LASSO NAV D134301Recalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 10846835009637), received between Aug 30, 2017 and Jul 17, 2025 — classified as 2 deaths, 29 injuries, 51 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (19 reports).

1 other recall cover devices cleared under the same FDA submission (K113213); they may or may not involve this specific model.

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 82 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT PRE PULMONARY VEIN ISOLATION (PVI) CARDIAC ABLATION WHILE MAPPING WITH A LASSO NAV CATHETER, THE PATIENT EXPERIENCED A CARDIAC TAMPONADE TREATED WITH A PERICARDIOCENTESIS. PRE PVI ABLATION, WHILE LEFT ATRIUM (LA) MAPPING WITH A LASSO NAV CATHETER, THE CARDIAC RHYTHM STARTED TO RISE. TRANS THORACIC ECHO REVEALED PERICARDIAC TAMPONADE / PERICARDIAL EFFUSION TREATED WITH A PERICARDIAC PUNCTURE/DRAIN, AND 600ML OF BLOOD WAS REMOVED FROM THE PERICARDIUM. THE PHYSICIAN WAS PAYING ATTENTION TO THE VITAL SIGNS BECAUSE THE TRANSSEPTAL PUNCTURE (TSP) WAS NOT EASY, AND THE POSTERIOR ROOF OF THE LA WAS CLOSE TO THE TSP NEEDLE. THE PATIENT IS STABLE FOR NOW. THE SURGERY WAS DELAYED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION OF THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Cardiac Tamponade; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22538519 ↗
• MalfunctionMar 27, 2025Improper or Incorrect Procedure or Method; Device Contamination with Body Fluid; Improper or Incorrect Procedure or Method; Device Contamination with Body Fluid

