ELECTRODE AND PEBAX. THIS FINDING IS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24762324 ↗
• InjuryMar 17, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A QDOT MICRO AND THE PATIENT EXPERIENCED STROKE LIKE SYMPTOMS REQUIRING PROLONGED HOSPITALIZATION. AFTER DOING A LEFT ATRIUM PROCEDURE WITH THE PATIENT IN GENERAL ANESTHESIA, THE PATIENT WAS SHOWING SYMPTOMS OF A STROKE WHILE IN THE LAB JUST AFTER THE PROCEDURE WAS DONE. THE PATIENT WAS SENT FOR AN ACUTE COMPUTED TOMOGRAPHY (CT) CEREBRUM SCAN WHICH SHOWED NO SIGNS OF BLEEDING OR THROMBOSIS/EMBOLISM. PATIENT FULLY RECOVERED AND DISCHARGED THE DAY AFTER (THE PATIENT REQUIRED EXTENDED HOSPITALIZATION FOR OBSERVATION). ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PHYSICIAN DIDN¿T SUSPECT ANY BWI PRODUCT MALFUNCTION. OTHER THAN THAT, SHE SUSPECTED A NUMBER OF REASONS FOR THE STROKE-LIKE SYMPTOMS INCLUDING LOW BLOOD PRESSURE DURING ANESTHESIA, SLOW WAKEUP AFTER BEING IN GENERAL ANESTHESIA FOR THREE HOURS, SMALL AIR BUBBLE DURING FLUSH ON THE TWO SHEATHS, THAT SHE WAS USING. ACTIVATED CLOTTING TIME (ACT) WAS ABOVE 300.

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 24624311 ↗
• InjuryMar 4, 2026Patient Device Interaction Problem

  DURING A CLINICAL TRIAL IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRICULAR TACHYCARDIA PROCEDURE WITH A QDOT MICRO CATHETER AND AN OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND SUFFERED A PERICARDIAL EFFUSION WHICH REQUIRED PROLONGED HOSPITALIZATION. PATIENT RECEIVED AN INDEX VENTRICULAR TACHYCARDIA CARDIAC ABLATION ON (B)(6) 2026. ON (B)(6) 2026 START DATE AND SITE AWARENESS DATE OF 06-FEB-2026, THE PATIENT EXPERIENCED PERICARDIAL EFFUSION WITHOUT HEMODYNAMIC RELEVANCE AFTER THE ABLATION PROCEDURE WITH A QDOT MICRO CATHETER CATEGORIZED AS MODERATE AND SERIOUS DEFINED BY IN PATIENT/PROLONGED HOSPITALIZATION WITH AN ADMISSION DATE OF (B)(6) 2026 AND DISCHARGED DATE OF (B)(6) 2026. RELATIONSHIP TO STUDY DEVICES (QDOT MICRO AND OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY) WAS PROBABLE AND NOT RELATED TO ALL OTHER DEVICES. THE RELATIONSHIP WITH THE INDEX STUDY PROCEDURE IS CAUSAL AND EXPECTED/ANTICIPATED. THE OUTCOME IS RESOLVED WITH AN END DATE OF (B)(6) 2026 WITH NO INTERVENTION NOTED. THE DATE THE EVENT IS FIRST REPORTED TO BE AN SERIOUS ADVERSE EVENT (SAE) IS 06-FEB-2026.

  Patient problems: Cardiac Tamponade

  MAUDE report 24508391 ↗
• InjuryFeb 18, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A BWI-SPONSORED CLINICAL STUDY A PATIENT UNDERWENT AN INDEX CARDIAC ABLATION WITH A QDOT MICRO CATHETER AND EXPERIENCED PLEURAL EFFUSION POST-ABLATION. THE ISSUE WAS CATEGORIZED AS MODERATE AND SERIOUS WITH PROLONGED HOSPITALIZATION. THE PATIENT WAS ORIGINALLY ADMITTED ON (B)(6) 2025, HAD THEIR PROCEDURE ON (B)(6) 2025, AND WAS DISCHARGED ON (B)(6) 2025. IT WAS DETERMINED THAT THE EVENT WAS NOT RELATED TO THE QDOT MICRO CATHETER OR OTHER DEVICES USED. ADDITIONALLY, THE RELATIONSHIP BETWEEN THE PROCEDURE ITSELF AND THE EVENT IS THAT THE EFFUSION WAS A POSSIBILITY BUT THAT ITS OCCURRENCE WAS UNEXPECTED/UNANTICIPATED. THE PATIENT WAS TREATED WITH THE MEDICATION FUROSEMIDE, AND THEIR ISSUE WAS CONFIRMED TO BE RESOLVED BY (B)(6) 2026.

