QDOT MICRO D139505Recalls & reported problems

Summary

The FDA's MAUDE database contains 915 adverse event reports that list this exact device (DI 10846835016758), received between Jul 28, 2021 and Sep 30, 2026 — classified as 27 deaths, 396 injuries, 492 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (402 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 915 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Patient Device Interaction Problem

  It was reported that a patient underwent a premature ventricular contraction ablation procedure with a QDOT MICRO Catheter and the patient experienced a cardiac tamponade which required pericardiocentesis.After the ablation, during hemostasis, ST elevation occurred, and echocardiography revealed pericardial effusion. The patient recovered after drainage of the pericardial fluid. The patient has fully recovered.No error message observed on the Biosense Webster equipment during the procedure. Transseptal puncture was not performed. No ablations performed within the Pulmonary Veins. No evidence of a steam pop. The flow setting was set to Pre:2sec, Post: 0sec. The correct catheter settings were selected on the generator. No issues with flow rate change at the start of the ablation. Physician¿s assessment of health hazard is non-serious (moderate/minor). There were no abnormalities observed during product use. The physician¿s opinion on the cause of this adverse event is that upon post-procedural review of the fluoroscopy images, the physician observed that cardiac motion appeared to worsen around the time of Coronary Sinus (CS) catheter insertion. Therefore, the physician believes that

  Patient problems: Cardiac Tamponade

  MAUDE report 50941987 ↗
• InjurySep 28, 2026Patient Device Interaction Problem

  Patient problems: Heart Block

  MAUDE report 50926586 ↗
• MalfunctionSep 28, 2026Insufficient Cooling; Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923022 ↗
• InjurySep 28, 2026Patient Device Interaction Problem

  Patient problems: Cardiac Tamponade

  MAUDE report 50922550 ↗
• MalfunctionSep 22, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50857486 ↗
• MalfunctionAug 28, 2026Positioning Problem; Patient Device Interaction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50501745 ↗
• InjuryJul 30, 2026Patient Device Interaction Problem

  It was reported that a patient underwent a cardiac ablation and the patient experienced cardiac tamponade that required drainage.Cavotricuspid isthmus (CTI) ablation was performed using the QDOT MICRO Catheter and VIZIGO Short. Brockenbrough (BB) was performed using the Soundstar eco catheter. Pulmonary vein isolation (PVI) was performed using the VARIPULSE Catheter, and post-mapping of the left atrium (LA) was performed using OCTARAY. After completion of these procedures, the physician observed a decrease in blood pressure, confirmed using echocardiography, which revealed pericardial effusion. The patient's blood pressure recovered and stabilized after drainage, and the patient left the room.It was stated that the drained blood was venous blood, so the issue might have been related to ablation near the inferior vena cava (IVC), during CTI ablation, or to coronary sinus (CS) catheter insertion.Visitag coloring setting was Tag index. Visitag additional filter used was FOT. Force visualization features were used were CF, Realtime Graph, Vector, Visitag. Parameters for stability were: range: 3mm, time: 3sec, FOT: 25%5g, tag size: 2mm. Procedural activated clotting time was 350 seconds

  Patient problems: Cardiac Tamponade

  MAUDE report 50091230 ↗
• DeathJun 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (BILATERAL PVI AND POSTERIOR WALL ISOLATION WERE PERFORMED) ABLATION WITH A QDOT MICRO CATHETER AND THE PATIENT EXPERIENCED ESOPHAGEAL FISTULA THAT RESULTED IN DEATH. FIFTEEN DAYS POST PROCEDURE THE PATIENT HAD DEVELOPED A LEFT ATRIUM ESOPHAGEAL FISTULA. AT THE TIME OF THE EMERGENCY CALL, THE PATIENT WAS CONSCIOUS AND MADE THE EMERGENCY REQUEST INDEPENDENTLY. THE CHIEF COMPLAINTS AT THE TIME OF THE CALL WERE CHEST PAIN AND FEVER. BY THE TIME THE AMBULANCE ARRIVED, THE PATIENT HAD DEVELOPED IMPAIRED CONSCIOUSNESS. UPON ARRIVAL AT THE HOSPITAL, THE PATIENT WAS ABLE TO SPEAK; HOWEVER, CONVERSATIONS WERE OFTEN INCOHERENT. RIGHT-SIDED PARALYSIS WAS CONFIRMED. A BRAIN MRI AND WHOLE-BODY CT WERE PERFORMED. THE MRI REVEALED SCATTERED MICRO CEREBRAL INFARCTIONS AND THE CT SHOWED THE PRESENCE OF AIR IN THE TRUNK REGION (AROUND THE AORTA). GIVEN THE HISTORY OF ATRIAL FIBRILLATION ABLATION PROCEDURE, A LEFT ATRIAL¿ESOPHAGEAL FISTULA WAS STRONGLY SUSPECTED. EMERGENCY SURGERY WAS PERFORMED. DESPITE TWO DAYS OF HOSPITALIZATION THEREAFTER, THE PATIENT DID NOT IMPROVE AND DIED DURING ADMISSION. IT WAS REPORTED THAT THE CAUSE OF DEATH W