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A LASSO NAV AND CHAR WAS FOUND ON THE TIP ELECTRODE. AFTER THE INSERTION OF THE CATHETER IN THE LEFT ATRIUM (LA), THE IMPEDANCE OF THE CORRESPONDING SMART TOUCH SF CATHETER RAPIDLY INCREASED DURING RIGHT PULMONARY VEIN ISOLATION (RPVI). WHEN THE CATHETER WAS REMOVED FROM THE PATIENT¿S BODY AND CHECKED, CHARRING WAS OBSERVED ON THE TIP ELECTRODE OF THE CATHETER. THE SMART TOUCH SF CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. FURTHERMORE, TOWARDS THE END OF THE PROCEDURE, WHEN THE CORRESPONDING LASSO 2515 NAV ECO CATHETER WAS REMOVED FROM THE PATIENT¿S BODY, CHARRING WAS OBSERVED, SIMILAR TO THAT SEEN ON THE SMART TOUCH SF CATHETER. ADDITIONAL INFORMATION RECEIVED INDICATED THERE WERE NO ERROR MESSAGES PRESENTED BY THE SYSTEM; IMPEDANCE RAPIDLY INCREASED DURING RPVI. THE GENERATOR WAS SET UP ON POWER CONTROL MODE AND ABLATION NEVER CONTINUED BEYOND THE IMPEDANCE CUT-OFF VALUE. THERE WAS USER MISS OF CHANGING THE CATHETER SETTING ON THE GENERATOR SIDE, AND THE ABLATION WAS CONDUCTED WITH THE 4MM TIP CATHETER SETTING DURING 10 TIMES OF ABLATION AT THE BEGINNING. IRRIGATION FLOW RATE WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21713265 ↗
• InjuryFeb 19, 2025Coagulation in Device or Device Ingredient; Patient Device Interaction Problem; Coagulation in Device or Device Ingredient; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A LASSO NAV WHEREIN A THROMBUS/CLOT WAS FOUND ON THE CATHETER TIP AND THE PROCEDURE WAS CANCELLED. THE PATIENT REQUIRED MEDICINAL INTERVENTION AND HOSPITALIZATION. A CLOT WAS DISCOVERED ATTACHED TO THE LASSO NAV CATHETER IN THE LEFT ATRIUM, WHICH WAS NOTICED ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE CLOT FORMATION WAS DISCOVERED AFTER THE INITIAL MAPPING OF THE LEFT ATRIUM. THE PATIENT WAS GIVEN HEPARIN (A LARGE AMOUNT OF HEPARIN TO DILUTE THE CLOT) AND THE PROCEDURE WAS CANCELLED. THERE WAS NO PATIENT INJURY, HOWEVER, THE PATIENT REQUIRED EXTENDED HOSPITALIZATION AS THE PATIENT NEEDED NEUROLOGY MONITORING. THE PHYSICIAN HAD SOME DIFFICULTY WHEN THEY TRIED TO GO TRANSSEPTAL AND IT TOOK LONGER THAN USUAL. THE PHYSICIAN BELIEVES THAT EITHER THE PATIENT ALREADY HAD A CLOT THAT THEY DIDN'T NOTICE OR THE CLOT WAS CAUSED BY THE 45 MINS IT TOOK TO GO TRANSSEPTAL. IT WAS REPORTED THAT THE PHYSICIAN DOES NOT USE HEPARIN UNTIL POST TRANSSEPTAL, HE ALSO DOES NOT CLEAR THE LEFT ATRIAL APPENDAGE (LAA) WITH "SOUND" (ULTRASOUND). THERE WAS NO ERROR MESSAGE FROM THE EQUIPMENT, NO PRODUCT PROBLEM, OR ANY ISSUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21415057 ↗
• MalfunctionApr 10, 2024Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A LASSO® NAV ECO VARIABLE CATHETER AND THE SPIRAL OF THE CATHETER BROKE. THE LOOP OF THE CATHETER WAS BLOCKED. IT WAS NOT POSSIBLE TO MANIPULATE THE CATHETER. SO THE MEDICAL TEAM CHANGED IT AND EVERYTHING WENT WELL WITH THE REMAINDER OF THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19085017 ↗
• MalfunctionMar 11, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A LASSO® NAV ECO VARIABLE CATHETER. IMMEDIATELY AFTER INSERTION, BECAME INOPERABILITY AT THE TIMING WHEN DECREASED THE RING DIAMETER IMMEDIATELY. THE ISSUE WAS RESOLVED BY REPLACING THE LASSO® NAV ECO VARIABLE CATHETER. PATIENT WAS UNAFFECTED. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED. THERE WAS SOME RESISTANCE. THERE WAS NO RING, ELECTRODE OR OTHER PHYSICAL DAMAGE OBSERVED AT THE DISTAL END OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18882376 ↗
• InjuryMar 5, 2024Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT) CARDIAC ABLATION PROCEDURE WHICH INCLUDED THE USE OF A LASSO® NAV ECO VARIABLE CATHETER AND THE PATIENT EXPERIENCED ATRIAL FIBRILLATION (AFIB) TREATED WITH CARDIOVERSION. IT WAS REPORTED THAT WHEN INSERTING THE LASSONAV CATHETER, THE PATIENT WENT INTO AFIB. THE PHYSICIAN FEELS THAT THE ISSUE IS RELATED TO THE CATHETER FREQUENCIES ON THE CARTO 3 SYSTEM. PATIENT HAS FULLY RECOVERED.

  Patient problems: Atrial Fibrillation

  MAUDE report 18840804 ↗
• MalfunctionFeb 25, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A LASSO® NAV ECO VARIABLE CATHETER AND THE TORQUE TO CONTROL THE LOOP FAILED. AFTER MAPPING WITH THE LASSO® NAV ECO VARIABLE CATHETER, HE TRIED TO RELEASE THE LOOP AND PUT IT IN VEIN TO CHECK THE SIGNAL FOR ABLATION, BUT THE TORQUE TO CONTROL THE LOOP FAILED, SO HE WAS ABLE TO REPLACE IT WITH A NEW CATHETER AND SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18775156 ↗
• InjuryJan 17, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER AND LASSO® NAV ECO VARIABLE CATHETER. THE PATIENT EXPERIENCED A CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. CARDIAC TAMPONADE OCCURRED. PUNCTURE WAS PERFORMED AND THE CORONARY SINUS CATHETER WAS PLACED THROUGH THE NECK. BROCKEN BROUGH WAS PERFORMED. AFTER "SS MERGE" AND PRE MAP WERE PERFORMED IN THE LEFT ATRIUM (LA), HYPOTENSIVE WAS FOUND. DRAINAGE WAS PERFORMED. DURING THE DRAINAGE, PULMONARY VEIN ISOLATION (PVI) WAS PERFORMED. AFTER ONLY PVI, THE ABLATION WAS TERMINATED. PROLONGED DRAINAGE COULD NOT STABILIZE THE PATIENT¿S CONDITION VERY MUCH. THE TIMING WAS AFTER TWO HOURS FROM THE ROOM ENTRY. THE PATIENT LEFT THE ROOM FOR A CT SCAN. THE CAUSE WAS UNKNOWN. PHYSICIAN ASSESSMENT OF THE HEALTH PROBLEM WAS SERIOUS. THERE WERE NO ABNORMALITIES OBSERVED BEFORE USING THE PRODUCT AND WHILE USING THE PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE EVENT OCCURRED DURING THE MAPPING PHASE. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH RF NEEDLE. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT COULD NOT BE DETERMINED, BUT IT WAS POSSIBLY PROCEDURE RELA