  Patient problems: Pericardial Effusion

  MAUDE report 24380596 ↗
• MalfunctionFeb 12, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PVI ABLATION PROCEDURE WITH A QDOT MICRO CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE IN THE SURFACE OF THE PEBAX. THE PATIENT WAS PREPPED IN THE CENTERS USUAL FASHION FOR A PVI ABLATION. UPON THE PROPER CONNECTIONS OF THE QDOT MICRO CATHETER, IT WAS ADVANCED INTO THE LEFT ATRIUM AND THE FORCE WAS ZEROED. ON THE FIRST ABLATION, THE FORCE WOULD INCREASE TO HIGH AND THE PHYSICIAN WOULD GO OFF OF THE ABLATION. HEART RATE, RESPIRATION AND CATHETER POSITION DID NOT CONTRIBUTE TO HIGH FORCE UPON ABLATION. THIS CONTINUED FOR ANOTHER 2-3 ABLATIONS. TO TROUBLESHOOT, THE CABLE WAS EXCHANGED FOR A NEW ONE WITH NO RESOLUTION. FINALLY, THE QDOT MICRO CATHETER WAS EXCHANGED FOR A NEW ONE. ABLATION CONTINUED WITHOUT HIGH FORCE AND CASE CONTINUED TO COMPLETION WITHOUT ANY FURTHER DELAY. THE PROCEDURE WAS DELAYED 5 MINUTES DUE TO THE REPORTED ISSUE. NO PATIENT CONSEQUENCE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 16-JAN-2026, OBSERVED A HOLE IN THE SURFACE OF THE PEBAX AND REDDISH MATERIAL INSIDE. THE EVENT WAS ORIGINALLY CONSIDERED NON-REPO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324600 ↗
• DeathJan 23, 2026Adverse Event Without Identified Device or Use Problem

  DURING A BWI-SPONSORED CLINICAL STUDY, IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A QDOT MICRO CATHETER AND THE NEXT DAY THEY EXPERIENCED CARDIOGENIC SHOCK THAT THE MEDICAL TEAM CATEGORIZED AS SEVERE AND SERIOUS. THE PATIENT'S ORIGINAL PROCEDURE WAS ON (B)(6) 2025 AND THEIR HOSPITALIZATION LASTED UNTIL THEIR DEATH ON (B)(6) 2025. THE RELATIONSHIP WITH STUDY DEVICES IS NOT RELATED. THE RELATIONSHIP TO THE INDEX STUDY PROCEDURE IS PROBABLE AND EXPECTED/ANTICIPATED. THE PATIENT RECEIVED MEDICATIONS CONSISTING OF AMIODARONE, ATROPINE, AND LIDOCAINE. THE PATIENT UNDERWENT CARDIOVERSION, AND SURGERY WITH ECMELLA. LEADING TO THE PATIENT'S DEATH, THEY EXPERIENCED 11 DAYS OF NO NEUROLOGICAL IMPROVEMENT WITHOUT SEDATION, HEMODYNAMIC DETERIORATION, PROGRESSIVE MULTIPLE ORGAN FAILURE, MULTIPLE HEMORRHAGIC EVENTS, AND THERAPEUTIC OPTIONS EXHAUSTED.

