QDOT MICRO D139402Recalls & reported problems

Summary

The FDA's MAUDE database contains 171 adverse event reports that list this exact device (DI 10846835017076), received between Aug 1, 2023 and Sep 30, 2026 — classified as 3 deaths, 31 injuries, 137 malfunctions.

The most frequently reported specific device problem is “Coagulation in Device or Device Ingredient” (73 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 171 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Obstruction of Flow; Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50955040 ↗
• MalfunctionSep 23, 2026Insufficient Cooling

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50875925 ↗
• MalfunctionMar 4, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER LEFT (L-AFL) PROCEDURE WITH A QDOT MICRO CATHETER AND AN IRRIGATION ISSUE (DEVICE USED IN PATIENT) ISSUE WAS OBSERVED. THE QDOT MICRO CATHETER WAS FLUSHED BEFORE INSERTION INTO THE PATIENT, WHICH WORKED WITHOUT ANY PROBLEMS. THE CATHETER WAS INSERTED INTO THE PATIENT AT A CONTINUOUS FLUSH RATE OF 2 ML/H. ZERO ADJUSTMENT WAS SUCCESSFUL. THE CATHETER WAS PLACED IN THE ABLATION REGION AND A MESSAGE APPEARED ON THE NGEN "TEMPERATURE TOO HIGH". THE CATHETER WAS REMOVED FROM THE PATIENT AGAIN. ATTEMPTED TO FLUSH THE CATHETER. CATHETER COULD NO LONGER BE FLUSHED. MANUAL MANIPULATION ATTEMPTED WITH SYRINGE OUTSIDE THE PATIENT WITHOUT SUCCESS. PRODUCT REPLACED AND NEW PRODUCT WORKED PERFECTLY. PROCEDURE PERFORMED SUCCESSFULLY WITHOUT CONSEQUENCES FOR THE PATIENT. THE PROCEDURE WAS NOT DELAYED DUE TO THE REPORTED ISSUE. ADDITIONAL INFORMATION WAS RECEIVED. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. NO ABLATION TOOK PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24509436 ↗
• MalfunctionFeb 13, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PULMONARY VEIN ISOLATION (PVI) CARDIAC ABLATION PROCEDURE WITH A QDOT MICRO CATHETER. AFTER CHANGING FROM QDOT TO PENTARAY FOR DOING A REMAP IN PVI PROCEDURE, THE PHYSICIAN NOTICED THAT BLOOD LEAKED INTO THE QDOT AND AROUND THE FORCE SENSOR. THERE WAS NO DIFFICULTY EXPERIENCED WHILE MANEUVERING THE CATHETER OR DURING THE WITHDRAWAL. THEY DID NOT NOTICE THE CATHETER PEBAX TO BE BROKEN NOR CRACKED. THEY ONLY NOTICED BLOOD INSIDE. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT HARM. 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, VISUAL INSPECTION OF THE RETURNED DEVICE WAS PERFORMED. VISUAL ANALYSIS REVEALED A HOLE IN THE SURFACE OF THE PEBAX AND REDDISH MATERIAL INSIDE. THIS FINDING IS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24334120 ↗
• InjuryFeb 12, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE WITH A QDOT MICRO CATHETER AND SUFFERED A CARDIAC TAMPONADE WHICH REQUIRED A PERICARDIAL DRAINAGE AND TRANSFERRED TO THE INTENSIVE CARE. THE REPORT INDICATED THAT AT THE END OF THE PROCEDURE, NO PERICARDIAL EFFUSION WAS OBSERVED. A FEW DAYS LATER, THE PATIENT DEVELOPED CARDIAC TAMPONADE SECONDARY TO A PERICARDIAL EFFUSION. PERICARDIAL DRAINAGE WAS PERFORMED (150 ML OF BLOOD) USING X-RAY TO GUIDE THE PHYSICIAN, AND THE PATIENT WAS TRANSFERRED TO INTENSIVE CARE FOR MONITORING. RADIOFREQUENCY (RF) ENERGY WAS DELIVERED AT 50 W USING NGEN GENERATOR IN TEMPERATURE-CONTROLLED MODE. RETROSPECTIVE ANALYSIS ALLOWED FOR THE RE-EVALUATION OF RF APPLICATION TO THE ANTERIOR ASPECT OF THE LEFT SUPERIOR PULMONARY VEIN WITH A TRANSIENT CONTACT FORCE APPROACHING 100G FOR 2 SECONDS AT THE END OF THE APPLICATION. THIS APPLICATION WAS ASSOCIATED WITH A SIGNIFICANT IMPEDANCE DROP GREATER THAN 15OHMS. THE PROCEDURE WAS PERFORMED WITH HEPARIN PRIOR TO TRANSSEPTAL PUNCTURE, WITHOUT COMPLICATIONS AT THAT TIME. THE PATIENT REQUIRED REVISION SURGERY ON (B)(6) 2026 FOR THE PERICARDIAL EFFUSION. MULTIPLE ATTEMPTS HAVE BEEN MADE

