QDOT MICRO D139504Recalls & reported problems

Summary

The FDA's MAUDE database contains 138 adverse event reports that list this exact device (DI 10846835016741), received between Aug 23, 2023 and Sep 23, 2026 — classified as 7 deaths, 50 injuries, 81 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (50 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 138 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Patient Device Interaction Problem

  It was reported that a patient underwent an atrial fibrillation ablation with a QDOT Micro Catheter and the patient experienced cardiac arrest/asystole that required CPR (cardiopulmonary resuscitation).After ablating, (pulmonary vein isolation--posterior wall with the Farawave and cavotricuspid isthmus with the QDOT), the patient's heart stopped with a rapid drop in blood pressure. CPR was started and a TEE (transesophageal echocardiogram) was performed--no effusion was noted. The patient's vital signs eventually returned to baseline after about 10 minutes. The patient fully recovered but required extended hospitalization (the doctor wanted to keep the patient overnight to monitor him).The event occurred after catheters and sheaths were removed at the end of the procedure. The physician believes it was an allergic reaction to protamine.

  Patient problems: Asystole; Cardiac Arrest

  MAUDE report 50872908 ↗
• DeathSep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent an Atrial Fibrillation ablation procedure with a QDOT MICRO Catheter and a Watchman Appendage closure wherein the patient experienced cardiac arrest that required Cardiopulmonary Resuscitation (CPR), pacing and ECMO, ventricular fibrillation that required cardioversion, and hemorrhage. The patient expired.At the conclusion of Atrial fibrillation ablation, during the process of extubating, patient developed bradycardia followed by hypotension. Soon after, loss of pulse was noted by anesthesiologist and CPR was started. X-ray showed that the right ventricle was not moving. No effusion was noted via trans-esophageal echocardiogram (TEE). Pulse was noted after initial CPR for a short period. Transvenous pacemaker catheter was inserted. Patient developed ventricular fibrillation soon after and shocked to restore sinus rhythm was performed. Extracorporeal membrane oxygenation was inserted with normalization of blood pressure. However, abdominal distention was noted by echocardiogram that there was blood around the patient¿s liver. Decision was made to have a CT, results are unknown. Patient was placed in the intensive care unit where he passed awa

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding; Ventricular Fibrillation

  MAUDE report 50781131 ↗
• InjuryJul 31, 2026Patient Device Interaction Problem

  It was reported that a patient underwent a device implant with AV (atrioventricular) node ablation with a QDOT MICRO catheter and the patient experienced cardiac tamponade that required pericardiocentesis.After being transferred to the inpatient unit post-procedure, the patient was noted to have hypotension. A bedside echo noted a pericardial effusion. A pericardiocentesis was performed with approximately 250mL of fluid removed.The physician doesn't think the issue is due to the ablation portion of the procedure. There were no high force readings or any other issues noted during ablation (3 minutes total ablation time). It was also reported that the patient had a Bi-V pacemaker implanted prior to ablation. During positioning of the CS (coronary sinus) lead during the device implant, contrast was not used due to patient allergy.

  Patient problems: Cardiac Tamponade

  MAUDE report 50106839 ↗
• DeathJun 3, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT RECEIVED AN INDEX CARDIAC ABLATION PROCEDURE WITH A QDOT MICRO ON (B)(6) 2026. ON (B)(6) 2026, PATIENT EXPERIENCED SUDDEN DEATH (ADVERSE EVENT #1) CATEGORIZED AS SEVERE AND SERIOUS DEFINED BY DEATH. RELATIONSHIP TO STUDY DEVICE IS NOT RELATED AND RELATIONSHIP TO THE INDEX STUDY PROCEDURE IS NOT RELATED. THE OUTCOME IS DEATH. INTERVENTION WAS NONE. THE CLINICAL DATABASE REPORTS THAT THE TYPE OF MORTALITY IS UNKNOWN AS THE ONLY INFORMATION IS THAT THE PATIENT SUDDENLY DIED.