  Patient problems: Cardiogenic Shock

  MAUDE report 24164901 ↗
• MalfunctionDec 17, 2025Signal Artifact/Noise; Impedance Problem; Signal Artifact/Noise; Impedance Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A QDOT MICRO FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE ON THE SURFACE OF THE PEBAX. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT DURING THE OPERATION, SIGNAL INTERFERENCE (NOISE) WAS OBSERVED ON INTRACARDIAC (IC) CHANNELS AND SEVERE INTERFERENCE WAS OBSERVED ON THE FIRST ELECTRODES. THERE WAS NO IMPEDANCE VALUE READING FROM THE DEVICE. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. ADDITIONAL "INFORMATION" WAS RECEIVED INDICATING THE ISSUE WAS OBSERVED ONLY ON INTRACARDIAC (IC) CHANNELS ON THE CARTO 3 SYSTEM ONLY. THE CATHETER WAS INSIDE THE PATIENT¿S BODY AT THE TIME OF INCIDENT. THE PHYSICIAN DID HAVE OTHER INTACT ECG SIGNAL AVAILABLE TO MONITOR THE PATIENT¿S HEART RHYTHM. THE CUSTOMER'S REPORTED NOISE INTERFERENCE 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 (B)(6) 2025, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND A HOLE IN THE SURFACE OF THE PEBAX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23835583 ↗
• MalfunctionNov 25, 2025Insufficient Cooling; Incorrect, Inadequate or Imprecise Result or Readings; Insufficient Cooling; Incorrect, Inadequate or Imprecise Result or Readings

  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 HOLE ON THE PEBAX. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT THEY PERFORMED A REDO PULMONARY VEIN ISOLATION (PVI). WHEN THEY STARTED IN QM+ AND THE ABLATION INDICATED HIGH FORCE IMMEDIATELY AND ABLATION WAS ABORTED BY NGEN WITH THE INFORMATION THAT THE TEMPERATURE GRADIENT WAS TOO HIGH BUT THE TEMPERATURE CUTOFF WAS NOT REACHED. NOTABLY, THE CONTACT PRESSURE WAS VERY HIGH, WHICH WAS UNLIKELY TO BE REAL. IN QM WITH 50W, THE ABLATION WORKS, BUT THE CONTACT PRESSURE IS STILL SIGNIFICANTLY TOO HIGH. THEY TRIED DIFFERENT POSITIONS FOR ABLATION. EXCHANGE OF CABLE DID NOT SOLVE THE PROBLEM. NEEDED TO EXCHANGE THE CATHETER TO FINISH THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE. TEMPERATURE CUT-OFF WAS NOT EXCEEDED. THERE WAS SOMETHING OFF WITH THE FORCE SENSOR, WHICH INDICATED REALLY HIGH FORCE UNDER ABLATION, WHICH WAS NOT REAL FOR SURE. WITH 50W ABLATION WAS PROCEEDED BUT STILL WITH HIGH FORCE. AFTER THE EXCHANGE OF CATHETER THE SYSTEM WAS WORKING PERFECTLY. THE CUSTOMER'S REPORTED HIGH TEMPERATURE AND FORCE ISSUES ARE NOT CO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23653377 ↗
• MalfunctionNov 18, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A QDOT MICRO AND AN IRRIGATION ISSUE OCCURRED DURING USE ON THE PATIENT. IT WAS REPORTED THAT AFTER ABLATION OF PULMONARY VEIN ISOLATION (PVI) WITH QMODE+, A SWITCH TO CAVOTRICUSPID ISHMUS (CTI) ABLATION WITH QMODE WAS NOT POSSIBLE AS THE CATHETER SEEMS TO BE CLOGGED AND WOULD NOT ABLATE. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS NO ERROR ON PUMP BUT, TEMPERATURE AND IMPEDANCE RISES RAPIDLY ON CATHETER DURING ABLATION AND ABLATION SESSION SHUTS OFF. THE CATHETER WAS REMOVED FROM PATIENT AND THEY TRIED FLUSHING IT, BUT NO WATER CAME OUT. THE CATHETER WAS REPLACED AND ISSUE RESOLVED. THERE WERE NO ISSUES WITH FLOW RATE CHANGE AT THE START OF ABLATION. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23589966 ↗
• InjuryOct 22, 2025Device Sensing Problem; Patient Device Interaction Problem; Device Sensing Problem; Patient Device Interaction Problem

  DURING A CAVOTRICUSPID ISTHMUS ABLATION (CTI) LINE ABLATION WITH A QDOT MICRO¿ CATHETER, THE PATIENT EXPERIENCED STEAM POP X4, SMALL IMPEDANCE RISE, AND AV (ATRIOVENTRICULAR) BLOCK. ABLATIONS WERE DONE WITH 50W. THE CATHETER, THE FLUSH, AND TEMPERATURES DURING ABLATIONS APPEARED "FINE". A SMALL IMPEDANCE RISE WAS NOTICED DURING THE ABLATIONS. A MERIT SHEATH WAS USED ALONG WITH A BOSTON SCIENTIFIC CS (CORONARY SINUS) CATHETER. NO OTHER DEVICES WERE USED. THE PROCEDURE WAS NOT SUCCESSFULLY COMPLETED.