  Patient problems: Cardiac Tamponade

  MAUDE report 18531990 ↗
• MalfunctionJan 16, 2024Material Twisted/Bent; Mechanical Jam; Material Twisted/Bent; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A LASSO® NAV ECO VARIABLE CATHETER AND THE DEVICE BECAME STUCK WITHIN ITSELF. LASSO GOT STUCK ON ITSELF. WOULDN'T COME INTO SHEATH OR OUT OF CHAMBER. IT WAS STUCK IN BOTH WIDE AND SMALL POSITION BUT THE KNOB WAS STILL FREE MOVING. WHEN REMOVED AND EXAMINED THE SHAFT SEEMED TO BE DAMAGED. DAMAGE TO THE BASE OF THE LASSO LOOP. LOOKS LIKE IT WAS EXTREMELY TORQUED AND DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18523150 ↗
• InjuryOct 16, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE USING A LASSO NAV CATHETER. THE PATIENT EXPERIENCED PERICARDIAL EFFUSION THAT REQUIRED PROLONGED HOSPITALIZATION AND PROCEDURE CANCELLATION. AFTER A FAST ANATOMICAL MAPPING (FAM) OF THE LEFT ATRIUM (LA) WAS COMPLETED WITH THE LASSO CATHETER, THE PHYSICIAN NOTICED THAT THERE WAS A PERICARDIAL EFFUSION ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE EFFUSION WAS NOT PRESENT AT THE START OF THE PROCEDURE (VERIFIED WITH ICE). AS A PRECAUTION, THE PHYSICIAN PREFERRED TO STOP THE PROCEDURE WITHOUT ANY ABLATION THE PROCEDURE WAS TERMINATED. THE EFFUSION WAS MONITORED AND DID NOT WORSEN. THE PATIENT WAS IN STABLE CONDITION. THE PATIENT DID NOT REQUIRE A PERICARDIAL DRAIN AND RECOVERED WITHOUT FURTHER INTERVENTION. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION AND WAS MONITORED OVERNIGHT. PATIENT HAS FULLY RECOVERED. THE PHYSICIAN DOES NOT BELIEVE THE COMPLICATION IS RELATED TO ANY BIOSENSE WEBSTER CATHETERS. HE THINKS IT MAY HAVE OCCURRED DURING THE TRANSSEPTAL PUNCTURE. EVENT OCCURRED AFTER THE TRANSSEPTAL PHASE, AFTER THE LA MAPPING PHASE, BEFORE THE ABLATION PHASE. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH BAYL

  Patient problems: Pericardial Effusion

  MAUDE report 17945164 ↗
• MalfunctionMay 30, 2023Communication or Transmission Problem; Electrical Shorting; Communication or Transmission Problem; Electrical Shorting