  Patient problems: Insufficient Information

  MAUDE report 25382278 ↗
• MalfunctionMar 18, 2026Manufacturing, Packaging or Shipping Problem; Output below Specifications

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A QDOT MICRO CATHETER AND POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB IDENTIFIED DAMAGE WITH FOREIGN MATERIAL ON THE SECOND ELECTRODE OF THE TIP. MID-PROCEDURE THE CATHETER BEGAN TO "TITRATE" POWER, PROGRESSIVELY TRENDING DOWN UNTIL IT REACHED 1 WATT OF POWER, ON THE NGEN¿ GENERATOR. THERE WERE NO SPECIFIC ERROR MESSAGES DISPLAYED AT THE TIME. THE PHYSICIAN HAD CONFIRMED THE QDOT WAS IRRIGATING PROPERLY. THE CATHETER WAS REMOVED FROM THE BODY AND THERE WAS NOTHING OBSTRUCTING THE IRRIGATION EITHER. THE PROCEDURE CONTINUED AND COMPLETED WITH THE ISSUE UNRESOLVED AND PERSISTING. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24632457 ↗
• InjuryFeb 27, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT-SIDED ATRIAL FLUTTER PROCEDURE WITH QDOT MICRO AND THE PATIENT EXPERIENCED ST ELEVATION (ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION), AV BLOCK, NO BLOOD PRESSURE TREATED WITH CHEST COMPRESSION. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION. THE REPORT INDICATED THAT DURING A RIGHT-SIDED ATRIAL FLUTTER PROCEDURE WITH QDOT CATHETER, ABOUT 12 MINUTES AFTER COMPLETING ABLATION, ST ELEVATION AND AV BLOCK WERE OBSERVED IN THE PATIENT, ON THE RECORDING SYSTEM. SHORTLY AFTER THAT, THE ANESTHESIOLOGIST CONFIRMED THAT THE PATIENT HAD NO BLOOD PRESSURE AND CHEST COMPRESSION WAS ADMINISTERED. A STEMI (ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION) WAS CALLED FOR THE PATIENT. THE PATIENT¿S LAST KNOWN STATUS WAS STABLE. THE QDOT MICRO CATHETER IS NOT AVAILABLE FOR RETURN AND COULD NOT CONFIRM THE LOT NUMBER FOR THE CATHETER. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS ANESTHESIA CARE. THE PATIENT¿S CONDITION HAS WORSENED AND HAD DIFFICULTY AWAKENING FROM SEDATION. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF BEING HELD AT THE HOSPITAL FOR OBSERVATION AND EVALUATION.

  Patient problems: Cardiac Arrest; Heart Block; Ischemic Heart Disease; Myocardial Infarction