  Patient problems: Cardiac Tamponade

  MAUDE report 24322915 ↗
• InjuryFeb 4, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) CARDIAC ABLATION PROCEDURE WITH A QDOT MICRO CATHETER AND THE PATIENT EXPERIENCED PERICARDIAL EFFUSION (PE) TREATED WITH PERICARDIOCENTESIS WHICH REQUIRED EXTENDED HOSPITALIZATION. THE REPORT INDICATED THAT THERE WAS A PERICARDIAL EFFUSION REPORTED DURING AN AFIB PROCEDURE WITH QDOT CATHETER. POST PROCEDURE, THERE WAS A DROP IN THE PATIENTS¿ BLOOD PRESSURE, THE PHYSICIAN CONFIRMED VIA INTRACARDIAC ECHOCARDIOGRAPHY (ICE) THAT THERE WAS A PERICARDIAL EFFUSION PRESENT. PERICARDIOCENTESIS WAS PERFORMED AND ABOUT 200CCS OF FLUID WAS REMOVED. THE DRAINAGE TUBE WAS LEFT IN PLACE, AND THE PATIENT WAS TAKEN TO INTENSIVE CARE UNIT (ICU) FOR OVERNIGHT OBSERVATION, AS PER NORMAL PROCEDURE. THE PATIENT WAS STABLE. THE PHYSICIAN NORMALLY ONLY DOES ONE TRANSSEPTAL PUNCTURE, BUT THEY LOST THE FIRST TRANSSEPTAL ACCESS AND A SECOND TRANSSEPTAL PUNCTURE WAS PERFORMED. THERE WAS A SLIGHT DROP IN BLOOD PRESSURE AFTER THE FIRST TRANSSEPTAL PUNCTURE, BUT THE PHYSICIAN CONFIRMED THERE WAS NO EFFUSION PRESENT AND THE PROCEDURE CONTINUED. THEY THINK THE EFFUSION OCCURRED DURING THE SECOND TRANSSEPTAL PUNCTURE. THE ABLATION CATHETER IS AV

  Patient problems: Cardiac Tamponade

  MAUDE report 24260118 ↗
• InjuryJan 8, 2026Patient Device Interaction Problem

  DURING AN ATRIAL FIBRILLATION AND ATRIAL TACHYCARDIA ABLATION PROCEDURE WITH A QDOT MICRO CATHETER AND THE PATIENT EXPERIENCED HEART BLOCK AND CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS, PACEMAKER IMPLANTATION, CHEST COMPRESSION AND EPINEPHRINE. IT WAS REPORTED THAT DURING THE ATRIAL TACHYCARDIA PORTION OF THE PROCEDURE WITH A QDOT MICRO CATHETER, HEART BLOCK AND A CARDIAC TAMPONADE WERE NOTICED IN THE PATIENT. WHILE ABLATING NEARBY THE CORONARY SINUS (CS) OSTIUM FOR THE ATRIAL TACHYCARDIA, THE PATIENT WENT INTO HEART BLOCK. THE PHYSICIAN REMOVED THE QDOT MICRO CATHETER FROM THE PATIENT, LEAVING JUST THE REPROCESSED INNOVATIVE HEALTH SOUNDSTAR CATHETER IN THE BODY. THEY HAD MAPPED WITH AN OCTARAY CATHETER EARLIER IN THE PROCEDURE, BUT THE OCTARAY CATHETER WAS NO LONGER IN THE BODY AT THIS POINT. THE PHYSICIAN DECIDED TO IMPLANT A PACEMAKER IN THE PATIENT. DURING THE PACEMAKER IMPLANT PROCEDURE, THERE WERE "COMPLICATIONS AND ISSUES" NOTICED WITH THE PATIENT BUT COULD NOT CONFIRM ANY ADDITIONAL DETAILS REGARDING THE COMPLICATIONS OR ISSUES. IT WAS NOTICED THAT THERE WAS A CARDIAC TAMPONADE IN THE PATIENT. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS, AND A QUANTITY