  Patient problems: Heart Block

  MAUDE report 23363102 ↗
• MalfunctionSep 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  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 IN THE PEBAX. DURING THE PROCEDURE, HIGH FORCE OCCURRED ON THE START OF THE ABLATION. IT WAS NOT POSSIBLE TO ABLATE. THE CATHETER WAS REPLACED AND THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23098880 ↗
• InjuryAug 25, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING THE ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A QDOT MICRO CATHETER, THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT WAS TREATED WITH DRAIN PLACEMENT. IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, THE PATIENT STARTED TO SHOW SIGNS OF CARDIAC TAMPONADE. ULTRASOUND WAS PERFORMED AND CONFIRMED THE DIAGNOSIS. DRAIN WAS PLACED AND THE PERICARDIAL EFFUSION WAS EVACUATED. THE CONTINUED ABLATION WAS ABORTED. AFTER THE PATIENT LEFT THE LAB, THE PHYSICIAN IN CHARGE SAID HE SUSPECTED THE TAMPONADE HAPPENED DURING ABLATION, EVEN THOUGH NO CLEAR SIGNS OF THAT COULD BE SEEN ON THE RECORDED PARAMETERS. THE PROCEDURE WAS NOT SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PHYSICIAN¿S OPINION ON THE CAUSE OF THE CARDIAC TAMPONADE WAS THAT IT WAS CAUSED BY ABLATION CATHETER. THE OUTCOME OF THE ADVERSE EVENT WAS UNCHANGED. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION FOR ONE DAY EXTRA. THE PATIENT DID NOT REQUIRE CARDIAC SURGERY. THE PROCEDURAL ACTIVATED CLOTTING TIME (ACT) WAS WITHIN RECOMMENDED LEVELS. NO CATHETER EXCHANGES OCCURRED DURING THE PROCEDURE. TWO TRANSSEPTAL PUNCTURE SITES WERE PERFORMED DU

  Patient problems: Cardiac Tamponade

  MAUDE report 22891930 ↗
• MalfunctionJul 30, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION - PAROXYSMAL ABLATION PROCEDURE WITH A QDOT MICRO¿ CATHETER AND THE GENERATOR WAS NOT DELIVERING THE SET ENERGY. THE CATHETER WAS PULLED OUT OF THE PATIENT AND IT APPEARED THAT IT WAS NOT IRRIGATING NORMALLY. THE CORRECT CATHETER AND GENERATOR SETTINGS WERE SELECTED. THERE WERE NO ALERTS OR ERROR CODES NOTED. THE IRRIGATION WAS SET ON HIGH BUT THE CATHETER WAS BARELY DRIPPING. CATHETER CHANGE SOLVED THE PROBLEM. THERE WAS A 7-MINUTE DELAY PRIOR TO THE REPLACEMENT OF THE CATHETER. NO CATHETER FRAGMENTS WERE GENERATED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22662186 ↗
• MalfunctionJun 30, 2025Signal Artifact/Noise; Contamination /Decontamination Problem; Signal Artifact/Noise; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A QDOT MICRO FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A SEPARATION BETWEEN THE PEBAX AND THE ELECTRODE SECTION. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT DURING THE OPERATION, BLOOD LEAKAGE WAS FOUND IN THE CATHETER AS THERE IS A NOTICEABLE RED COLOR INSIDE THE CATHETER TIP. A SIGNAL INTERFERENCE (NOISE) WAS ALSO OBSERVED ON IC CHANNELS. SIGNAL INTERFERENCE OF MAP1-2/3-4 WAS OBSERVED ON THE CARTO 3 SYSTEM ONLY. A NEW CATHETER WAS USED TO COMPLETE THE SURGERY AND THERE WAS NO PATIENT INJURY REPORT. THE PHYSICIAN DID HAVE ANOTHER ECG SIGNAL AVAILABLE TO MONITOR PATIENT HEART RHYTHM. THE CUSTOMER'S REPORTED NOISE 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 4-JUN-2025, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND A SEPARATION BETWEEN THE PEBAX AND THE ELECTRODE SECTION. THESE FINDINGS WERE REVIEWED AND ASSESSED THE ISSUE OF THE ¿SEPARATION¿ AS AN MDR REPORTABLE MALFUNCTION SINCE THE INTEGRITY OF THE DEVIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22359633 ↗
• MalfunctionJun 27, 2025Insufficient Cooling; Insufficient Cooling