  MAUDE report 24475040 ↗
• MalfunctionFeb 26, 2026Device Sensing 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 SECTION WITH A REDDISH MATERIAL INSIDE IT. INITIALLY THE PHYSICIAN REPORTED A TEMPERATURE SENSOR CATHETER ERROR. TO COMPLETE THE PROCEDURE, THE PHYSICIAN USED ANOTHER ONE OF THE SAME TYPE. NO CONSEQUENCES FOR THE PATIENT REPORTED. THE CUSTOMER'S REPORTED TEMPERATURE SENSOR ERROR 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 5-FEB-2026, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND A SEPARATION BETWEEN THE PEBAX AND ELECTRODE SECTION WITH A REDDISH MATERIAL INSIDE IT. THESE FINDINGS WERE REVIEWED AND ASSESSED THE ISSUE OF A ¿SEPARATION¿ 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 24464777 ↗
• InjuryFeb 5, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WTIH A QDOT MICRO AND THE PATIENT EXPERIENCED PERICARDIAL EFFUSION THAT REQUIRED PERICARDIOCENTESIS. FIRST IT WAS REPORTED THAT THE CARTO 3 SYSTEM DISPLAYED ERROR 6150 (SOUNDSTAR® CATHETER SENSOR ERROR) WHEN THE CATHETER WAS ADVANCED INTO THE BODY. THE CATHETER WAS RESEATED WITHOUT RESOLUTION. THE ULTRASOUND MACHINE WAS REBOOTED BUT THE ISSUE PERSISTED. THE CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED. THE CUSTOMER'S REPORTED ERROR 6150 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. THEN A PERICARDIAL EFFUSION WAS REPORTED. THE PATIENT'S BLOOD PRESSURE STARTED TO DROP. PERICARDIAL EFFUSION WAS OBSERVED ON INTRACARDIAC ECHO (ICE) DURING ABLATION IN THE VENTRICLE. THE PROCEDURE CONTINUED AND WAS COMPLETED BUT THE PATIENT REQUIRED A PERICARDIOCENTESIS (450 CCS OF BLOOD WAS REMOVED). THE PATIENT IMPROVED AND DID NOT REQUIRE EXTENDED HOSPITAL STAY (WAS ONLY REPORTED TO HAVE STAYED THE NIGHT AT THE HOSPITAL). THE PHYSICIAN'S OPINION O

  Patient problems: Cardiac Tamponade

  MAUDE report 24275222 ↗
• InjuryJan 22, 2026Patient Device Interaction Problem

  A MONTH AFTER A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A QDOT MICRO CATHETER, THE PATIENT EXPERIENCED PERICARDITIS, AND IS UNDER CARDIOLOGY SERVICE. THE REPORT INDICATED THAT THE PATIENT CAME BACK WITH PERICARDITIS ONE MONTH AFTER AF ABLATION AND IS IN INTENSIVE CARDIOLOGY SERVICE. THE PATIENT DID NOT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT IT IS A RARE BUT OCCURRING EVENT DUE TO ABLATION. THE PATIENT¿S OUTCOME FROM THE ADVERSE EVENT WAS REPORTED AS IMPROVED. THE PATIENT DID NOT REQUIRE CARDIAC SURGERY. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE THE PATIENT CAME BACK TO HOSPITAL AND NEEDED EXTRA HOSPITALIZATION. THE NUMBER OF PERFORMED ABLATIONS WAS 140 WITH RADIOFREQUENCY (RF) ENERGY WITH QDOT MICRO. THE TRANSSEPTAL PUNCTURE WAS PERFORMED WITH BOSTON NEEDLES, BAYLIS. THE FLOW SETTINGS WERE QMODE AND QMODE+ AND THERE WERE NO ISSUES WITH FLOW RATE CHANGE AT THE START OF THE ABLATION. THE FORCE VISUALIZATION FEATURES