  Patient problems: Air Embolism; Fistula; Hemorrhage/Blood Loss/Bleeding; Stroke/CVA

  MAUDE report 25670686 ↗
• DeathJun 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT SIDED ATRIAL FLUTTER ABLATION WITH A QDOT MICRO AND THE PATIENT EXPERIENCED CARDIAC ARREST THAT REQUIRED MEDICATION AND CARDIOPULMONARY RESUSCITATION (CPR), HOWEVER, THE PATIENT DIED. IT WAS REPORTED THAT THE PATIENT HAD PRESENTED A MONTH AGO FOR PULSE FIELD ABLATION (PFA) ABLATION, HOWEVER, THE PFA CASE WAS NOT PERFORMED AS THE PATIENT HAD A CLOT IN THE LEFT ATRIAL APPENDAGE AT THE TIME. THE PATIENT WAS BROUGHT BACK IN FOR RADIOFREQUENCY (RF) ABLATION, AFTER BEING ON 4 WEEKS ON MEDICATION. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED TODAY, AND NO CLOT WAS OBSERVED IN THE PATIENT. THEY BELIEVE THE PATIENT'S EJECTION FRACTION (EF) WAS 55 A "FEW DAYS EARLIER," AND THE PATIENT'S "EF" THAT DAY WAS 44. THE PHYSICIAN OBTAINED ACCESS, AND ADVANCED INTO THE RIGHT ATRIUM WITH THE CARTO VIZIGO SHEATH AND THE QDOT MICRO CATHETER TO BEGIN RF ABLATION ALONG THE CAVOTRICUSPID ISHMUS (CTI) LINE. AFTER ABOUT 2-3 MINUTES OF ABLATION ALONG THE CTI LINE WITH THE QDOT MICRO CATHETER, IT WAS NOTICED THAT THE PATIENT BLOOD PRESSURE WAS DROPPING, EVEN WITH AN EXTERNAL PACER BEING UTILIZED. THE PHYSICIAN DECIDED TO TAKE THE PATIENT OFF SEDATION, AN

  Patient problems: Cardiac Arrest

  MAUDE report 25641758 ↗
• DeathJun 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NONISCHEMIC VENTRICULAR TACHYCARDIA ABLATION AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS AND CARDIAC ARREST THAT REQUIRED CPR AND IMPELLA PLACEMENT. THE PATIENT DIED. DURING THE PROCEDURE, ALCOHOL ABLATION WAS PERFORMED INTO A SEPTAL PERFORATOR VEIN AND THE PATIENT CODED AFTER THIS. THE REPORTER STATED THAT CPR (CARDIORESPIRATORY RESUSCITATION) WAS PERFORMED ON THE PATIENT AND AN IMPELLA WAS PLACED AND THE PATIENT STABILIZED AT THIS POINT. THEY CHECKED ON INTRACARDIAC ECHOCARDIOGRAPHY AND CONFIRMED THAT THERE WAS NO EFFUSION, AND THE PATIENT WAS SENT TO THE ICU (INTENSIVE CARE UNIT). AT SOME POINT IN THE NIGHT, THE PATIENT DEVELOPED A PERICARDIAL EFFUSION. THE PATIENT CODED WHILE IN THE ICU AND REQUIRED CPR, THE PATIENT GOT TAMPONADE AND REQUIRED A TAP. THE PATIENT WAS BROUGHT TO THE CATH LAB TO GET TAPPED AND 455 ML WERE DRAINED DURING THE PERICARDIOCENTESIS. AFTER THE TAP WAS COMPLETED, THE PATIENT WAS MOVED TO THE ICU AND WAS STILL UNSTABLE AND THE FAMILY WITHDREW CARE. THEY THINK SOMETHING HAPPENED WHEN THEY DID CPR OR WHEN THEY TRIED TO PLACE THE SWAN-GANZ BEDSIDE DUE TO HAVING DIFFICULTY. RADIOFREQU