  Patient problems: Cardiac Arrest; Cardiac Tamponade; Heart Block

  MAUDE report 24011847 ↗
• MalfunctionJan 8, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (RIGHT-SIDED) WITH A QDOT MICRO CATHETER AND POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB IDENTIFIED A HOLE IN THE SURFACE OF THE PEBAX. DURING THE PROCEDURE, THE CATHETER WOULD NOT MAINTAIN ZERO. THERE WERE NO ERROR CODES DISPLAYED. THE CATHETER WAS REPLACED AND THE PROCEDURE CONTINUED. THE CASE WAS COMPLETED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24007523 ↗
• InjuryJan 5, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A QDOT MICRO CATHETER AND SUFFERED A CARDIAC PERFORATION WHICH REQUIRED SURGICAL INTERVENTION AND PROLONGED HOSPITALIZATION. THE REPORT INDICATED THAT AFTER ISOLATING THE PULMONARY VEINS AND LEFT ATRIAL POSTERIOR WALL, THERE WAS A PERICARDIAL EFFUSION NOTED. THE PATIENT STARTED HAVING "BLOOD PRESSURE PROBLEMS" (NOTED BY ANESTHESIA), AND INTRACARDIAC ECHOCARDIOGRAPHY (ICE) IMAGING (STRYKER SOUNDSTAR) WAS USED TO DISCOVER THE EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED, BUT THIS DID NOT RESOLVE THE ISSUE. THE PATIENT WAS TAKEN TO SURGERY FOR REPAIR ON POSTERIOR WALL OF LEFT ATRIUM. THE LAST KNOWN PATIENT STATUS WAS STABLE. THE ADDITIONAL INFORMATION RECEIVED INDICATED THAT A 5CM CARDIAC PERFORATION WAS CONFIRMED DURING SURGERY ON THE ROOF BY LEFT SUPERIOR PULMONARY VEIN (LSPV). THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS NOT BIOSENSE WEBSTER, INC. (BWI) PRODUCT MALFUNCTION, BUT PROCEDURE AFIB, AND PATIENT CONDITION (WENT HOME). THE OUTCOME OF THE ADVERSE EVENT WAS THAT THE PATIENT RECOVERED. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF HEART SURGERY AND WAS IN THE HOS

  Patient problems: Cardiac Perforation

  MAUDE report 23970862 ↗
• MalfunctionOct 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A QDOT MICRO CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE ON THE PEBAX. THE PHYSICIAN REPORTED A ¿PRODUCT ISSUE¿. THE CUSTOMER'S REPORTED UNSPECIFIED PRODUCT 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 1-OCT-2025, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND A HOLE IN THE PEBAX WITH INTERNAL COMPONENTS EXPOSED 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 23364975 ↗
• MalfunctionOct 17, 2025Signal Artifact/Noise; Display or Visual Feedback Problem; Signal Artifact/Noise; Display or Visual Feedback Problem

  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 CUT ON THE SURFACE OF THE PEBAX. DURING THE PROCEDURE AT THE START OF ABLATION, THE QDOT IN THE CARTO MAPPING SYSTEM BEGAN TO MOVE RANDOMLY. AFTER REPLACING THE RETURN ELECTRODES AND CHECKING WHETHER A LOCATION PATCH WAS MAKING CONTACT WITH THE RETURN ELECTRODE, THE PROBLEM RECURRED. AFTER REPLACING THE CATHETER CABLE, THE PROBLEM PERSISTED. THE CATHETER WAS REPLACED. THERE WAS A TOTAL 20 MINUTES OF TROUBLESHOOTING THAT HAD OCCURRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING AN STSF CATHETER. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23320891 ↗
• MalfunctionSep 16, 2025Contamination; Entrapment of Device; Contamination /Decontamination Problem; Appropriate Device Problem Term/Code Not Available; Contamination; Entrapment of Device; Contamination /Decontamination Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A QDOT MICRO CATHETER AND A MEDICAL DEVICE ENTRAPMENT WITH EXCESSIVE MANIPULATION REQUIRED ISSUE OCCURRED. AFTER THEY WERE ABLE TO RETRACT THE CATHETER, FOREIGN MATERIAL ON THE USABLE LENGTH OF THE CATHETER WAS OBSERVED. DURING MAPPING AND DEFINITION OF THE RIGHT SUPERIOR PULMONARY VEIN (LEFT ATRIUM), THE OPERATOR WAS UNABLE TO RETRACT THE QDOT MICRO CATHETER. DURING THE ATTEMPTS, THE CATHETER EXHIBITED PROGRESSIVELY INCREASING RESISTANCE UNTIL REACHING HI (HIGH). RETRACTION WAS ONLY POSSIBLE AFTER COMPLETE ADVANCEMENT OF THE LONG INTRODUCER. UPON VISUAL INSPECTION, THE CATHETER TIP APPEARED TO BE COVERED IN A THIN LAYER OF TRANSPARENT/WHITISH, FILM-LIKE MATERIAL, WHICH ALSO PREVENTED PROPER CATHETER FLUSHING. THE DEVICE WAS THEREFORE REPLACED. THE PROCEDURE WAS NOT DELAYED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED. THE FOREIGN MATERIAL WAS NOT INSIDE THE PACKAGING. THE CATHETER WAS FLUSHING WELL PRIOR TO INSERTION. IT WAS OBSERVED ONLY DURING INSPECTION AFTER THE EVENT, WHEN THEY WERE ABLE TO RETRACT THE CATHETER. IT WAS UNKNOWN IF THE