  Patient problems: Pericarditis

  MAUDE report 24144083 ↗
• MalfunctionJan 15, 2026Failure to Sense

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE WITH QDOT MICRO CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE IN THE SURFACE OF THE PEBAX. INITIALLY REPORTED A DEFECTIVE DEVICE. NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. ERROR 106: FORCE SENSOR ERROR. CHANGING THE CABLE DID NOT SOLVE THE ISSUE. A SECOND CATHETER WAS USED, SAME ISSUE. USE OF THIRD CATHETER TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCE REPORTED. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 20-DEC-2025, OBSERVED A HOLE IN THE SURFACE OF THE PEBAX AND REDDISH MATERIAL INSIDE. THE EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF A HOLE IN THE SURFACE OF THE PEBAX ON 20-DEC-2025 AND HAVE ASSESSED THIS RETURNED CONDITION AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24090564 ↗
• MalfunctionDec 28, 2025Signal Artifact/Noise; Device Contamination with Body Fluid; Device Sensing Problem; Signal Artifact/Noise; Device Contamination with Body Fluid; Device Sensing Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ISCHEMIC VENTRICULAR TACHYCARDIA (ISVT) PROCEDURE WITH A QDOT MICRO CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A SEPARATION BETWEEN THE PEBAX AND THE ELECTRODE. INITIALLY REPORTED THAT THERE WAS NOISE ON THE ABLATION CATHETER SIGNALS ON BOTH THE CARTO 3 SYSTEM AND THE RECORDING SYSTEM. THE PHYSICIAN REMOVED THE CATHETER TO INSPECT FOR CHAR AND THERE WAS A VERY SMALL AMOUNT OF CHAR ON THE CATHETER. THE CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS CONTINUED. THERE WAS NO IMPEDANCE SPIKES DURING THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE CATHETER WAS BRAND NEW FROM BIOSENSE WEBSTER, INC. BOX PACKAGING. ` ADDITIONAL INFORMATION WAS RECEIVED. THE CHAR WAS ON THE TIP ELECTRODE. NO ERRORS WERE PRESENT, NO ISSUES NOTED OTHER THAN NOISE. PATIENT WAS ANTICOAGULATED, ACT PRACTICE 350 OR ABOVE, MAINTAINED THROUGH CASE. CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. NO ISSUES WITH FLOW RATE CHANGE AT THE START OF THE ABLATION. THE DURATION OF ABLATION USED WAS LESS THAN 60 SECONDS. THE SPECIFIC TIME WAS UNKNOWN FOR THE AVERAGE CONTACT FORCE, BUT NEVER RECEIVED RED FL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23903984 ↗
• InjuryDec 26, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE WITH A QDOT MICRO AND SUFFERED A CARDIAC TAMPONADE WHICH REQUIRED A PERICARDIOCENTESIS AND SURGICAL INTERVENTION. INITIALLY, THE REPORT INDICATED THAT THE IRRIGATION TUBING HAD MICROBUBBLES THAT COULD NOT BE FLUSHED OUT. THEY REPLACED THE TUBING SET TO RESOLVE AND CONTINUE. THEN, LATER IN THE CASE, THE PATIENT SUFFERED CARDIAC PERFORATION AND PERICARDIAL EFFUSION. PRIOR TO THE FIRST ABLATION, THE PHYSICIAN MENTIONED THEY "FELT SOMETHING" (THE CALLER BELIEVED IT REFERRING TO A PERFORATION). THEN, THEY PROCEEDED TO PERFORM A ONE (1) MINUTE RADIO FREQUENCY (RF) ABLATION. THEY NOTICED THE PATIENT'S BLOOD PRESSURE HAD LOWERED AND THE EFFUSION WAS CONFIRMED ON INTRACARDIAC ECHO (ICE). PERICARDIOCENTESIS WAS PERFORMED AND THE REMOVED BLOOD WAS REPLACED WITH "CELL SAVER." THE PATIENT WAS REPORTED STABLE BUT WAS THEN TRANSFERRED TO THE OPERATING ROOM (OR) FOR FURTHER SURGICAL INTERVENTION. THE CURRENT PATIENT STATUS WAS UNKNOWN. THE INFORMATION RECEIVED INDICATED THAT THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS PERFORATION AT LEFT ATRIAL APPENDAGE (LAA). THE OTHER RELEVANT HISTORY/PREEXIST