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REDO PULMONARY VEIN ISOLATION PROCEDURE WITH A QDOT MICRO FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE ON THE SURFACE OF THE PEBAX SECTION. INITIALLY, IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE PHYSICIAN TRIED TO ABLATE WITH THE QDOT, THE TEMPERATURE VALUES WERE INCREASING RAPIDLY, ABLATION WAS AUTOMATICALLY SHUT OFF AND A ¿TEMPERATURE SLOPE TOO HIGH¿ ERROR MESSAGE WAS SHOWN ON THE NGEN GENERATOR. IRRIGATION AND PUMP WERE CHECKED AND FOUND TO BE CORRECT. REPLACING THE CATHETER CABLE DID NOT SOLVE THE PROBLEM. REPLACING THE CATHETER SOLVED THE ISSUE. PROCEDURE COMPLETED WITHOUT ANY PATIENT CONSEQUENCE. THE HIGH TEMPERATURE ISSUE WAS ASSESSED AS NON MDR REPORTABLE. THE RISK OF PATIENT HARM IS CONSIDERED REMOTE. THE BIOSENSE WEBSTER, INC. PAL RECEIVED THE DEVICE AND PER THE EVALUATION COMPLETION, A HOLE WAS OBSERVED ON THE PEBAX SURFACE WITH REDDISH MATERIAL INSIDE. THIS WAS ASSESSED AS MDR REPORTABLE WITH AN AWARENESS DATE OF 04-JUN-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22352247 ↗
• MalfunctionJun 26, 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 PROCEDURE WITH A QDOT MICRO FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A REDDISH MATERIAL AND A HOLE IN THE SURFACE OF THE PEBAX. INITIALLY, IT WAS REPORTED THAT WHEN STARTING WITH ABLATION (QDOT) IN A FLUTTER PROCEDURE, THE FORCE WOULD RISE HIGH, AS SOON AS ABLATION WAS STARTED, WITHOUT ANYTHING THAT SHOWED THAT THIS WAS REALLY THE CASE. THEY REPLACED THE CABLE AND DONGLE. HOWEVER, THIS DID NOT RESOLVE THE ISSUE. WHEN THEY CHANGED THE CATHETER, THE ISSUE WAS RESOLVED. WHEN PULLING OUT THE CATHETER, THERE WAS SOME BLOOD OBSERVED INSIDE THE FORCE SENSOR. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. THE FORCE ISSUE AND FOREIGN MATERIAL (BLOOD) WERE ASSESSED AS NON MDR REPORTABLE. THE RISK OF PATIENT HARM IS CONSIDERED REMOTE. THE BIOSENSE WEBSTER, INC. PAL RECEIVED THE DEVICE AND PER THE EVALUATION COMPLETION ON 03-JUN-2025, A HOLE WAS OBSERVED ON THE PEBAX SURFACE WITH REDDISH MATERIAL INSIDE. THIS WAS ASSESSED AS MDR REPORTABLE WITH AN AWARENESS DATE OF 03-JUN-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22342923 ↗
• MalfunctionJun 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER (AFL) PROCEDURE WITH A QDOT MICRO FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE ON THE PEBAX SURFACE. DURING THE PROCEDURE WITH A CARTO3 V8 SYSTEM AND QDOT MICRO CATHETER, AT THE MOMENT THAT DOCTOR STARTED APPLYING RADIO FREQUENCY (RF), CONTACT FORCE INCREASED TO HIGH VALUES (80/90) SUDDENLY WITHOUT ANY MOVEMENT OF CATHETER. WHEN THE APPLICATION WAS TERMINATED, THE CONTACT FORCE HAD NORMAL VALUES (10/12). NO PATIENT CONSEQUENCE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 27-MAY-2025, OBSERVED REDDISH MATERIAL INSIDE THE PEBAX SLEEVE. DUE TO THIS CONDITION, THE DEVICE WAS INSPECTED UNDER MICROSCOPE AND A HOLE WAS FOUND ON THE PEBAX SURFACE. THE EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF A HOLE ON THE PEBAX SURFACE ON 27-MAY-2025 AND HAVE ASSESSED THIS RETURNED CONDITION AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292152 ↗