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23068900 ↗
• MalfunctionSep 10, 2025Coagulation in Device or Device Ingredient; Device Contamination with Body Fluid; Coagulation in Device or Device Ingredient; Device Contamination with Body Fluid

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A QDOT MICRO AND AFTER THE PROCEDURE, THE DOCTOR NOTICED SOME CHARRING ABOVE THE ELECTRODE. THE PATIENT HAD NO COMPLICATIONS. CHAR WAS LOCATED BETWEEN TIP ELECTRODE AND ELECTRODE 2 AT THE PLASTIC RING SEPARATING THE ELECTRODES. THE SYSTEM DID NOT PRESENT ANY ERROR MESSAGES, THE PHYSICIAN/USER DID NOT SEE ANY PRODUCT PROBLEM, THERE WERE NO ISSUES RELATED TO TEMPERATURE AND FLOW ON THE CATHETER. GENERATOR PARAMETERS WERE QMODE+, POWER 90 WATTS, TEMPERATURE TARGET 55°C, TEMPERATURE CUT OFF 65°C. PATIENT WAS ANTICOAGULATED AND THE ACTIVATED CLOTTING TIME WAS GREATER THAN 300 SECONDS, WHICH WAS MAINTAINED THROUGHOUT THE CASE. THE PATIENT HAS NOT EXHIBITED ANY NEUROLOGICAL SYMPTOMS SINCE THE PROCEDURE WAS COMPLETED. THE PHYSICIAN CONSIDERS THAT THE CHAR/THROMBUS/CLOT WAS EXCESSIVE AND THAT THE AMOUNT OF CHAR/THROMBUS/CLOT TO BE AN INCREASED RISK. CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. PUMP WAS SWITCHING FROM ¿LOW¿ TO ¿HIGH¿ FLOW DURING ABLATION. ABLATIONS WERE DONE IN QMODE+ FOR FOUR SECONDS. THE PHYSICIAN AIMS FOR 5-15 GRAMS OF FORCE. IRRIGATION RATE WAS NOT USED OUTSIDE OF THOSE PRESCRIBED. THE PRE-A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23022470 ↗
• MalfunctionSep 10, 2025Coagulation in Device or Device Ingredient; Device Contamination with Body Fluid; Coagulation in Device or Device Ingredient; Device Contamination with Body Fluid

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A QDOT MICRO¿ CATHETER AND THE DOCTOR NOTICED SOME CHARRING ABOVE THE ELECTRODE, SPECIFICALLY BETWEEN THE TIP ELECTRODE AND ELECTRODE 2 AT THE PLASTIC RING SEPARATING THE ELECTRODES. THERE WERE NO SYSTEM ERRORS OR MESSAGES PRESENT PRIOR TO IDENTIFYING THE CHAR. THERE WERE NO TEMPERATURE OR FLOW ISSUES. THE GENERATOR PARAMETERS WERE AS FOLLOWS: QMODE+ 90W TEMPERATURE TARGET: 55°C TEMPERATURE CUT OFF: 65°C. THE CORRECT GENERATOR SETTINGS WERE SELECTED. THE PUMP WAS ALSO SWITCHING FROM "LOW" TO "HIGH" FLOW PROPERLY DURING THE PROCEDURE. NO EXCESSIVE FORCE WAS USED. THE IRRIGATION RATE WAS APPROPRIATE AS WELL. HEPARINIZED NORMAL SALINE WAS THE IRRIGATION FLUID USED IN THE PROCEDURE. THE PATIENT WAS ANTICOAGULATED WITH AN ACTIVATED CLOTTING TIME OF GREATER THAN 300, A VALUE THAT WAS MAINTAINED THROUGHOUT THE CASE. THE PHYSICIAN DETERMINED THAT THE AMOUNT OF CHAR WAS EXCESSIVE AND PRESENTED AN INCREASED PATIENT RISK. NO FURTHER DETAILS WERE PROVIDED REGARDING TROUBLESHOOTING OF THE ISSUE OR COMPLETION OF THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23018933 ↗
• MalfunctionSep 9, 2025Coagulation in Device or Device Ingredient; Device Contamination with Body Fluid; Coagulation in Device or Device Ingredient; Device Contamination with Body Fluid