  Patient problems: Cardiac Perforation

  MAUDE report 23898712 ↗
• InjuryDec 8, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  AFTER AN ACCESSORY PATHWAY ABLATION PROCEDURE WITH A QDOT CATHETER AND THE PATIENT EXPERIENCED PERICARDIAL EFFUSION TREATED WITH PERICARDIOCENTESIS. IT WAS REPORTED THAT AT THE CONCLUSION OF AN ACCESSORY PATHWAY PROCEDURE, A PERICARDIAL EFFUSION WAS NOTICED IN THE PATIENT. WHILE CHECKING FOR AN EFFUSION IN THE PATIENT POST-PROCEDURE, A PERICARDIAL EFFUSION WAS NOTICED AND CONFIRMED ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE MEDICAL INTERVENTION PROVIDED TO THE PATIENT WAS PERICARDIOCENTESIS, AND ABOUT 800ML OF FLUID WAS REMOVED FROM THE PATIENT. THEY ALSO UTILIZED 2D ECHO IN ORDER TO CONFIRM THE PERICARDIAL EFFUSION, AS WELL AS FOR THE PERICARDIOCENTESIS. THE PATIENT IS IN STABLE CONDITION AT THIS TIME. THE PHYSICIAN BELIEVES THE WEBSTER QUADRAPOLAR CATHETER BEING UTILIZED IN THE RIGHT VENTRICLE (RV), COULD HAVE CAUSED THE ISSUE. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS RIGHT VENTRICLE PERFORATION FROM THE RV CATHETER WITH PACING AND ON ISUPREL. THE ENERGY SOURCE USED WHEN THE ADVERSE EVENT OCCURRED WAS RADIOFREQUENCY (RF). THE SHEATH AND THE CATHETERS ONLY WENT TO THE LEFT ATRIUM (LA) WITH ABLATION CATHETER; THERE WAS NO EXCHANGE. ONE TRANSSEPTAL PUNCTURE SI

  Patient problems: Cardiac Tamponade

  MAUDE report 23749103 ↗
• MalfunctionNov 24, 2025Failure to Sense; Material Protrusion/Extrusion; Failure to Sense; Material Protrusion/Extrusion

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ISCHAEMIC VENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A QDOT MICRO AND DAMAGE WAS FOUND ON THE SHAFT ABOUT 10 CM PROXIMAL FROM THE TIP. AFTER INSTALLING A 3RD DONGLE THEY CONNECTED THE QDOT MICRO, WHILE MAPPING WITH AN OPTRELL. THE CUSTOMER WAS VERY CAUTIOUS AND ALTHOUGH THE DONGLE LOOKED NORMAL (GREEN), EARLY IN THE PROCEDURE THE FOLLOWING ERRORS ON CARTO 3 SYSTEM THAT SWITCHED SEVERAL TIMES : 202, 105, 201, 210, 106, 996. ON THE NGEN THERE WAS NORMAL IMPEDANCE AND TEMPERATURE BUT ALSO THE FOLLOWING ERRORS: 170 (ELECTRODE TEMP FAULT), 273 AND A VERY STRANGE ONE , 276: CURRENTLY PACING ELECTRODE NUMBER 9 MICRON. THE NGEN WAS RESTARTED A FEW TIMES AND RESEATED ALL THE CONNECTIONS, BUT THE ERRORS KEPT ON COMING. THE DOCTOR DIDN'T WANT TO USE A NEW CABLE OR CATHETER AND THUS WE SWITCHED TO A SMARTTOUCH CATHETER. AFTER THE CASE , THE CALLER RECONNECTED THE QDOT MICRO WITH THE DONGLE (CATHETER WAS OUTSIDE THE PATIENT). ALTHOUGH THE DONGLE WAS COLORED GREEN THEY GOT THE FOLLOWING ERRORS ON THE CARTO 3 SYSTEM: 210 : ECO CABLE TEST FAILED , 105 : CATHETER SENSOR ERROR AND ON THE NGEN AGAIN THE ERROR 276: CURRENTLY PACING ELECTRODE 9 MICRON. A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23640887 ↗
• MalfunctionNov 18, 2025Device Contamination with Body Fluid; Device Contamination with Body Fluid