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND A LASSO® NAV ECO VARIABLE CATHETER, AND A BAD NO ECG SIGNAL ON ALL CHANNELS OCCURRED. INITIALLY, IT WAS REPORTED THAT THE CARTO 3 SYSTEM DISPLAYED AN UNKNOWN ERROR WITH A NOTIFICATION OF "CURRENT LEAKAGE ERROR. WHEN THEY DISCONNECTED THE CATHETERS FROM THE PIU, THE ISSUE WAS RESOLVED. HOWEVER, THE ISSUE REOCCURRED WHEN CONNECTING THE PENTARAY CATHETER AND THE LASSO CATHETER TO THE PIU. THEY REPLACED THE LASSO CATHETER AND THE PENTARAY CATHETER AT THE SAME TIME AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS CONTINUED, AND NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. THE CURRENT LEAKAGE IS NOT MDR REPORTABLE. THIS ISSUE IS HIGHLY DETECTABLE AND REQUIRES ADJUSTING SYSTEM COMPONENTS TO CONTINUE WITH THE PROCEDURE. DEVICES MAY REQUIRE RESET OR REPLACING BUT CANNOT BE USED ON THE PATIENT. PATIENT SAFETY IS UNAFFECTED BY THIS ISSUE. ON 03-MAY-2023, ADDITIONAL INFORMATION WAS RECEIVED WHICH MADE THE EVENT REPORTABLE. IT WAS CONFIRMED THAT THE NOTIFICATION WAS ACCOMPANIED BY A LOSS OF ALL ECGS. THE NOISE WAS OBSERVED ON ALL CHANNELS, ON BOTH THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17027846 ↗
• MalfunctionMay 1, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A PATIENT UNDERWENT A AFIB - PERSISTENT ABLATION PROCEDURE WITH A LASSO® NAV ECO VARIABLE CATHETER . IT WAS REPORTED THAT DURING MAPPING OF THE LEFT ATRIA, THE LASSO NAV CATHETER ENTANGLED WITH A CHORDAE OF THE MITRAL VALVE. IT TOOK A GREAT DEAL OF EFFORT AND TIME FOR THE PHYSICIAN TO MANAGE TO REMOVE THE CATHETER FROM THE VALVE'S CHORDAE. SURGERY WAS DELAYED DUE TO THE REPORTED EVENT FOR 60 MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES WERE REPORTED. THE EVENT HAPPENED ON THE SAME DAY WITH THE CURRENT COMPLAINT: (B)(6) 2023. THIS ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. THE PATIENT DID NOT SUFFER ANY NOTABLE CONSEQUENCE; HOWEVER, THE PROCEDURE WAS DELAYED ALMOST AN HOUR AND IF THE HOSPITAL SURGERY DEPARTMENT WAS READY TO INTERVENE IF THE PHYSICIAN WAS NOT ABLE TO REMOVE THE CATHETER FROM THE CHORDAE. THE PHYSICIANS OPINION ON THE EVENT IS THAT THE PRODUCT WAS SOMEHOW "PRONE TO HANGING.". THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION. MEDICAL DEVICE ENTRAPMENT WITH EXCESSIVE MANIPULATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16845148 ↗
• InjuryApr 13, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE THAT INCLUDED THE USE OF LASSO® NAV ECO VARIABLE CATHETER AND THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. IT WAS REPORTED THAT THE BLOOD PRESSURE DECREASED RAPIDLY WHILE MAPPING AT LEFT ATRIUM (LA) WITH THE LASSO® NAV ECO VARIABLE CATHETER. ECHOCARDIOGRAPHY WAS PERFORMED AND PERICARDIAL EFFUSION WAS CONFIRMED. DRAINAGE WAS PERFORMED (APPROXIMATELY 500ML OF BLOOD), HEMOSTASIS WAS ACHIEVED. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). THE PROCEDURE WAS DISCONTINUED. TRANSSEPTAL PUNCTURE WAS PERFORMED. ABLATION WAS NOT PERFORMED. STEAM POP WAS NOT CONFIRMED. IRRIGATION CATHETER¿S FLOW RATE SETTING: DEFAULT SETTING. THERE WERE NO ABNORMALITIES OBSERVED PRIOR TO AND DURING USE OF THE PRODUCT. THE EVENT OCCURRED DURING THE MAPPING PHASE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. THE OUTCOME OF THE ADVERSE EVENT WAS PATIENT FULLY RECOVERED (NO RESIDUAL EFFECTS). THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. PUMP WAS SWITCHING FROM ¿LOW¿ TO ¿HIGH¿ FLOW DURING ABLATION. NO ERROR MESSAGES OBSERVED ON BIO