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A QDOT MICRO¿ CATHETER AND THE DOCTOR NOTICED SOME CHARRING ABOVE THE ELECTRODE. THE CHAR WAS IDENTIFIED BETWEEN TIP ELECTRODE 1 AND ELECTRODE 2 AT THE PLASTIC RING SEPARATING THE ELECTRODES. THERE WERE NO ERROR MESSAGES NOTED ON THE SYSTEM PRIOR TO THE DISCOVERY OF THE CHAR. THERE WERE NO ISSUES WITH TEMPERATURE AND FLOW. THE GENERATOR PARAMETERS WERE AS FOLLOWS: QMODE+ 90W TEMPERAURE TARGET: 55°C TEMPERATURE CUT OFF: 65°C 5. THE PATIENT WAS ANTICOAGULATED WITH AN ACT (ACTIVATED CLOTTING TIME) OF APPROXIMATELY 300, A VALUE WHICH WAS MAINTAINED THROUGHOUT THE CASE. THE PHYSICIAN CONSIDERED THE AMOUNT OF CHAR TO BE EXCESSIVE. NO EXCESSIVE FORCE WAS USED. HEPARINIZED NORMAL SALINE WAS USED FOR IRRIGATION. NO FURTHER DETAILS WERE PROVIDED REGARDING TROUBLESHOOTING OF THE ISSUE OR COMPLETION OF THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23008945 ↗
• MalfunctionSep 8, 2025High Readings; High Readings

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A QDOT MICRO. IT WAS INDICATED THAT THE IMPEDANCE ROSE AS SOON AS THEY START TO ABLATE. THEY FLUSHED THE CATHETER SEVERAL TIMES TO CHECK IF THE FLUSH ITSELF WAS FINE. THAT WAS THE CASE. AFTER THIS, THEY TRIED TO ABLATE ONCE AGAIN; HOWEVER, THE IMPEDANCE WAS STILL THE PROBLEM. THEY EXCHANGED THE CATHETER. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. THIS WAS ORIGINALLY ASSESSED AS NOT MDR REPORTABLE. THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J) FOR EVALUATION. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION, TEMPERATURE AND IMPEDANCE TEST OF THE RETURNED DEVICE WERE PERFORMED. VISUAL ANALYSIS REVEALED A CUT ON THE SURFACE WITH REDDISH MATERIAL INSIDE THE PEBAX. THIS FINDING IS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22995029 ↗
• MalfunctionSep 5, 2025Coagulation in Device or Device Ingredient; Device Contamination with Body Fluid; Coagulation in Device or Device Ingredient; Device Contamination with Body Fluid