  Patient problems: Cardiac Arrest; Cardiac Tamponade

  MAUDE report 25628106 ↗
• MalfunctionApr 6, 2026Insufficient Cooling

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL TACHYCARDIA (AT) 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 CARTO 3 SYSTEM DISPLAYED A "TEMPERATURE SLOPE TOO HIGH" ERROR ON THE NGEN SYSTEM WHEN ABLATION WAS ATTEMPTED. THE CABLE WAS REPLACED WITHOUT RESOLUTION. THE TX ECO CABLE WAS EXCHANGED WITHOUT RESOLUTION. THE CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS CONTINUED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION OF THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 13-MAR-2026, 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 13-MAR-2026 AND HAVE ASSESSED THIS RETURNED CONDITION AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24795617 ↗
• MalfunctionApr 3, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A STEAM POP OCCURRED DURING ABLATION. THERE WERE NO ERRORS DISPLAYED ON THE NGEN MONITOR OR CARTO 3 SYSTEM. THERE WAS NO CHAR ON THE CATHETER. THE PROCEDURE WAS CONTINUED AND COMPLETED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24779734 ↗
• InjuryMar 30, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) RIGHT SIDED ABLATION WITH A QDOT MICRO CATHETER AND THE PATIENT EXPERIENCED PERICARDIAL EFFUSION/CARDIAC HEMATOMA THAT REQUIRED PERICARDIOCENTESIS AND SURGICAL INTERVENTION. MIDWAY THROUGH THE PROCEDURE, THE PHYSICIAN OBSERVED THROUGH INTRACARDIAC ULTRASOUND THAT THE PATIENT HAD DEVELOPED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED (750 CCS WAS REMOVED FROM THE PERICARDIAL SPACE). WHILE OBSERVING THE PATIENT, AFTER 30 MINUTES, THE EFFUSION STARTED TO GROW AGAIN AND MORE FLUID WAS EXTRACTED. THE PATIENT WAS TRANSPORTED TO SURGERY. THE PATIENT HAD SUCCESSFUL SURGERY TO REPAIR A HEMATOMA THAT HAD FORMED IN THE RIGHT VENTRICLE (RV) AND WAS DOING WELL. THE PHYSICIAN STATED THAT HE BELIEVES THE ADVERSE EVENT WAS CAUSED BY EXCESSIVE MANIPULATION OF THE ABLATION CATHETER INSIDE THE RVOT DUE TO ERRATIC BREATHING FROM THE PATIENT AND ECTOPY. IT WAS NOT THE PHYSICIAN¿S OPINION THAT IT OCCURRED DURING ABLATION. THE EXACT PROCEDURAL ACT WAS UNKNOWN BUT THE GOAL WAS TO MAINTAIN AN ACT AT OR ABOVE 350. LESS THAN 10 ABLATIONS WERE PERFORMED WITH RADIOFREQUENCY. NO TRANSSEPTAL PUNCTURE SITE PERFORMED

  Patient problems: Cardiac Tamponade; Hematoma

  MAUDE report 24737844 ↗
• MalfunctionMar 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A QDOT MICRO CATHETER AND DURING ABLATION, A FORCE SENSOR ERROR WAS DISPLAYED. AS A RESULT, IT WAS IMPOSSIBLE TO PROCEED. 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 FORCE TEST OF THE RETURNED DEVICE WERE PERFORMED. VISUAL INSPECTION REVEALED REDDISH MATERIAL, PRESUMABLY BLOOD, AND A HOLE IN THE SURFACE OF THE PEBAX. THIS FINDING IS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24734970 ↗
• InjuryMar 30, 2026Patient Device Interaction Problem