  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 FIBROUS FOREIGN MATERIAL ATTACHED ON THE SURFACE OF THE CATHETER TIP. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT AT THE END OF THE PROCEDURE, WHEN THEY REMOVED THE QDOT MICRO, IT WAS FOUND TO HAVE CHAR ON THE CATHETER. THERE WAS NO PATIENT CONSEQUENCES. THE NGEN GENERATOR WAS IN USE WITH SETTINGS ON QMODE+ ON THE POSTERIOR WALL 90WATTS FOR 4 SECONDS. QMODE FOR THE ANTERIOR LESIONS 50 WATTS. NO FORCE ABOVE 40G, VERY FEW LESIONS AT 25G OF FORCE. IRRIGATION RATE WAS USED CORRECTLY AND HEPRANIZED SALINE WAS USED. TEMPERATURE AND FLOW WERE NORMAL. THERE WERE NO ERROR MESSAGES AND THE PHYSICIAN DID NOT NOTE ANYTHING. PER PHYSICIAN, THE CHAR WAS NOT EXTRAORDINARY, IT WAS NOT A RISK TO PATIENT AND THE PATIENT HAS NOT EXHIBITED ANY NEUROLOGICAL SYMPTOMS. 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 REP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23578451 ↗
• InjuryNov 13, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING A CLINICAL TRIAL, IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A QDOT MICRO CATHETER AND SUFFERED A CARDIAC TAMPONADE WHICH REQUIRED A PERICARDIOCENTESIS. PATIENT RECEIVED AN INDEX PSAF ABLATION ON (B)(6) 2025. ON (B)(6) 2025, START DATE, AND (B)(6) 2025 SITE AWARENESS DATE, PATIENT EXPERIENCED CARDIAC TAMPONADE. ADVERSE EVENT STARTED DURING THE ABLATION PROCEDURE) WITH QDOT MICRO CATHETER CATEGORIZED AS SEVERE AND SERIOUS AS DEFINED BY MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY, OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION. THE RELATIONSHIP TO THE STUDY DEVICES IS NOT RELATED. RELATIONSHIP WITH THE INDEX STUDY PROCEDURE WAS CAUSAL WITH EVENT N/A (DOES NOT MEET ABOVE CRITERIA FOR SERIOUS OR PROCEDURAL RELATED. THE OUTCOME IS RECOVERED/RESOLVED WITH AN END DATE OF (B)(6) 2025. INTERVENTION PERFORMED WAS OTHER- PERICARDIOCENTESIS.

  Patient problems: Cardiac Tamponade

  MAUDE report 23544369 ↗
• MalfunctionOct 22, 2025Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE AND WHENEVER ABLATION WAS STARTED, THE QDOT MICRO¿ CATHETER WOULD JUMP UP ON THE SCREEN OF THE CARTO® 3 SYSTEM AND APPEAR MOVING WHEN IT WAS IN THE SAME LOCATION ACCORDING TO FLUOROSCOPY. THE CABLE WAS REPLACED WITHOUT RESOLUTION. THE QDOT MICRO¿ CATHETER WAS REPLACED, AND THE PROBLEM WAS RESOLVED. THE CASE CONTINUED. 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 MAGNETIC FUNCTIONALITY TEST OF THE RETURNED DEVICE WERE PERFORMED. VISUAL INSPECTION REVEALED A REDDISH MATERIAL AND A CUT ON THE PEBAX SURFACE. THIS FINDING IS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23355103 ↗
• InjuryOct 15, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING ISVT PROCEDURE WITH TWO QDOT CATHETERS (D-F/F-J), THE PATIENT EXPERIENCED VF (VENTRICULAR FIBRILLATION) EPISODE, DECREASED BLOOD PRESSURE, LOW EJECTION FRACTION, LOW CONTRACTION ACTIVITY TREATED WITH PATIENT OWN IMPLANTED DEVICE, CHEST COMPRESSIONS, MEDICATION, SWITCHED TO GENERAL ANESTHESIA, AND IMPELLA DEVICE IMPLANT. THE PATIENT WAS TRANSFERRED TO ICU AND STABLE. INITIALLY, IT WAS REPORTED THAT WHEN PACING WITH THE QDOT MICRO CATHETER D-F CATHETER, ALL THE ECG (ELECTROCARDIOGRAM) SIGNALS WERE LOST ON JUST THE CARTO 3 SYSTEM. THE CARTO 3 SYSTEM DISPLAYED ERROR 1, NO COMMUNICATION WITH THE PIU (PATIENT INTERFACE UNIT) WAS DETECTED. THE PIU WAS REBOOTED, AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED. IT WAS REPORTED THAT TOWARDS THE END OF AN ISCHEMIC VT CASE, AFTER RE-INDUCING PATIENT INTO TACHYCARDIA FOR TESTING, THE MEDICAL TEAM HAD ATTEMPTED TO PACE TERMINATE BUT THE MORPHOLOGY HAD CHANGED AND INTEGRATED INTO VF. THEY THEN ATTEMPTED TO PACE TERMINATE WITH ANTI-TACHYCARDIA PACING (ATP) FROM THE PATIENT'S DEVICE, AND THE PATIENT THEN DEGRADED INTO VF. THEY THEN ADMINISTERED AN "EXTERNAL SHOCK," TO THE PATIENT, AND THE PATIENT CAME OUT OF VF. THE PATIENT'S BLOOD PRESS