  Patient problems: Cardiac Tamponade

  MAUDE report 16739390 ↗
• InjuryMar 21, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A LASSO® NAV ECO VARIABLE CATHETER AND THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT WHEN LEFT INFERIOR PULMONARY VEIN (LIPV) AND LEFT SUPERIOR PULMONARY VEIN (LSPV) WERE COOLED IN CRYO ABLATION, THE PATIENT SAID THAT THEY FELT SICK, AND THE BLOOD PRESSURE BEGAN TO DECREASE. WHEN THE ECHO WAS APPLIED, THERE WAS AN ACCUMULATION OF PERICARDIAL EFFUSION. THEN, THE CONDITION FURTHER WORSENED WHILE THE DRAINAGE WAS BEING PREPARED, SO CARDIAC MASSAGE AND PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS) WERE PERFORMED. BECAUSE ABOUT 500 ML OF BLOOD WAS WITHDRAWN BY DRAINAGE, BLOOD TRANSFUSION WAS ALSO PERFORMED. AFTER PERFORMING PCPS, THE CONDITION BECAME STABLE, THE PATIENT LEFT THE ROOM AND WENT TO INTENSIVE CARE UNIT (ICU). THE PROCEDURE WAS INTERRUPTED. ATRIAL SEPTAL PUNCTURE WAS PERFORMED BY RF NEEDLE. STEAM POP WAS NOT CONFIRMED; THERE WAS NO EVIDENCE OF STEAM POP. IRRIGATION CATHETER WAS NOT USED. THERE WAS NO COMMENT PARTICULARLY ON THE RELATIONSHIP WITH THE PRODUCT. THERE WERE NO ABNORMALITIES OBSERVED PRIOR TO OR DURI

  Patient problems: Cardiac Tamponade

  MAUDE report 16582098 ↗
• MalfunctionMar 3, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A LASSO® NAV ECO VARIABLE CATHETER AND A CATHETER SHAFT BROKEN ISSUE OCCURRED. IT WAS REPORTED THAT ¿BROKEN MID CASE¿. AN ATTEMPT WAS MADE TO GET FURTHER CLARIFICATION; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE REGARDING THIS EVENT. THE CATHETER SHAFT BROKEN ISSUE IS MDR REPORTABLE TO THE FDA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16481946 ↗
• InjuryMar 1, 2023Signal Artifact/Noise; Patient Device Interaction Problem; Signal Artifact/Noise; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A LASSO® NAV ECO VARIABLE CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. IT WAS REPORTED THAT A SIGNAL NOISE OCCURRED AT THE LASSO® NAV ECO VARIABLE CATHETER 15-16. TIMING WHEN COMPLAINTS OCCURRED WAS IMMEDIATELY AFTER CARDIAC INSERTION. THE CABLE WAS CHANGED BUT THE ISSUE CONTINUED. THE ISSUE WAS RESOLVED BY CHANGING THE LASSO® NAV ECO VARIABLE CATHETER TO ANOTHER ONE. THE PROCEDURE WAS CONTINUED. NOISE AND ELECTRICAL POTENTIAL LOSS: NOISE AND POTENTIAL LOSS OCCURRED. IN INTRACARDIAC ONLY, BOTH CARTO3 AND LAB, THE CATHETER WAS IN THE PATIENT¿S BODY AT THE TIME OF THE NOISE. DURING LEFT ATRIUM (LA)-MAPPING, BLOOD PRESSURE DECREASED, AND DRUGS WERE INJECTED, BUT ONLY PULSE INCREASED. PERICARDIAL EFFUSION WAS CONFIRMED BY ECHOCARDIOGRAPHY. THEREAFTER, DRAINAGE WAS PERFORMED. 800 CC OF VENOUS BLOOD WAS DRAINED. HEMODYNAMICS WAS IMPROVED, AND THE PATIENT WAS FOLLOWED UP IN THE INTENSIVE CARE UNIT (ICU). CARDIAC TAMPONADE: ATRIAL SEPTAL PUNCTURE WAS PERFORMED BY RF NEEDLE. ABLATION WAS NOT PERFORMED. STEAM POP WAS NOT CONFIRMED. THE PHYSICIAN'S OPINIONS ON THE RELATIONSHIP BETWEEN THE EVE