  DURING CARDIAC ABLATION PROCEDURE, THE PATIENT EXPERIENCED COMPLETED AV BLOCK LASTING 15 MINUTES. A TEMPORARY PACEMAKER WAS INSERTED, AND THE PATIENT REQUIRED EXTENDED HOSPITALIZATION. DURING CARDIAC ABLATION PROCEDURE WITH A QDOT MICRO CATHETER, ONCE ABLATION WAS STOPPED, A JUNCTIONAL RHYTHM/COMPLETE AV BLOCK DEVELOPED, AND PACING WAS INITIATED. DURING PACING, THE V WAVE DROPPED TWICE. BY THE TIME THE TEMPORARY PACEMAKER WAS INSERTED, THE RHYTHM HAD RETURNED TO SINUS RHYTHM (THE COMPLETE AV BLOCK HAD LASTED ABOUT 15 MINUTES). THE HOSPITAL STAY WAS EXTENDED FOR OBSERVATION. PATIENT IMPROVED. THE V WAVE DROPPED APPROXIMATELY ONCE EVERY FIVE MINUTES, SUGGESTING POSSIBLE RECOVERY TO MOBITZ TYPE II AV BLOCK. REVIEW OF THE ABLATION CATHETER ELECTRICAL POTENTIAL RECORDED IMMEDIATELY BEFORE CESSATION OF ABLATION SHOWED A SMALL POTENTIAL OCCURRING AT THE SAME TIMING AS THE HIS WAVE ON THE HIS CATHETER. ALTHOUGH THIS SMALL POTENTIAL NEARLY COINCIDED WITH THE CS A WAVE, AN A¿H¿V SEQUENCE WAS SEEN ON THE HIS CATHETER, AND THE PHYSICIAN INFERRED THAT IT WAS LIKELY A HIS WAVE. MAPPING WAS PERFORMED AND THE HIS WAS TAGGED. THE PIVOT SITE WAS IDENTIFIED AND FOUND TO BE APPROXIMATELY 11MM FROM THE

  Patient problems: Heart Block

  MAUDE report 24719130 ↗
• MalfunctionMar 23, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE AND AFTER ABLATING THE LEFT SIDE (PULMONARY VEIN ISOLATION, POSTERIOR WALL ISOLATION), THE QDOT MICRO¿ CATHETER WAS MOVED TO THE RIGHT ATRIUM FOR THE CAVOTRICUSPID ISTHMUS (CTI) LINE, AND WHEN COMING ON ABLATION, THERE WAS A HIGH FORCE READING. THE ABLATION STOPPED. NO ERRORS WERE DISPLAYED. THE CATHETER WAS ZEROED, THEY ATTEMPTED TO ABLATE, AND THE ISSUE PERSISTED. THE PHYSICIAN DECLINED TO REPLACE THE CABLE. THE CATHETER WAS REPLACED AND THE ISSUE RESOLVED. THE CATHETER TIP LOOKED FINE WHEN IT WAS REMOVED FROM THE BODY. 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 FORCE TEST OF THE RETURNED DEVICE WERE PERFORMED. VISUAL INSPECTION REVEALED FOREIGN REDDISH MATERIAL, PRESUMABLY BLOOD INSIDE THE PEBAX, AN ELECTRODE LIFTED AND A WIRE EXPOSED. THIS FINDING IS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24664471 ↗
• MalfunctionMar 16, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER ABLATION PROCEDURE WITH A QDOT MICRO CATHETER AND AN IRRIGATION ISSUE OCCURRED. INITIALLY, THE CARTO 3 SYSTEM WAS DISPLAYING HIGH FORCE READINGS WHEN THE CATHETER WAS INSERTED INTO THE BODY. THE MEDICAL TEAM TRIED REZEROING SEVERAL TIMES WITHOUT RESOLUTION. THEY THEN RESEATED THE CONNECTIONS AND REBOOTED THE NGEN¿ SYSTEM AND THE ISSUE RESOLVED. THEY WERE ABLE TO COMPLETE 3 ABLATIONS BUT THEY NOTICED THE NGEN¿ PUMP WAS GOING 4ML EVEN THOUGH ALL THE SETTINGS WERE CORRECT. THE CATHETER WAS NOT IRRIGATION PROPERLY. THE CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24609772 ↗
• MalfunctionMar 16, 2026Incorrect, 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 REDDISH BROWN MATERIAL INSIDE THE PEBAX AND A SEPARATION BETWEEN PEBAX AND ELECTRODE SECTION. DURING THE PROCEDURE, "HI" FORCE DISPLAYED ON CARTO SYSTEM DURING RADIOFREQUENCY ABLATION. THE MEDICAL TEAM CHANGED THE CABLE AND THE ISSUE WAS NOT RESOLVED. THEY CHANGED THE CATHETER AND RESOLVED THE ISSUE. NO FURTHER DETAILS WERE PROVIDED REGARDING COMPLETION OF THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24608974 ↗
• InjuryMar 11, 2026Patient Device Interaction Problem

