Lasso NAV D134302Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10846835009644), received between Dec 15, 2017 and Aug 15, 2024 — classified as 11 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A LASSO NAV AND THE LASSO CAPACITY TO CHANGE THE CURVE WAS BROKEN. THE PHYSICIAN COULD NOT MOVE IT. THEY HAD TO EXCHANGE THE CATHETER. NO PATIENT CONSEQUENCE WAS REPORTED. WITH THE INITIAL INFORMATION RECEIVED, THIS EVENT WAS ASSESSED AS NOT MDR REPORTABLE. HOWEVER, ON 22-JUL-2024, ADDITIONAL INFORMATION WAS RECEIVED WHICH MADE THE EVENT MDR REPORTABLE WITH AN AWARENESS DATE OF 22-JUL-2024. IT WAS REPORTED THAT DURING THE PROCEDURE, THE LASSO COULD NO LONGER BE FOLDED BACK (LOCKED IN THE OPEN POSITION). ACCORDING TO THE DOCTOR, THIS MADE HANDLING TOO COMPLICATED, WHICH IS WHY THE PROBE HAD TO BE CHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19997251 ↗
• MalfunctionFeb 29, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A LASSO® NAV ECO VARIABLE CATHETER AND THE PRODUCT WAS FULL OF BLOOD ON THE OUTSIDE. A REQUEST FOR CLARIFICATION IS BEING REQUESTED. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18808852 ↗
• InjuryMar 24, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AFIB - PAROXYSMAL ABLATION PROCEDURE INVOLVING A LASSO® NAV ECO VARIABLE CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. IT WAS REPORTED THAT DURING THE PROCEDURE, THE DOCTOR SAID THAT THE CATHETER CURVE WAS BROKEN. SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. ACTION TAKEN WHEN EVENT OCCURRED WAS TO CHANGE CATHETER. PROCEDURE WAS NOT SUCCESSFULLY COMPLETED. IT WAS ALSO REPORTED THAT THERE WAS CARDIAC TAMPONADE AND PERICARDIAL PUNCTURE WAS PERFORMED. ADDITIONALLY, IT WAS REPORTED THIS ADVERSE EVENT DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS PROCEDURE RELATED. INTERVENTION PROVIDED WAS EPICARDIAL PUNCTURE. TRANSSEPTAL PUNCTURE PERFORMED WITH 301803M PREFACE. ABLATION WAS NOT PERFORMED PRIOR TO NOTING THE CARDIAC TAMPONADE; THEREFORE, NO EVIDENCE OF STEAM POP. EVENT OCCURRED DURING MAPPING PHASE. THE FLOW SETTING FOR THE IRRIGATED CATHETER WAS 40W 2CC-15CC. CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. PUMP WAS SWITCHING FROM ¿LOW¿ TO ¿HIGH¿ FLOW DURING ABLATION. FORCE VISUALIZATION FEATURES USED WERE VECTOR AND VISITAG. NO ADD