  Patient problems: Cardiac Tamponade

  MAUDE report 16463925 ↗
• InjuryJan 24, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  A MALE PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A LASSO NAV 2515,22P SPLITHANDLE CATHETER. THE PATIENT EXPERIENCED CARDIAC TAMPONADE AND TREATED WITH PERICARDIAL DRAINAGE. DURING CRYOABLATION PROCEDURE, SOUNDSTAR ECO CATHETER AND LASSO 2515 NAV ECO CATHETER WERE USED, AND CARTO3 WAS USED AS A CONCOMITANT PRODUCT. CAVOTRICUSPID ISHMUS (CTI) ABLATION WAS ALSO CONDUCTED WITH FREEZER MAX. CARDIAC TAMPONADE OCCURRED AFTER PVI AND CTI. THE PHYSICIAN COMMENTED THAT IT WAS UNKNOWN WHETHER THE ADVERSE EVENT WAS RELATED TO THE BW PRODUCT. THERE WAS NO PRODUCT MALFUNCTION. THE COMPLAINT PRODUCT(S) WILL NOT BE RETURNED FOR ANALYSIS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS PATIENT CONDITION. THE PHYSICIAN COMMENTED THAT NO BW PRODUCT MALFUNCTION OBSERVED AND AE WAS NOT RELATED TO THE PRODUCT. THE PHYSICIAN ALSO COMMENTED THAT IT MIGHT BE RELATED TO THE PATIENT ALTHOUGH THE CAUSE OF THE AE WAS UNKNOWN. THE OUTCOME IS THE PATIENT HAS FULLY RECOVERED. THE PATIENT WAS RECOVERED AND HAS BEEN DISCHARGED FROM THE HOSPITAL, BUT THE DISCHARGED DATE WAS UNKNOWN. NO EXTENDED HOSPITALIZATION WAS REQUIRED. TRANSSEPTAL PUNCTURE PERFORMED WITH RF NEEDLE. PRIOR TO NOTING THE P