  Patient problems: Cardiac Arrest; Ventricular Fibrillation

  MAUDE report 23302824 ↗
• MalfunctionSep 19, 2025Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A QDOT MICRO¿ CATHETER AND POST PROCEDURE A BWI PRODUCT ANALYSIS LAB IDENTIFIED A HOLE IN THE PEBAX. DURING THE PROCEDURE, WHILE ABLATING WITH THE QDOT MICRO¿ CATHETER, THE CARTO¿ 3 SYSTEM DISPLAYED ERROR 105, MAP: CATHETER SENSOR ERROR. THE CABLE WAS REPLACED WITHOUT RESOLUTION. THE QDOT MICRO¿ CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23099282 ↗
• MalfunctionSep 15, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT A 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, THE MEDICAL TEAM LOST THE HEAT MAP ON THE CARTO® 3 SYSTEM, AND NO ERRORS WERE DISPLAYED. THE CABLE WAS REPLACED WITHOUT RESOLUTION. THE TX ECO CABLE WAS REPLACED, BUT THE ISSUE REMAINED. THE QDOT MICRO¿ CATHETER WAS REPLACED, BUT THE ISSUE STILL THERE. THE CASE CONTINUED WITHOUT THE HEAT MAP. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23048806 ↗
• MalfunctionAug 12, 2025Coagulation in Device or Device Ingredient; Obstruction of Flow; Coagulation in Device or Device Ingredient; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ISCHEMIC VENTRICULAR TACHYCARDIA (ISVT) PROCEDURE WITH A QDOT MICRO CATHETER. THE QDOT MICRO CATHETER SEEMED TO BE CLOTTED WHEN IN LOW FLOW. THEY PUT IT UP THE RIGHT FEMORAL ARTERY AND THE LOW FLOW "WOULDN'T FLOW." THEY TRIED TO IRRIGATE THE CATHETER OUT OF THE BODY, BUT IT WOULD NOT IRRIGATE. THEY TRIED TO HAND IRRIGATE THE CATHETER, BUT THE ISSUE PERSISTED. THE CATHETER WAS REPLACED AND THE PROBLEM WAS RESOLVED. THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22790396 ↗
• MalfunctionAug 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A QDOT MICRO¿ CATHETER AND POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB IDENTIFIED A SEPARATION BETWEEN THE PEBAX AND THIRD ELECTRODE. DURING THE PROCEDURE, THE QDOT CATHETER HAD HIGH FORCE READINGS OBSERVED ON THE CARTO 3 SYSTEM DURING THE PROCEDURE. THE FORCE WOULD RISE UP TO 50-60 GRAMS WHEN THE MEDICAL TEAM WOULD COME ON ABLATION. THEY WERE ABLE TO ZERO THE QDOT CATHETER. THE CATHETER CABLE WAS REPLACED WITHOUT RESOLUTION. THE CATHETER WAS REPLACED, THE ISSUE RESOLVED. THE PROCEDURE WAS CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22773427 ↗
• MalfunctionAug 7, 2025Erratic or Intermittent Display; Contamination /Decontamination Problem; Erratic or Intermittent Display; 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 ELECTRODE SECTION IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT THE QDOT CATHETER HAD A VISUALIZATION ISSUE DURING THE PROCEDURE. THE CALLER STATED THE QDOT CATHETER HAD JUMPED/MOVED ABOUT A FOOT ON THE CARTO 3 SYSTEM. THE CALLER STATED THERE WERE NO ERRORS DISPLAYED. THE CALLER STATED THE CATHETER CABLE WAS REPLACED WITHOUT RESOLUTION. THE CALLER STATED THE CATHETER WAS REPLACED, THE ISSUE RESOLVED. THE PROCEDURE WAS CONTINUED. THERE WAS NO PATIENT CONSEQUENCE. THE CUSTOMER'S REPORTED VISUALIZATION 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 14-JUL-2025, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND A REDDISH-BROWN MATERIAL INSIDE THE PEBAX AND A SEPARATION BETWEEN THE PEBAX AND THE ELECTRODE SECTION. . THESE FINDINGS WERE REVIEWED AND ASSESSED THE ISSUE OF A ¿SEPARATION¿ IN THE PEBAX ARE AS AN MDR REPORTABLE MALFUNCT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22745918 ↗
• MalfunctionAug 7, 2025Insufficient Cooling; Insufficient Cooling