• MalfunctionJun 17, 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 PROCEDURE WITH A QDOT MICRO FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A SEPARATION BETWEEN PEBAX AND ELECTRODE WITH REDDISH MATERIAL INSIDE THE PEBAX. INITIALLY, IT WAS REPORTED THAT THEY USED THE QDOT CATHETER FOR THE ABLATION AND PERFORMED A RESET TO ZERO FOR THE FORCE SENSOR. THERE WAS NO ERROR MESSAGE ON CARTO. DURING THE ABLATION, THEY RECOGNIZED HIGH FORCE, RESET TO ZERO, AGAIN NO ERROR DEPICTED IN CARTO. HIGH FORCE REMAINED. WITHOUT TISSUE CONTACT, FORCE WAS ZERO BUT UNDER ABLATION / WITH TISSUE CONTACT FORCE WAS HIGH. AFTER THE PROCEDURE, THE PHYSICIAN NOTICED BLOOD AT THE TIP OF CATHETER WHERE THE FORCE SENSOR IS LOCATED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. THE FORCE ISSUE AND FOREIGN MATERIAL (BLOOD) WERE ASSESSED AS NON MDR REPORTABLE. THE RISK OF PATIENT HARM IS CONSIDERED REMOTE. THE BIOSENSE WEBSTER, INC. PAL RECEIVED THE DEVICE AND PER THE EVALUATION COMPLETION ON 21-MAY-2025, A SEPARATION BETWEEN PEBAX AND ELECTRODE WAS OBSERVED WITH REDDISH MATERIAL INSIDE. THIS WAS ASSESSED AS MDR REPORTABLE WITH AN AWARENESS DATE OF 21-MAY-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22238659 ↗
• InjuryJun 10, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE REPORT INDICATED THE DAY AFTER THE CARDIAC ABLATION WITH QDOT MICRO AND A VARIPULSE CATHETER AND THE PATIENT EXPERIENCED PARTIAL PARALYSIS AS THEY WERE UNABLE TO EXERT STRENGTH IN ONE LEG. THE PATIENT UNDERWENT MAGNETIC RESONANCE IMAGING (MRI) THAT SHOWED MULTIPLE CEREBRAL INFARCTIONS WERE IDENTIFIED IN THE OCCIPITAL LOBE REGION. THE MORNING FOLLOWING THE PROCEDURE, THE PATIENT EXHIBITED SYMPTOMS OF PARTIAL PARALYSIS AND WAS UNABLE TO EXERT STRENGTH IN ONE LEG. AFTER BEING TRANSPORTED TO ANOTHER HOSPITAL FOR AN MRI, MULTIPLE CEREBRAL INFARCTIONS WERE IDENTIFIED IN THE OCCIPITAL LOBE REGION. THE NOTIFICATION WAS RECEIVED FROM A CUSTOMER. IT WAS DECIDED THAT WE WOULD VISIT THE HOSPITAL TO APOLOGIZE FOR THE OCCURRENCE OF THE EVENT IN THE PROCEDURE USING VARIPULSE THROUGH COOPERATION WITH THE HEAD OFFICE AND UNDERSTANDING THE SITUATION. THE PHYSICIAN ASSESSMENT OF THE HEALTH PROBLEM WAS SERIOUS. NO PROLONGATION OF HOSPITALIZATION WAS REQUIRED. THE PHYSICIAN'S OPINIONS ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT WAS THIS IS THE FIRST OCCURRENCE OF COMPLICATION OF CEREBRAL INFARCTION IN A CASE USING A VARIPULSE CATHETER. IT IS LIKELY TO BE RELATED TO THE VARIPULSE CATHETER.