  Patient problems: Cardiac Tamponade

  MAUDE report 16231492 ↗
• MalfunctionJan 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A LASSO® NAV ECO VARIABLE CATHETER AND THE TIP FULLY SEPARATED. IT WAS REPORTED THAT WHEN THE PACKAGE WAS OPENED, THE OPERATORS NOTICED THAT THE BLUE DISTAL TIP WAS SEPARATED FROM THE REST OF THE CATHETER. THE CATHETER WAS NOT USED ON THE PATIENT. IT WAS PUT ASIDE AND THE PROCEDURE CONTINUED WITH A SIMILAR DEVICE. ADDITIONAL INFORMATION WAS RECEIVED. THE DAMAGE RESULTED IN WIRES BEING EXPOSED BUT DID NOT RESULT IN ANY LIFTED OR SHARP RINGS. THE CATHETER WAS NOT INSERTED IN THE PATIENT. THE ISSUE WAS FOUND WHEN THE CATHETER WAS EXTRACTED FROM THE BOX, THE DISTAL END WAS SEPARATED FROM THE REST. PICTURES WERE PROVIDED. CATHETER WAS NOT PRE-SHAPED. SHEATH INFORMATION NOT AVAILABLE. THE EVENT WAS ASSESSED AS MDR REPORTABLE FOR A TIP FULLY SEPARATED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16129009 ↗
• MalfunctionAug 25, 2022Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A AFIB ¿ PAROXYSMAL ABLATION PROCEDURE WITH A LASSO® NAV ECO VARIABLE CATHETER & 20 POLE ECO CABLE. THERE WAS SIGNAL INTERFERENCE ON BODY SURFACE (BS) AND INSTRACARDIAC (IC) CHANNELS, AND THE PHYSICIAN DID NOT HAVE INTACT ECG SIGNAL AVAILABLE TO MONITOR THE PATIENT. IT WAS REPORTED THAT THERE WAS NOISE DISPLAYED ON ELECTRODES 13-14 ON THE CARTO 3 SYSTEM WHEN THE CATHETER WAS PLUGGED INTO THE PATIENT INTERFACE UNIT. THE NOISE THEN LEAKED ACROSS ALL ECG'S. THE CABLE WAS REPLACED BUT THE ISSUE DID NOT RESOLVE. THE ECO DONGLE WAS REPLACED AND SOME OF THE NOISE CLEARED. THE CATHETER WAS REPLACED, AND THE ISSUE FULLY RESOLVED, CASE CONTINUED. THE PARTS ARE AVAILABLE FOR RETURN. BASED ON THE INITIAL INFORMATION AVAILABLE, THE EVENT WAS ASSESSED AS NOT REPORTABLE AS IT WAS BELIEVED THE PATIENT'S HEART RHYTHM WAS STILL VISIBLE TO THE OPERATOR. ON 28-JUL-2022, BIOSENSE WEBSTER INC (BWI) RECEIVED ADDITIONAL INFORMATION INDICATING SIGNAL INTERFERENCE WAS ON BOTH THE BS AND IC CHANNELS AND THE SIGNAL INTERFERENCE (NOISE) WAS OBSERVED ON BOTH CARTO® AND RECORDING SYSTEM. THE PHYSICIAN DID NOT HAVE ANY INTACT ECG SIGNAL AVAILABLE TO MONITOR PATIENT HEART R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15292105 ↗
• MalfunctionAug 22, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A LASSO® NAV ECO VARIABLE CATHETER AND A BROWN STAIN WAS FOUND ON THE INSIDE OF THE PACKAGE. IT WAS REPORTED THAT A BROWN STAIN WAS FOUND ON THE INSIDE OF THE PACKAGE BEFORE OPENING THE CATHETER. THE CATHETER WAS NOT USED AND WAS RESOLVED BY USING ANOTHER CATHETER FROM A DIFFERENT LOT. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. WITH THE INFORMATION AVAILABLE, THIS ISSUE WAS ASSESSED AS A MDR REPORTABLE PRODUCT MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15263729 ↗
• MalfunctionJun 15, 2022Separation Problem; Separation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A LASSO® NAV ECO VARIABLE CATHETER. THE DOCTOR REPORTED THAT IT FELT LIKE THE CATHETER BROKE. THE PHYSICIAN INSERTED THE LASSO CATHETER INTO THE PATIENT AND THE PHYSICIAN FELT SOMETHING HAS SNAPPED IN THE CATHETER. THE DOCTOR STATED ¿FELT THE CATHETER BREAK¿. NO KNOWN WIRES WERE EXPOSED AND NO SHARP RINGS. THERE WAS NO RESISTANCE OR DIFFICULTY DURING INSERTION OR REMOVAL OF THE CATHETER. THE CATHETER WAS NOT PRE SHAPED AND A BAYLIS 8.5FR SHEATH WAS USED. THE CATHETER WAS REPLACED, AND THE ISSUE WAS RESOLVED. THERE WAS NO PATIENT HARM REPORTED. THIS ISSUE WAS ASSESSED AS A MDR REPORTABLE PRODUCT MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14692797 ↗
• MalfunctionMay 20, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT AN UNKNOWN PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A LASSO® NAV ECO VARIABLE CATHETER. THE CONTRACTION WAS STUCK. THE LASSO CATHETER WOULD NOT OPEN UP AND THE LASSO APPEARED TO BE STUCK. THEY REPLACED THE CATHETER AND THE ISSUE WAS RESOLVED. NO PATIENT CONSEQUENCES WERE REPORTED. THE KNOB AND PISTON WORKED, THE LASSO ITSELF WOULD NOT OPEN OR CLOSE. THE FAILURE WAS FOUND DURING USE. THERE WAS NO DIFFICULTY IN REMOVING THE CATHETER FROM BODY. THERE WAS NO RINGS, ELECTRODE OR OTHER PHYSICAL DAMAGE OBSERVED AT THE DISTAL END OF THE CATHETER. NO ADDITIONAL PROCEDURE WAS REQUIRE TO REMOVE THE CATHETER. CONTRACTION STUCK IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14460558 ↗
• InjuryMay 3, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT ((B)(6)) UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A LASSO® NAV ECO VARIABLE CATHETER AND THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS AND SURGICAL INTERVENTION. AFTER MAPPING THE HEART THE PATIENT BECAME HYPOTENSIVE. A CARDIAC TAMPONADE WAS NOTED BY USING ULTRASOUND. A PERICARDIOCENTESIS WAS PERFORMED AND OVER 2000ML OF FLUID WAS WITHDRAWN AND THEN TRANSFUSED. THE PATIENT WAS THEN SENT TO SURGERY. BIOSENSE HARDWARE WORKED WITHIN SPECIFICATIONS AND THE CALLER DOES NOT REQUEST EVALUATION OF HARDWARE SYSTEMS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THE ADVERSE EVENT WAS THE PATIENT HAD VERY THIN TISSUE IN LEFT ATRIAL APPENDAGE (LAA), THE LASSO PUSHED THROUGH IT WHEN THE CATHETER FELL INTO THE APPENDAGE. THE PATIENT OUTCOME WAS FULLY RECOVERED (NO RESIDUAL EFFECTS). THE PATIENT HAD TO GO TO CARDIOTHORACIC (CT) SURGERY AND HAVE THE LAA PERFORATION CLOSED. THERE WAS NO ABLATION DONE PRIOR TO THE HYPOTENSION AND CARDIAC TAMPONADE. THE PERFORATION WAS CAUSED BY THE LASSO CATHETER WHICH WAS CONFIRMED BY THE CT SURGEON AND EP DOCTOR. A SMARTABLATE GENERATOR WAS USED DURING THIS CASE. A TRANSSEPTAL PU