  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 HOLE ON THE SURFACE OF THE PEBAX. TEMPERATURE SENSOR ERROR (TEMPERATURE TOO HIGH WHILE ABLATING) ISSUE OCCURRED. THE PROCEDURE WAS NOT DELAYED DUE TO THE REPORTED EVENT. NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED. THE TEMPERATURE CUT OFF VALUE WAS EXCEEDED; HOWEVER, THE SYSTEM DID STOP THE ABLATION. IT WAS QMODE+ AND 55 DEGREES THRESHOLD. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 11-JUL-2025, OBSERVED REDDISH MATERIAL, PRESUMABLY BLOOD INSIDE THE PEBAX SECTION. ADDITIONALLY, A HOLE ON THE SURFACE OF THE PEBAX WAS IDENTIFIED, WITHOUT EXPOSED WIRES. THE EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF A HOLE ON THE SURFACE OF THE PEBAX ON 11-JUL-2025 AND HAVE ASSESSED THIS RETURNED CONDITION AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22745277 ↗
• MalfunctionJul 16, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  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 PEBAX. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT FORCE READING WAS AT ABOUT 7-10G OF FORCE, WHILE THE QDOT MICRO CATHETER WAS FLOATING WITH NO CONTACT, AND WHEN COMING ON ABLATION, THE FORCE READING WOULD SLOWLY INCREASE UP TO ABOUT 40-50G OF FORCE. THE CALLER NOTED THAT THERE WERE STILL NO ERRORS DISPLAYED ON THE CARTO¿ 3 SYSTEM. THE QDOT MICRO CATHETER WAS CONNECTED TO A PREVIOUSLY USED CABLE, AND THE ISSUE PERSISTED. THE CABLE WAS REPLACED, WITHOUT RESOLUTION. THE QDOT MICRO CATHETER WAS THEN REPLACED WITH A THERMOCOOL SMARTTOUCH SF CATHETER, AND THE PROCEDURE CONTINUED WITHOUT ANY OTHER ISSUES. THERE WAS NO PATIENT CONSEQUENCE. THE CUSTOMER'S REPORTED FORCE 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 (B)(6) 2025, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND A HOLE IN THE PEBAX AND A REDDISH MATERIAL INSIDE THE PEBAX. THESE FINDING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22527638 ↗