  Patient problems: Cardiac Tamponade

  MAUDE report 16616269 ↗
• MalfunctionOct 8, 2021Mechanical Jam; Positioning Problem; Mechanical Jam; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A LASSO® NAV ECO VARIABLE CATHETER AND THE CATHETER WAS STUCK IN FULLY CONTRACTED POSITION. INITIALLY, IT WAS REPORTED THAT THE CATHETER WAS NOT STEERABLE. THE CATHETER WAS NOT DEFLECTABLE, AND THE LOOP COULD NOT CHANGE IN RADIUS. THE PROCEDURE WAS DELAYED BY FOUR MINUTES DUE TO THE REPORTED EVENT. THE CATHETER WAS CHANGED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. ON 04-OCT-2021, ADDITIONAL INFORMATION WAS RECEIVED, AND THE REPORTER WAS NOT CERTAIN IF THE LOOP OF THE CATHETER WAS STUCK/JAMMED IN A FULL CONTRACTED POSITION; HOWEVER, THE REPORTER SUGGESTED THAT IT WAS IN FULL CONTRACTED POSITION. IT WAS REPORTED THAT THEY WERE ABLE TO TURN AND PUSH THE KNOB; HOWEVER, THERE WAS NO MOVEMENT AT THE LOOP. THERE WERE NO COMPLICATIONS OR DIFFICULTY IN REMOVING THE CATHETER. THE CONTRACTION STUCK ISSUE WAS ASSESSED AS A MDR REPORTABLE PRODUCT MALFUNCTION AS THE MALFUNCTION OF THE DEVICE CAN POTENTIALLY BE RELATED TO A SERIOUS INJURY. THEREFORE, THE AWARENESS DATE IS 04-OCT-2021. THE DEFLECTION ISSUE WAS ASSESSED AS NOT A MDR REPORTABLE ISSUE AS THE MOST LIKELY CONSEQUENCE IS AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12599788 ↗
• MalfunctionAug 3, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT AN UNKNOWN PATIENT UNDERWENT AN UNKNOWN ABLATION PROCEDURE WITH A LASSO® NAV ECO VARIABLE CATHETER. THE CATHETER'S TIP WAS BROKEN INSIDE THE LASSO LOOP AND COULD NOT ADVANCE INTO THE VESSELS. NO PATIENT CONSEQUENCES. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THE MEDICAL DEVICE ENTRAPMENT (INABILITY TO ADVANCE) IS NOT MDR-REPORTABLE. THE BROKEN TIP IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12264630 ↗
• MalfunctionJul 22, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A LASSO¿ NAV ECO VARIABLE CATHETER AND AN ISSUE WITH THE CATHETER BEING STUCK IN A FULLY CONTRACTED POSITION OCCURRED. THE SMARTTOUCH CATHETER GOT STUCK SEVERAL TIMES IN THE LASSO. INSTEAD OF PULLING BACK ST, LASSO MOVED WITH A LOT OF FORCE. THE LASSO STOPPED CURVING THE WAY IT SHOULD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12215339 ↗
• MalfunctionJun 29, 2021Mechanical Jam; Positioning Problem; Mechanical Jam; Positioning Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PAROXYSMAL ABLATION PROCEDURE WITH A LASSO® NAV ECO VARIABLE CATHETER AND THE BIOSENSE WEBSTER INC, (BWI) PRODUCT ANALYSIS LAB CONDUCTED A DEFLECTION TEST AND THE DEFLECTION MECHANISM OF THE DEVICE WAS FOUND STUCK. INITIALLY, IT WAS REPORTED THAT THE CATHETER LASSO CURVE D PRESENTED A FAILURE IN THE UNIDIRECTIONAL CURVE (DEFLECTION WOULDN'T ANSWER TO COMMAND IN THE HANDLE). IT WAS REPLACED BY A PENTARAY CATHETER CURVE D. AS THE FAILURE WAS FULLY MITIGATED, THE PROCEDURE WAS COMPLETED WITHOUT DELAY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED THE DEFLECTION ISSUE WAS ASSESSED AS NOT MDR REPORTABLE. THE MOST LIKELY CONSEQUENCE IS AN INTRAPROCEDURAL DELAY. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH IS REMOTE. THIS EVENT IS BEING REPORTED BECAUSE THE BIOSENSE WEBSTER INC, (BWI) PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND ON 6/1/2021, THE DEFLECTION MECHANISM OF THE DEVICE WAS FOUND STUCK. THIS FINDING WAS ASSESSED AS MDR REPORTABLE. THEREFORE, THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING IS 6/1/2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12086086 ↗
• MalfunctionMar 16, 2021Entrapment of Device; Mechanical Jam; Entrapment of Device; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A LASSO® NAV ECO VARIABLE CATHETER AND A CONTRACTION STUCK ISSUE OCCURRED. DURING THE PROCEDURE, THE LASSO® NAV ECO VARIABLE CATHETER GOT STUCK WHILE MOVING. THE CATHETER WAS NOT CHANGED AND THE PROCEDURE COULD BE COMPLETED WITH NO PATIENT CONSEQUENCES. ADDITIONAL CLARIFICATION WAS RECEIVED ON THE EVENT. THE LOOP OF THE LASSO® NAV ECO VARIABLE CATHETER GOT STUCK IN A FULLY CONTRACTED POSITION. THE KNOB/PISTON WAS UNABLE TO BE PUSHED UP AND DOWN. THERE WAS NO DIFFICULTY ON REMOVING THE CATHETER FROM THE PATIENT¿S BODY. THE EVENT WAS ASSESSED AS A MDR REPORTABLE CONTRACTION STUCK ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11498912 ↗
• MalfunctionNov 16, 2020Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT A PATIENT UNDERWENT CARDIAC ABLATION PROCEDURE WITH A LASSO® NAV ECO VARIABLE CATHETER WHERE THROMBUS OCCURRED. CLOT FORMED ON SHAFT OF THE LASSO® NAV ECO VARIABLE CATHETER. CASE ABANDONED. NO PATIENT CONSEQUENCE. THE TRANSEPTAL PUNCTURE WAS PERFORMED. THE LASSO® NAV ECO VARIABLE CATHETER WAS PASSED INTO THE LEFT ATRIUM WHILST PREPARING FOR A SECOND PASS IT WAS NOTED BY THE TRANSOESOPHAGEAL ECHOCARDIOGRAPHY PHYSICIAN THAT THERE WAS A CLOT ON THE SHAFT OF THE LASSO® NAV ECO VARIABLE CATHETER. THE SYSTEM DID NOT PRESENT ANY ERROR MESSAGES. THE PATIENT WAS ANTICOAGULATED ((B)(4)). THE PATIENT WAS UNDER GENERAL ANESTHESIA FOR APPROX. 2 HOURS. IN THE PHYSICIAN¿S OPINION CANCELATION OF THE PROCEDURE COULD NOT CONTRIBUTE TO A DEATH OR A SERIOUS INJURY TO THE PATIENT. EXTENDED HOSPITALIZATION WAS NOT REQUIRED. PROCEDURE WAS ABORTED DUE TO THROMBUS FORMATION AND RISK OF EMBOLISM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10849329 ↗
• InjuryOct 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A REDO PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE ON WHICH A LASSO® NAV ECO VARIABLE CATHETER WAS USED, AND THROMBOSIS OCCURRED REQUIRING THROMBUS ASPIRATION. DURING THE PROCEDURE, 10000 UNITS OF HEPARIN WERE ADMINISTERED TO THE PATIENT. ACTIVATED CLOTTING TIME (ACT) WAS 236 SECONDS. THEN, A THROMBUS WAS NOTED POST LASSO INSERTION WITHIN THE LEFT ATRIUM (LA) ATTACHED TO ITS DISTAL SHAFT (APPROXIMATELY 1 CM BELOW CURVED LASSO SENSOR ARRAY) BETWEEN FIRST AND SECOND TRANSSEPTAL PUNCTURE. THROMBUS WAS CONFIRMED BY TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TOE). THROMBUS WAS NOTED PRIOR TO THE ABLATION CATHETER REACHING THE LA. ABLATION CATHETER WAS AT NO STAGE ADVANCED INTO THE LEFT ATRIUM. NIL ISSUES NOTED UPON CONNECTING OR FLUSHING THE ABLATION CATHETER. 5000 UNITS OF HEPARIN WERE ADMINISTERED. ACT POST DELIVERY WAS 322. 3000 U OF HEPARIN WERE THEN ADMINISTERED. ACT POST DELIVERY WAS 359. THE THROMBUS WAS ASPIRATED WITH A MEDIUM CURVE AGILIS SHEATH. REMINDER OF THE PROCEDURE WAS ABORTED. THE PATIENT DID NOT EXHIBIT NEUROLOGICAL SYMPTOMS SINCE THE PROCEDURE WAS COMPLETED. THE PHYSICIAN BELIEVED THE AMOUNT OF THROMBUS WAS EXCESSIVE