  Patient problems: Cardiac Tamponade

  MAUDE report 14266683 ↗
• InjuryApr 15, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AN (B)(6) MALE PATIENT ((B)(6)) UNDERWENT AN ATRIAL FIBRILLATION ABLATION AND LEFT ATRIAL APPENDAGE OCCLUSION (WATCHMEN) PROCEDURE WITH A LASSO® NAV ECO VARIABLE CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS, SURGICAL INTERVENTION AND PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION AND LEFT ATRIAL APPENDAGE OCCLUSION WATCHMEN CASE, A PERFORATION TO THE LEFT ATRIAL APPENDAGE, AND A PERICARDIAL EFFUSION WERE NOTICED IN THE PATIENT. THERE WAS A DROP IN BLOOD PRESSURE ON THE PATIENT. THE LEFT ATRIAL APPENDAGE PERFORATION AND THE PERICARDIAL EFFUSION WERE CONFIRMED VIA THE ICE ULTRASOUND SYSTEM. THE MEDICAL INTERVENTION PROVIDED TO THE PATIENT WAS A PERICARDIOCENTESIS. SOME OF THE FLUID REMOVED WAS TRANSFUSED BACK INTO THE PATIENT, BUT ABOUT 2000CC OF FLUID WAS REMOVED. THE PROCEDURE WAS CONTINUED, AND THEY PROCEEDED TO PLACE THE WATCHMEN DEVICE IN THE PATIENT TO CLOSE THE LEAK. HOWEVER, AFTER BEING UNSUCCESSFUL IN CLOSING THE LEAK WITH THE WATCHMEN DEVICE, OPEN HEART SURGERY WAS PERFORMED ON THE PATIENT. THE PATIENT WAS IN STABLE CONDITION AT THE TIME OF REPORTING. THE PHYSICIAN BELIEVED THAT THE CAUSE OF THE ADV

  Patient problems: Cardiac Tamponade

  MAUDE report 14116796 ↗
• InjuryApr 5, 2022Entrapment of Device; Patient Device Interaction Problem; Entrapment of Device; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A LASSO® NAV ECO CATHETER AND THE CATHETER GOT STUCK ON THE MITRAL VALVE REQUIRING SURGICAL INTERVENTION. DURING THE MAPPING PHASE, THE LASSO CATHETER GOT STUCK ON THE MITRAL VALVE. THE PROCEDURE HAD TO BE INTERRUPTED AND THE PATIENT UNDERWENT SURGERY TO REMOVE THE CATHETER. THE PATIENT¿S MITRAL ANNULUS WAS REMOVED AND A BIOLOGICAL VALVE WAS IMPLANTED. THE LASSO® NAV ECO CATHETER GOT STUCK IN CONTRACTED POSITION; THE PHYSICIAN WASN¿T ABLE TO UNFOLD IT. IT IS UNKNOWN IF THE KNOB/PISTON WAS ABLE TO BE TURNED AND/OR PUSHED UP AND DOWN. THE PATIENT HAD TO UNDERGO SURGERY IN ORDER TO REMOVE THE CATHETER FROM HIS HEART. THE SHEATH USED WAS A HEARTSPAN 71CM. THE ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WAS NOT SUCCESSFULLY COMPLETED. THE PATIENT HAD TO BE TRANSFERRED IN ORDER TO UNDERGO A SURGERY. HIS MITRAL VALVE HAD TO BE REPLACED BY A BIOLOGICAL VALVE PROSTHETIST. THE PATIENT¿S OUTCOME FROM THE ADVERSE EVENT WAS REPORTED AS UNCHANGED.

  Patient problems: Rupture

  MAUDE report 14017516 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113213. One submission often covers many models, so check the product and lot details in each record.

• Z-1617-2013 · Jun 19, 2013 · Terminated
  20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysiological mapping of the atria of the heart.