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A QDOT MICRO WHICH HAD EXCESSIVE CHARRING. DURING ABLATION, THE DOCTOR NOTICED THAT CHARRING WAS VISIBLE ABOVE THE ELECTRODE; BETWEEN TIP ELECTRODE AND ELECTRODE 2 AT THE PLASTIC RING SEPARATING THE ELECTRODES. THERE WAS NO CONSEQUENCES FOR THE PATIENT. PER THE PHYSICIAN, THE CHARRING WAS CONSIDERED TO BE EXCESSIVE AND THE DOCTOR ESTIMATES THE PATIENT RISK TO BE INCREASED. THE SYSTEM DID NOT PRESENT ANY ERROR MESSAGES AND THE PHYSICIAN DID NOT SEE ANY PRODUCT PROBLEMS DURING USE. THERE WERE NO ISSUES RELATED TO TEMPERATURE OR FLOW ON THE CATHETER. HEPARINIZED NORMAL SALINE WAS USED AND THE PATIENT WAS ANTICOAGULATED WITH ACTIVATED CLOTTING TIME (ACT) OF >300 MAINTAINED THROUGHOUT. THE PATIENT HAS NOT EXHIBITED ANY NEUROLOGICAL SYMPTOMS SINCE THE PROCEDURE WAS COMPLETED. THE CORRECT CATHETER SETTINGS WERE SET ON THE NGEN GENERATOR AND THE NGEN PUMP WAS SWITCHING FROM ¿LOW¿ TO ¿HIGH¿ FLOW DURING ABLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22976976 ↗
• InjurySep 5, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER RIGHT (R-AFL) ABLATION WITH A QDOT MICRO CATHETER AND THE PATIENT EXPERIENCED FIRST DEGREE HEART BLOCK WITH DROPPED BEATS TREATED WITH PACEMAKER IMPLANT. IT WAS REPORTED THAT AFTER THE CAVOTRICUSPID ISTHMUS (CTI) ABLATION FOR ATRIAL FLUTTER, THE PATIENT EXPERIENCED FIRST DEGREE HEART BLOCK WITH SOME DROPPED BEATS. THE PATIENT ARRIVED TO THE LAB IN INCESSANT 200MS ATRIAL FLUTTER THAT TERMINATED DURING RADIOFREQUENCY (RF) ABLATION. THE HEART BLOCK WAS NOTICED ON CARTO 3 SYSTEM AND EP RECORDING SYSTEM EKG'S. THE PHYSICIAN DECIDED TO IMPLANT A MICRA PACEMAKER INTO THE VENTRICLE. THE PATIENT WAS STABLE AND STILL EXPECTED TO BE DISCHARGED THE SAME DAY. THE PATIENT HAD COMORBIDITIES, INCLUDING A RECENT HEART TUMOR. THE PHYSICIAN DID NOT BELIEVE THAT BIOSENSE WEBSTER INC (BWI) PRODUCTS HAD ANYTHING TO DO WITH THE PATIENT'S HEART BLOCK. THEY DID NOT KNOW WHAT THE UNDERLYING RHYTHM WAS BECAUSE OF THE INCESSANT FLUTTER.

  Patient problems: Heart Block

  MAUDE report 22975773 ↗
• MalfunctionSep 2, 2025Erratic or Intermittent Display; Incorrect, Inadequate or Imprecise Result or Readings; Erratic or Intermittent Display; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE WITH A QDOT MICRO CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE IN THE SURFACE OF THE PEBAX. DURING THE START OF THE ABLATION, THERE WAS A VERY STRANGE BEHAVIOR OF THE CATHETER. WHEN STARTING, THE ABLATION CATHETER JUMPED TO ANOTHER LOCATION BUT THE CATHETER WAS IN THE SAME STABLE LOCATION. INTERFERENCE OF SOMETHING? ALSO, FORCE WENT FROM 10 GRAMS TO 80 GRAMS WHEN STARTING. THE NEUTRAL PLATE STUCK ON ANOTHER LOCATION BUT THE SAME BEHAVIOR WAS DURING START OF THE ABLATION. THE CABLE WAS REPLACED BY A NEW ONE, BUT STILL THE SAME ISSUES. DURING THESE ISSUES, NO SPECIFIC ERROR. AFTER REPLACING THE CATHETER WITH A NEW ONE, THE PROBLEM WAS SOLVED. THE PROCEDURE WAS DELAYED 15 MINUTES. ACTION TAKEN WAS A NEW NEUTRAL PLATE, CABLE, NEW POSITION, NEW CATHETER CABLE, AND NEW CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES OR PATIENT ISSUES. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON (B)(6) 2025 THERE WAS REDDISH MATERIAL INSIDE THE PEBAX. A DETAILED INSPECTION WAS PERFOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22939313 ↗
• MalfunctionAug 13, 2025Coagulation in Device or Device Ingredient; Device Contamination with Body Fluid; Coagulation in Device or Device Ingredient; Device Contamination with Body Fluid