  Patient problems: Thrombosis

  MAUDE report 10759350 ↗
• InjurySep 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH LASSO® NAV ECO VARIABLE CATHETER AND CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND BLOOD TRANSFUSION. AFTER BROCKENBROUGH [TRANSSEPTAL], SHEATH WAS PLACED AND LASSO® NAV ECO VARIABLE CATHETER WAS PLACED IN THE LEFT ATRIAL APPENDAGE FOR LEFT ATRIAL IMAGING. WHEN THE LASSO® NAV ECO VARIABLE CATHETER WAS PULLED FROM THE LEFT ATRIAL APPENDAGE, THE RING PART STRETCHED OUT SO THAT IT COULD BE PULLED ON THE CARTO3 SCREEN, BUT IT WAS PULLED FROM THE ATRIAL APPENDAGE AND REMOVED ONCE FROM THE SHEATH. AFTER THAT, LEFT ATRIAL IMAGING WAS PERFORMED, AND AFTER A WHILE THE BLOOD PRESSURE BEGAN TO FALL, SO EFFUSION WAS CONFIRMED WHEN CONFIRMED BY ECHO. ADMINISTRATION OF NORADRENALINE AND DRAINAGE WERE PERFORMED, AND BLOOD PRESSURE WAS CALM [STABLE], BUT BLOOD CONTINUED TO SHRINK [FLOW], SO BLOOD TRANSFUSION WAS PERFORMED. AFTER CONTINUING FOR ABOUT AN HOUR, THE BLOOD FINALLY DISAPPEARED [HEMORRHAGE STOPPED] AND THE ECHO CONFIRMED THAT THERE WAS NO EFFUSION, AND THE PATIENT LEFT THE ICU. THERE WAS NO REPORT OF EXTENDED HOSPITALIZATION. THE PHYSICIAN IN CHARGE REPORTED THAT THEY FELT A LITTLE STUCK WHEN