  DURING CARDIAC ABLATION PROCEDURE WITH A QDOT MICRO CATHETER, THE PATIENT EXPERIENCED CHEST PAIN AND PERICARDIAL EFFUSION DUE TO CARDIAC PERFORATION TREATED WITH PERICARDIOCENTESIS. THEN, THE PATIENT WENT INTO ASYSTOLE DURING POSITIONING OF A NON-BWI CATHETER TREATED WITH EXTERNAL PACING UNTIL THE PATIENT HEART RHYTHM EVENTUALLY RECOVERED. THE REPORT INDICATED THAT THE PATIENT COMPLAINED OF CHEST PAIN DURING THE PROCEDURE AFTER ABOUT 15 MINUTES OR MORE INTO THE CASE. THE CHEST PAIN WAS BELIEVED TO BE FROM PACING AND THE PROCEDURE CONTINUED. THE PORTED THAT A COUPLE OF MINUTES AFTER THE PATIENT COMPLAINED OF CHEST PAIN, A PERICARDIAL EFFUSION WAS NOTICED AND CONFIRMED USING THE ICE (INTRACARDIAC ECHOCARDIOGRAPHY) CATHETER. THE PERICARDIAL EFFUSION WAS DUE TO CARDIAC PERFORATION. THERE WAS NO PERICARDIAL EFFUSION AT BASELINE. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND 150ML OF FLUID WAS REMOVED. THE PATIENT WAS INTUBATED PRIOR TO PERICARDIOCENTESIS. THE PATIENT ALREADY HAD A LEFT BUNDLE BLOCK FROM THE START OF THE PROCEDURE. THE DECANAV CATHETER AND QDOT CATHETER WERE PULLED BACK TO THE SHEATH AND THE ICE CATHETER REMAINED IN THE RIGHT VENTRICLE. THE PHYSICIAN MAN

  Patient problems: Cardiac Perforation

  MAUDE report 24573809 ↗
• MalfunctionMar 9, 2026Incorrect, Inadequate or Imprecise Result or Readings; 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 HOLE ON THE PEBAX. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT AFTER INSERTING THE CATHETER INTO THE PATIENT'S BODY AND IMMEDIATELY AFTER ABLATION, THE CONTACT FORCE SUDDENLY INCREASED. WHEN THE CATHETER WAS REMOVED FROM THE PATIENT¿S BODY FOR INSPECTION, BLOOD WAS PRESENT INSIDE THE CATHETER. THERE WAS NO DIFFICULTY MANEUVERING THE CATHETER DURING THE WITHDRAWAL. THE CATHETER WAS REPLACED. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S 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 16-FEB-2026, 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 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 24554398 ↗
• InjuryMar 9, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR REENTRANT TACHYCARDIA (AVRT)/WOLFF PARKINSON WHITE (WPW) ABLATION AND THE PATIENT EXPERIENCED COMPLETE HEART BLOCK THAT REQUIRED PACEMAKER INSERTION. IT WAS REPORTED THAT DURING AN ACCESSORY PATHWAY ABLATION, SEPTAL FROM THE RIGHT SIDE, THE PATIENT WENT INTO COMPLETE HEART BLOCK, THOUGH WAS STILL CONDUCTING THROUGH THE ACCESSORY PATHWAY. DURING THE LAST RADIOFREQUENCY (RF) ABLATION WITH QDOT MICRO CATHETER IN Q-MODE AT 30 WATTS, WHICH WAS 1.6 CM AWAY FROM THE HIS. IT WAS NOTICED ON THE GE PRUCKA EP RECORDING SYSTEM THAT THE PATIENT HAD "A FEW BLOCKED BEATS." THE PHYSICIAN IMMEDIATELY STOPPED ABLATING. THEN, SIX (6) SECONDS AFTER THAT LAST ABLATION, THE PATIENT WENT INTO COMPLETE HEART BLOCK. EMERGENT PACING WAS NOT PERFORMED, AS THE PATIENT WAS STILL CONDUCTING THROUGH THEIR PATHWAY, DISPLAYING "LEFT BUNDLE" CONDUCTIVITY ON EKG. THE PATIENT WAS IN STABLE CONDITION AND WAS RECEIVING A PERMANENT PACEMAKER AT THE TIME OF REPORTING.