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A QDOT MICRO¿ CATHETER AND THE DOCTOR NOTICED SOME CHARRING ABOVE THE ELECTRODE. THE CHAR WAS LOCATED ABOVE THE ELECTRODE BETWEEN THE TIP ELECTRODE AND ELECTRODE 2 AT THE PLASTIC RING SEPARATING THE ELECTRODES. THE SYSTEM DID NOT PRESENT ANY ERROR MESSAGES OR PRODUCT PROBLEM. THERE WERE NO ISSUES NOTED WITH THE TEMPERATURE OR FLOW OF THE CATHETER. THE CORRECT CATHETER SETTINGS WERE SELECTED. THE GENERATOR PARAMETERS WERE AS FOLLOWS: QMODE+ ¿ 90W ¿ TEMPERATURE TARGET: 55°C ¿ TEMPERATURE CUT OFF: 65°C. THE ACT (ACTIVATED CLOTTING TIME) WAS ABOVE 300 AND MAINTAINED THROUGHOUT THE CASE. HEPARINIZED NORMAL SALINE WAS USED FOR IRRIGATION. THE PHYSICIAN DETERMINED THAT THE CHARRING COULD PRESENT AN INCREASED RISK TO THE PATIENT. HOWEVER, NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22797185 ↗
• MalfunctionAug 12, 2025Coagulation in Device or Device Ingredient; Device Contamination with Body Fluid; Coagulation in Device or Device Ingredient; Device Contamination with Body Fluid

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A QDOT MICRO WHICH HAD EXCESSIVE CHARRING. DURING ABLATION, THE DOCTOR NOTICED THAT CHARRING WAS VISIBLE ABOVE THE ELECTRODE; BETWEEN TIP ELECTRODE AND ELECTRODE 2 AT THE PLASTIC RING SEPARATING THE ELECTRODES. THERE WAS NO CONSEQUENCES FOR THE PATIENT.PER THE PHYSICIAN, THE CHARRING WAS CONSIDERED TO BE EXCESSIVE AND THE DOCTOR ESTIMATES THE PATIENT RISK TO BE INCREASED. THE SYSTEM DID NOT PRESENT ANY ERROR MESSAGES AND THE PHYSICIAN DID NOT SEE ANY PRODUCT PROBLEMS DURING USE. THERE WERE NO ISSUES RELATED TO TEMPERATURE OR FLOW ON THE CATHETER. HEPARINIZED NORMAL SALINE WAS USED AND THE PATIENT WAS ANTICOAGULATED WITH ACTIVATED CLOTTING TIME (ACT) OF >300 MAINTAINED THROUGHOUT. THE PATIENT HAS NOT EXHIBITED ANY NEUROLOGICAL SYMPTOMS SINCE THE PROCEDURE WAS COMPLETED. THE CORRECT CATHETER SETTINGS WERE SET ON THE NGEN GENERATOR AND THE NGEN PUMP WAS SWITCHING FROM ¿LOW¿ TO ¿HIGH¿ FLOW DURING ABLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22790590 ↗
• MalfunctionAug 12, 2025Signal Artifact/Noise; Incorrect, Inadequate or Imprecise Result or Readings; Signal Artifact/Noise; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE AND POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB IDENTIFIED A HOLE IN THE PEBAX. DURING THE PROCEDURE, THERE WAS NOISE ON ON THE PROXIMAL OF THE DISTAL ELECTRODE PAIR OF THE CATHETER DISPLAYED ON THE CARTO 3 SYSTEM AND THE RECORDING SYSTEM WHILE ON RF (RADIOFREQUENCY). THE CABLE WAS REPLACED WITHOUT RESOLUTION. THE CATHETER WAS REPLACED AS WELL. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT CATHETER. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22784682 ↗
• MalfunctionAug 5, 2025Coagulation in Device or Device Ingredient; Device Contamination with Body Fluid; Coagulation in Device or Device Ingredient; Device Contamination with Body Fluid

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A QDOT MICRO WHICH HAD EXCESSIVE CHARRING. AFTER A SUCCESSFULLY COMPLETED PULMONARY VEIN ISOLATION (PVI) PROCEDURE WITHOUT ANY PATIENT CONSEQUENCES, THE PHYSICIAN PULLED OUT THE QDOT AND NOTICED CHARRING ON THE CATHETER TIP. THERE WAS NO PATIENT CONSEQUENCE. CHAR IS A PHYSICAL PHENOMENON OF RADIOFREQUENCY ABLATION AND CAN BE A NORMAL RESULT OF THE ABLATION PROCESS. THE PRESENCE OF CHAR DOES NOT BY ITSELF REPRESENT A SERIOUS INJURY, NOR IS IT NECESSARILY THE RESULT OF A DEVICE MALFUNCTION. AS SUCH, CHAR IS NOT MDR REPORTABLE. ON 9-JUL-2025, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THERE WERE NO ERROR MESSAGES. NO ISSUES RELATED TO TEMPERATURE OR FLOW. THE PATIENT WAS ANTICOAGULATED ABOVE 300, IT WAS MAINTAINED DURING THE CASE. HEPARINIZED NORMAL SALINE WAS USED. CORRECT CATHETER SETTINGS WERE SELECTED ON THE NGEN GENERATOR. THE PATIENT HAS NOT EXHIBITED ANY NEUROLOGICAL SYMPTOMS SINCE THE PROCEDURE WAS COMPLETED. THE PHYSICIAN REPORTED THE CHARRING WAS CONSIDERED NOT TO BE EXCESSIVE, HOWEVER, THE DOCTOR CONSIDERS THE RISK TO THE PATIENT TO BE POTENTIALLY INCREASED. BASED ON THIS NEW PHYSICIAN¿S OPINION,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22723134 ↗
• MalfunctionAug 5, 2025Coagulation in Device or Device Ingredient; Insufficient Cooling; Device Contamination with Body Fluid; Coagulation in Device or Device Ingredient; Insufficient Cooling; Device Contamination with Body Fluid