  Patient problems: Stroke/CVA

  MAUDE report 22176802 ↗
• MalfunctionJun 2, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A QDOT MICRO AND AT THE END OF THE PROCEDURE, THE DOCTOR NOTICED A LAYER OF PLASTIC AT THE END OF THE CATHETER, AS IF THE MATERIAL HAD MELTED ON THE CATHETER. THE IRRIGATION WORKED WELL. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22129111 ↗
• InjuryMay 29, 2025High Readings; Patient Device Interaction Problem; High Readings; Patient Device Interaction Problem

  THE REPORT INDICATED THAT DURING QDOT MICRO A RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) PROCEDURE WITH A QDOT CATHETER, THE PATIENT EXPERIENCED PERICARDIAL EFFUSION, AND PERICARDIAL DRAINAGE WAS PERFORMED. ALSO, THE IMPEDANCE VALUE INCREASED BY APPROXIMATELY 30O, TRIGGERING THE GENERATOR'S SAFETY FEATURES AND THE ABLATION WAS STOPPED. DURING RVOT ABLATION WITH THE QDOT MICRO CATHETER, THE IMPEDANCE VALUE INCREASED BY APPROXIMATELY 30O, TRIGGERING THE GENERATOR'S SAFETY FEATURES AND THE ABLATION WAS STOPPED. IMMEDIATELY AFTERWARD, AN ECHOCARDIOGRAM CONFIRMED THE PRESENCE OF PERICARDIAL EFFUSION, AND PERICARDIAL DRAINAGE WAS PERFORMED. THE PROCEDURE WAS CONCLUDED AS IT WAS. THE HEALTH PROBLEM WAS CARDIAC TAMPONADE, AND THERE WAS EXTENDED HOSPITAL STAY. CONTACT FORCE (CF) MONITORING METHODS USED WAS DASHBOARD, VECTOR, VISITAG, AND COLORING SETTING OF VISITAG WAS TAG INDEX. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THE PATIENT¿S CONDITION IMPROVED. THE PATIENT DID NOT REQUIRE CARDIAC SURGERY. ONE CATHETER EXCHANGE WAS USED. PRIOR TO NOTING THE PERICARDIAL EFFUSION, ABLATION WAS PERFORMED. RADIOFREQUENCY (RF) ENERGY WAS USED FOR ABLATION. THERE WAS NO ERROR MESSAGE OBSERVED

  Patient problems: Cardiac Tamponade

  MAUDE report 22106692 ↗
• InjuryMay 28, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A QDOT MICRO AND THE PATIENT EXPERIENCED DECREASED BLOOD PRESSURE, PERICARDIAL EFFUSION/CARDIAC TAMPONADE WHICH WAS TREATED WITH DRAINAGE. IMMEDIATELY AFTER THE SUPERIOR VENA CAVA (SVC) ISOLATION, A DECREASE IN BLOOD PRESSURE WAS NOTED, AND PERICARDIAL EFFUSION/CARDIAC TAMPONAGE WAS CONFIRMED. SINCE MILD ACCUMULATION OF EFFUSION WAS OBSERVED, DRAINAGE WAS PERFORMED. THE PROCEDURE WAS TERMINATED AFTER THE DRAINAGE. HEMOSTASIS WAS CONFIRMED THROUGH POSTOPERATIVE DRAINAGE, AND THE PATIENT LEFT THE ROOM. THE PHYSICIAN'S OPINIONS ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT WAS THAT DURING THE PROCEDURE, WHEN THE CATHETER WAS MOVED TOWARDS THE RIGHT ATRIAL APPENDAGE, THE CATHETER MIGHT HAVE PERFORATED THE CARDIAC WALL. PHYSICIAN ASSESSMENT OF THE ADVERSE WAS THAT IT WAS NON-SERIOUS (MODERATE/MINOR), AND NO EXTENDED DAIZATION. CONTACT FORCE (CF) MONITORING METHODS USED INCLUDED DASHBOARD, VECTOR, VISITAG, AND COLORING SETTING FOR VISITAG WAS FORCE TIME INTERVEL (FTI). NO ABNORMALITIES OBSERVED PRIOR/DURING USE OF THE PRODUCT. ADDITIONAL INFOMRATION RECEIVED INDICATED THE PHYSICIAN¿S OPINION ON THE CAUSE OF THI

  Patient problems: Cardiac Tamponade

  MAUDE report 22100438 ↗
• MalfunctionMay 28, 2025Contamination /Decontamination Problem; Contamination /Decontamination 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 THAT THE TIP WAS BROKEN AT THE TRANSITION WITH THE PEEK HOUSING. DURING THE PROCEDURE TOWARD THE END OF THE CASE, BLOOD WAS NOTICED INSIDE THE CLEAR TIP OF THE CATHETER. THE CASE WAS ABLE TO BE COMPLETED WITHOUT REPLACING THE CATHETER. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22097777 ↗