  Patient problems: Heart Block

  MAUDE report 24551851 ↗
• InjuryMar 9, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A QDOT MICRO AND EXPERIENCED CARDIAC FAILURE. THE REPORT INDICATED THAT AT THE END OF THE AFIB CASE, THE PATIENT'S STATISTICS (STATS) WERE LOW, ALONG WITH LOW BLOOD PRESSURE. THE PATIENT WAS DIAGNOSED WITH ACUTE BIVENTRICULAR FAILURE AT THE END OF THE CASE. THE ACUTE BIVENTRICULAR FAILURE WAS CONFIRMED USING TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE PATIENT WAS CONFIRMED TO HAVE NO PERICARDIAL EFFUSION WITH THE TEE. THE PATIENT WAS MOVED TO INTENSIVE CARE UNIT (ICU). THE LAST KNOWN PATIENT STATUS WAS STABLE. PRIOR TO ABLATION PROCEDURE, AT THE BEGINNING OF THE AFIB CASE WITH RAPID VENTRICULAR RESPONSE (RVR), THE PATIENT WAS CARDIOVERTED AND THE PROCEDURE WAS COMPLETED WITH A QDOT MICRO CATHETER. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT IT WAS DUE TO THE PATIENT¿S AFIB WITH RVR AND CARDIOVERSION AND DID NOT THINK THAT IT HAD ANYTHING TO DO WITH A BIOSENSE WEBSTER INC. (BWI) PRODUCT THAT WAS USED.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 24551124 ↗
• MalfunctionMar 9, 2026Incorrect, 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, THERE WAS A CONTACT FORCE SENSOR ERROR ON THE QDOT. THIS OCCURRED DURING RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) ABLATION, TWO HOURS AFTER THE QDOT MICRO CATHETER USE COMMENCED. RECONNECTION OF THE CABLE AND RESTART OF THE DONGLE DID NOT RESOLVE THE ISSUE. CABLE REPLACEMENT ALSO FAILED TO RESOLVE THE ISSUE. THE QDOT WAS REPLACED AND THE PROCEDURE WAS SUBSEQUENTLY COMPLETED. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24543008 ↗
• MalfunctionMar 2, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A QDOT MICRO MICRO FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE ON THE SURFACE OF THE PEBAX AND INTERNAL PARTS EXPOSED. THE CATHETER HAD FORCE ERROR. AS SOON AS THEY STARTED THE ABLATION, THE FORCE WAS TOO HIGH. THEY TRIED TO DISCONNECT THE CABLE AND THEY CHANGED THE CATHETER. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 06-FEB-2026, OBSERVED A HOLE ON THE SURFACE OF THE PEBAX, REDDISH MATERIAL INSIDE, AND INTERNAL PARTS EXPOSED. THE EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF A HOLE ON THE SURFACE OF THE PEBAX AND INTERNAL PARTS EXPOSED ON 06-FEB-2026 AND HAVE ASSESSED THIS RETURNED CONDITION AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24492270 ↗
• InjuryMar 2, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A QDOT MICRO CATHETER AND SUFFERED A CARDIAC TAMPONADE TREATED WITH DRAINAGE. REQUIRED PROLONGED HOSPITALIZATION. THE REPORT INDICATED THAT AFTER THE PROCEDURE WITH A QDOT CATHETER THE PATIENT EXPERIENCED BLOOD PRESSURE DECREASE. THE BODY SURFACE ECHOCARDIOGRAPHY CONFIRMED INTRACARDIAC FINDINGS CONSISTENT WITH CARDIAC TAMPONADE (AT THE END OF CARTO3 USE). APPROXIMATELY 5 HOURS AFTER THE START OF THE PROCEDURE. CHEST DRAINAGE WAS PERFORMED AND BLOOD PRESSURE AND OTHER VITAL SIGNS RECOVERED. NO EXTENSION OF HOSPITALIZATION. THE VISITAG COLORING SETTING WAS TAG INDEX. THE INFORMATION RECEIVED INDICATED THAT THE EVENT WAS CARDIAC TAMPONADE. THE VITAL SIGNS STABILIZED IN THE CATHETERIZATION ROOM AND THE PATIENT CONDITION IS IMPROVING IN THE WARD. THE PHYSICIAN¿S ASSESSMENT ON HEALTH HAZARD WAS NOT SERIOUS (MODERATE/MILD). THE PATIENT REQUIRED EXTENSION OF HOSPITALIZATION. THE CONTACT FORCE (CF) MONITORING METHODS USED WERE REAL TIME GRAPH, DASHBOARD, VECTOR, AND VISITAG. THE VISITAG ADDITIONAL FILTER USED WAS TARGET TEMP. NO ABNORMALITIES OBSERVED PRIOR/DURING USE OF THE PRODUCT USE. THE OUTCOME OF THE ADVERSE EV

  Patient problems: Cardiac Tamponade

  MAUDE report 24490400 ↗