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A QDOT MICRO CATHETER AND THE PHYSICIAN CONSIDERED THE AMOUNT OF CHAR OBSERVED CAUSED A POTENTIAL RISK TO THIS PATIENT. AFTER A SUCCESSFULLY COMPLETED PULMONARY VEIN ISOLATION (PVI) PROCEDURE WITHOUT ANY PATIENT CONSEQUENCES, THE PHYSICIAN PULLED OUT THE QDOT MICRO CATHETER AND NOTICED CHARRING ON THE CATHETER TIP. NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED ON 09-JUL-2025. NO ERROR MESSAGE, BUT ABLATION BEHAVIOR REGARDING TEMPERATURE WAS IRREGULAR DURING ABLATION. THE PHYSICIAN PULLED OUT THE CATHETER AND NOTICED CHARRING. THEN USED A NEW ONE. TEMPERATURE ISSUE, SLOPE VERY FAST TOO HIGH. GENERATOR USED QMODE PLUS AND QMODE QMODE+, 90W, TEMPERATURE TARGET: 55°C AND TEMPERATURE CUT OFF: 65°C. THE PATIENT WAS ANTICOAGULATED ABOVE 300. IT WAS MAINTAINED DURING THE CASE. THE PHYSICIAN DOES NOT CONSIDER THAT THE CHAR WAS EXCESSIVE. THE PHYSICIAN CONSIDERED THE AMOUNT OF CHAR OBSERVED CAUSED A POTENTIAL RISK TO THIS PATIENT, BUT NO HARM TO THE PATIENT HAPPENED OR WAS NOTICED. CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THERE WERE NO ISSUES WITH THE FLOW RATE CHANGE AT THE START OF THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22720339 ↗
• MalfunctionAug 3, 2025Coagulation in Device or Device Ingredient; Device Contamination with Body Fluid; Coagulation in Device or Device Ingredient; Device Contamination with Body Fluid

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A QDOT MICRO. INITIALLY, IT WAS INDICATED THAT AFTER A SUCCESSFULLY COMPLETED PULMONARY VEIN ISOLATION (PVI) PROCEDURE WITHOUT ANY PATIENT CONSEQUENCES, THE PHYSICIAN PULLED OUT THE QDOT AND NOTICED CHARRING ON THE CATHETER TIP. WITH THE INITIAL INFORMATION AVAILABLE, THIS EVENT WAS ASSESSED AS NON MDR REPORTABLE. HOWEVER, ON 09-JUL-2025, ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THE PHYSICIAN DID NOT CONSIDER THE AMOUNT OR CHAR AS EXCESSIVE; HOWEVER, HE CONSIDERED THE AMOUNT OF CHAR OBSERVED AS A POTENTIAL RISK TO THE PATIENT, BUT NO HARM HAPPENED TO THE PATIENT OR WAS NOTICED. THEREFORE, THE EVENT WAS RE-ASSESSED AS MDR REPORTABLE WITH AN AWARENESS DATE OF 09-JUL-2025. THE SYSTEM DID NOT PRESENT ANY ERROR MESSAGES. THE PHYSICIAN PULLED OUT THE CATHETER AND NOTICED CHARRING. THEN, A NEW ONE WAS USED. THE PATIENT WAS ANTICOAGULATED ABOVE 300, AND IT WAS MAINTAINED DURING THE CASE. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR AND THERE WERE NO ISSUES WITH FLOW RATE CHANGE AT THE START OF THE ABLATION. HEPARINIZED NORMAL SALINE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22695759 ↗