  Patient problems: Cardiac Tamponade

  MAUDE report 10494620 ↗
• InjuryFeb 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR OLD MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A LASSO® NAV ECO VARIABLE CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. BEFORE THE TRANSSEPTAL PHASE, PERICARDIAL EFFUSION WAS NOTICED. CARDIAC TAMPONADE WAS CONFIRMED BY INTRACARDIAC ECHO (ICE) AND TRANSTHORACIC ECHO (TTE). PERICARDIOCENTESIS WAS PERFORMED AND 170CC OF FLUID WERE REMOVED FROM THE PERICARDIAL SPACE. THE PATIENT WAS REPORTED IN STABLE CONDITION AFTER PERICARDIAL DRAINAGE. EXTENDED HOSPITALIZATION WAS NOT REQUIRED AS A RESULT OF THE ADVERSE EVENT. PATIENT¿S OUTCOME IS FULLY RECOVERED WITH NO RESIDUAL EFFECTS. THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT THE INSERTION OF THE NON-BWI DIAGNOSTIC DECAPOLAR CATHETER MAY HAVE CONTRIBUTED TO THE EFFUSION. THE ONLY BIOSENSE WEBSTER INC. (BWI) PRODUCT INSIDE THE PATIENT¿S BODY AT THE TIME OF THE ADVERSE EVENT WAS A LASSO® NAV ECO VARIABLE CATHETER. THERE WAS NO EVIDENCE OF A STEAM POP. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A BAYLIS TRANSSEPTAL NEEDLE. A BWI ABLATION CATHETER WAS NEVER INTRODUCED INTO THE PATIENT¿S BODY. NO ABLATION WAS PERFORMED PRIOR TO THE

  Patient problems: Cardiac Tamponade

  MAUDE report 9688600 ↗
• InjuryDec 2, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A LASSO® NAV ECO VARIABLE CATHETER AND MEDICAL DEVICE ENTRAPMENT OCCURRED REQUIRING SURGICAL INTERVENTION. DURING THE PROCEDURE, WHILE MAPPING AROUND THE MITRAL ANNULUS, THE LASSO CATHETER SLIPPED THROUGH THE MITRAL VALVE AND GOT TANGLED IN THE PAPILLARY MUSCLES. IT WAS NOT POSSIBLE TO REMOVE THE CATHETER FROM THE PAPILLARY MUSCLES, SO THE PATIENT HAD TO GET THE CATHETER SURGICALLY REMOVED. IN THE PROCESS OF THE SURGERY, ONE STRING OF PAPILLARY MUSCLE WAS TORN AND HAD TO BE RESTRUCTURED WITHIN THE SAME SURGERY. THE ABLATION PROCEDURE WAS NOT COMPLETED. NO FRAGMENTS WERE GENERATED. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION TO TRACK HER HEALTH AND THE SURGERY OUTCOME. THE PATIENT¿S CONDITION HAS IMPROVED. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THE EVENT IS IT IS DUE TO AN UNFORTUNATE ACCIDENT THAT HAPPEN WHILE MAPPING AROUND THE MITRAL VALVE ANNULUS. IT IS NOT DUE TO A MALFUNCTION OF THE PRODUCT AND NOT DUE TO PATIENT CONDITION.

  Patient problems: No Code Available; Unspecified Heart Problem

  MAUDE report 9393297 ↗
• MalfunctionNov 25, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PAROXYSMAL ABLATION PROCEDURE WITH A LASSO® NAV ECO VARIABLE CATHETER AND FOREIGN MATERIAL WAS FOUND INSIDE THE PACKAGING. IT WAS DESCRIBED THAT THERE WAS HAIR FOUND INSIDE THE VACUUM PACKAGE. THERE WAS NO PATIENT CONSEQUENCE AND NO ADDITIONAL INFORMATION WAS PROVIDED. THE ISSUE OF FOREIGN MATERIAL WITHIN THE PACKAGING HAS BEEN ASSESSED AS AN MDR REPORTABLE MALFUNCTION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9373242 ↗
• InjuryOct 25, 2019Entrapment of Device; Sharp Edges; Entrapment of Device; Sharp Edges

  IT WAS REPORTED THAT A (B)(6) YEAR OLD MALE PATIENT UNDERWENT A CATHETER ABLATION OF PERSISTENT ATRIAL FIBRILLATION WITH A LASSO® NAV ECO VARIABLE CATHETER AND SUFFERED A MITRAL INSUFFICIENCY REQUIRING SURGICAL REPAIR. DURING THE PROCEDURE, THE LASSO® NAV ECO VARIABLE CATHETER GOT CAUGHT IN THE MITRAL VALVE WHICH REQUIRED SURGICAL REPAIR. WHEN THE CATHETER WAS WITHDRAWN, A PIECE OF THE VALVE WAS FOUND ON THE TIP OF THE LOOP. THE CUSTOMER CONFIRMED THAT THE CURVE OF THE CATHETER WAS NOT STUCK/JAMMED IN A FULL DEFLECTED POSITION. THERE WAS NO PROBLEM TO MANIPULATE THE KNOB/PISTON. THERE WAS DIFFICULTY IN REMOVING THE CATHETER. THERE WAS PHYSICAL DAMAGE OBSERVED AT THE DISTAL END OF THE CATHETER DESCRIBED AS A BROKEN LAST ELECTRODE. THE SHEATH USED WAS THE AGILIS SHEATH (ABBOTT). THE PROCEDURE WAS NOT COMPLETED. EXTENDED HOSPITALIZATION WAS REQUIRED. THE PATIENT HAD IMPROVED. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS THAT THE CAUSE IS NOT CLEAR. IT WAS NOT PATIENT CONDITION RELATED AS IT WAS A RELATIVELY YOUNG AND HEALTHY PATIENT. THE PROCEDURE WAS PERFORMED WITH THE SAME CONDITIONS AS USUAL. THE PHYSICIAN SPECULATED THAT PRODUCT MALFUNCTION MAY HAVE BEEN THE CAUSE

  Patient problems: Mitral Insufficiency; No Code Available

  MAUDE report 9241766 ↗
• MalfunctionSep 24, 2019Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A LASSO® NAV ECO VARIABLE CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB HAS IDENTIFIED ELECTRODE DAMAGE WITH SHARP EDGES. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT DURING THE PROCEDURE, THE PRODUCT SHOWED NO MALFUNCTION, HOWEVER, AFTER THE SUCCESSFUL PROCEDURE, THE PHYSICIAN CHECKED THE LASSO® NAV ECO VARIABLE CATHETER AND NOTICED A LIGHT KINKING BETWEEN THE ELECTRODE. THERE WERE NO PATIENT CONSEQUENCES. ON 7/5/2019, ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER INDICATING THE CUSTOMER DID NOT OBSERVE ANY SHARP RINGS, NO EXPOSED WIRES, NO DIFFICULTY INSERTING OR REMOVING THE CATHETER AND THE SHEATH USED WAS AN ABBOTT AGILIS 11.5 FRENCH. THE CUSTOMER¿S REPORTED ISSUE WAS ASSESSED AS NOT REPORTABLE SINCE THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. ON 8/20/2019, THE COMPLAINT PRODUCT WAS RETURNED TO BIOSENSE WEBSTER INC.¿S (BWI) PRODUCT ANALYSIS LAB (PAL) FOR EVALUATION. INITIAL VISUAL INSPECTION FOUND THE TIP OF LOOP IS SLIGHTLY BENT. THIS WAS NOT CONSIDERED TO BE MDR REPORTABLE. ON 9/10/2019, DURING A SECOND VI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9114213 ↗
• MalfunctionSep 6, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A LASSO® NAV ECO CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB IDENTIFIED TO BE STUCK IN A DEFLECTED POSITION. IT WAS INITIALLY REPORTED THAT DURING THE PROCEDURE THE LASSO® NAV ECO CATHETER COULD NOT CONTRACT TO VARIABLE SIZES. THERE WAS NO INDICATION OF HOW THE ISSUE WAS RESOLVED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE REPORTED CONTRACTION ISSUES ARE NOT MDR REPORTABLE SINCE THE LOOP CONTRACTION MECHANISM IS NOT WORKING PROPERLY, THE USER WILL NOT BE ABLE TO USE THE DEVICE AND WILL HAVE TO REPLACE IT. THE MOST LIKELY CONSEQUENCE IS AN INTRAPROCEDURAL DELAY. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH IS REMOTE. ON (B)(6) 2019, THE COMPLAINT PRODUCT WAS RETURNED TO BIOSENSE WEBSTER INC.¿S (BWI) PRODUCT ANALYSIS LAB (PAL) FOR EVALUATION. INITIAL VISUAL ANALYSIS OBSERVED THERE WAS NO VISUAL DAMAGE OR ANOMALIES. ON (B)(6) 2019, DURING A SECOND VISUAL ANALYSIS THE CATHETER WAS INSPECTED AND IT WAS FOUND IN GOOD CONDITIONS, NO VISUAL DAMAGES OBSERVED. HOWEVER, IT WAS NOTICED THAT CATHETER WAS STUCK IN A DEFLECTION POSITION. THIS FINDI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8972561 ↗
• MalfunctionApr 18, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A LASSO® NAV ECO VARIABLE CATHETER AND THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB NOTED THAT THE CATHETER TIP WAS STUCK IN A FULLY DEFLECTED POSITION. INITIALLY IT WAS REPORTED THAT THE END OF THE CATHETER WAS BROKEN. THEREFORE, THE CATHETER WAS EXCHANGED. THERE WAS NO CONSIDERABLE DELAY IN THE SURGERY. IT WAS NOT KNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. UPON REQUEST, ADDITIONAL INFORMATION WAS RECEIVED ON THE EVENT. NO WIRES EXPOSED. NO LIFTED OR SHARP RINGS. THERE WAS NO RESISTANCE OR DIFFICULTY DURING INSERTION OR REMOVAL OF THE CATHETER. THE CATHETER WAS NOT PRE-SHAPED. THE PREFACE SHEATH 8F REF 301803M WAS USED DURING THE PROCEDURE. PER THE RESPONSE RECEIVED THAT THERE WERE NO WIRES EXPOSED OR LIFTED OR SHARP RINGS, THIS EVENT WAS ASSESSED AS NOT REPORTABLE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, WAS REMOTE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND DISCOVERED ON MARCH 28, 2019 THAT THE CATHETER TIP WAS STUCK IN A FULLY DEFLECTED POSITION. THE H

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8529598 ↗
• InjuryMar 7, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE ON WHICH A LASSO® NAV ECO VARIABLE CATHETER WAS USED, AND A MEDICAL DEVICE ENTRAPMENT OCCURRED REQUIRING SURGICAL INTERVENTION. AFTER PVI WAS COMPLETED, THE LASSO® NAV ECO VARIABLE CATHETER WAS MOVED TO THE LEFT PULMONARY VEIN (LPV) FROM THE RIGHT PULMONARY VEIN (RPV) AND GOT CAUGHT IN THE CHORDA TENDINEAE. THE CATHETER WAS ATTEMPTED TO BE RELEASED, AND AS A RESULT THE CHORDA TENDINEAE WAS TORN OFF. THE PATIENT¿S PULSE RATE FELL FROM 90 TO 80, BUT THEN RETURNED TO 100 BPM. EXTENDED HOSPITALIZATION WAS REQUIRED TO OBSERVE PATIENT¿S PROGRESS. ON POST-PROCEDURE DAY 4, A MITRAL VALVULOPLASTY WAS PERFORMED SUCCESSFULLY. THERE¿S NO INFORMATION REGARDING THE PHYSICIAN¿S CAUSALITY OPINION. SINCE THIS ADVERSE EVENT REQUIRED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR REPORTABLE. THIS MEDICAL DEVICE ENTRAPMENT WAS ASSESSED AS REPORTABLE AS ANY INCIDENT WHERE THERE IS DIFFICULTY REMOVING A CATHETER FROM THE PATIENT¿S BODY WHETHER IT IS STUCK INSIDE OR BECOME TANGLED WITH ANOTHER CAT

  Patient problems: No Code Available

  MAUDE report 8397913 ↗
• MalfunctionAug 30, 2018Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A LASSO® NAV ECO VARIABLE CATHETER. ORIGINALLY IT WAS REPORTED THAT LEADS 1-6 WERE NOT WORKING AS THERE WAS NO SIGNAL. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THIS SIGNAL ISSUE ON LEADS 1-6 WAS ASSESSED AS NOT REPORTABLE AS THE RISK TO THE PATIENT WAS LOW. THE BIOSENSE WEBSTER FAILURE ANALYSIS LAB RECEIVED THE CATHETER FOR EVALUATION. IT WAS DISCOVERED ON (B)(6) 2018 THAT THERE WAS A CRACK BETWEEN THE SPINE COVER AND PEEK HOUSING. INTERNAL PARTS WERE EXPOSED. ON (B)(6) 2018 ADDITIONAL TESTING WAS PERFORMED ON THE DAMAGED AREA. THE SCANNING ELECTRON MICROSCOPE (SEM) RESULTS SHOWED EVIDENCE OF MECHANICAL DAMAGE, STRESS MARKS AND A HOLE ON THE SURFACE OF THE SPINE COVER. SINCE THE CATHETER INTEGRITY WAS NOT MAINTAINED AND INTERNAL COMPONENTS WERE EXPOSED TO THE PATIENT, THIS RETURNED CATHETER CONDITION WAS ASSESSED AS MDR REPORTABLE. THE AWARENESS DATE IS (B)(6), 2018.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7836186 ↗
• MalfunctionAug 8, 2018Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A LASSO® NAV ECO VARIABLE CATHETER, AND AT AN UNSPECIFIED POINT, THE LASSO CATHETER LOOP WAS STUCK. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THE ISSUE OF THE LASSO LOOP BEING STUCK HAS BEEN ASSESSED AS REPORTABLE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7764158 ↗
• InjuryJul 18, 2018Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH LASSO® NAV ECO VARIABLE CATHETER AND SUFFERED A MEDICAL DEVICE ENTRAPMENT REQUIRING A SURGICAL INTERVENTION. DURING THE PROCEDURE, THE LASSO® NAV ECO VARIABLE CATHETER WAS MANEUVERED FROM THE LEFT ATRIUM TO THE LEFT VENTRICLE VIA THE MITRAL VALVE. IN DOING SO, THE LASSO® NAV ECO VARIABLE CATHETER BECAME ENTRAPPED IN THE MITRAL CHORDAE TENDINAE. PHYSICIAN WAS UNABLE TO MANEUVER THE LASSO® NAV ECO VARIABLE CATHETER OUT OF THE LEFT VENTRICLE. A SURGICAL INTERVENTION WAS PERFORMED TO RELEASE THE MEDICAL DEVICE ENTRAPMENT. THERE IS NO INFORMATION ABOUT THE HOSPITALIZATION. IT WAS NOTED THAT THE ADVERSE EVENT WAS NOT THE RESULT OF ANY CATHETER MALFUNCTION. THERE WERE NO ISSUES, ERRORS, OR MALFUNCTIONS REPORTED ON ANY BIOSENSE WEBSTER, INC. PRODUCTS OR EQUIPMENT DURING THE PROCEDURE. THE PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION FOR THE CAUSE OF THIS ADVERSE EVENT. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. SINCE THIS ADVERSE EVENT REQUIRED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT

  Patient problems: No Code Available

  MAUDE report 7697313 ↗
• MalfunctionMar 29, 2018Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A LASSO®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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7384142 ↗
• InjuryJan 5, 2018Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A LASSO NAV CATHETER AND SUFFERED A CARDIAC VALVE RUPTURE REQUIRING SURGICAL INTERVENTION. DURING THE PROCEDURE, THE LASSO NAV CATHETER BECAME ENTRAPPED IN THE MITRAL VALVE. LASSO NAV CATHETER WAS SUCCESSFULLY REMOVED. PATIENT REQUIRED A MITRAL VALVE REPLACEMENT. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT, BUT NONE HAS BEEN MADE AVAILABLE.

  Patient problems: No Code Available; Rupture

  MAUDE report 7169925 ↗
• InjuryDec 19, 2017Entrapment of Device; Wrinkled; Material Integrity Problem; Appropriate Device Problem Term/Code Not Available; Entrapment of Device; Wrinkled; Material Integrity Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION WITH A LASSO NAVIGATIONAL VARIABLE ECO CATHETER AND SUFFERED A MEDICAL DEVICE ENTRAPMENT AND A CARDIAC VALVE RUPTURE REQUIRING SURGICAL INTERVENTION. WHILE MAPPING IN THE LEFT ATRIUM LASSO NAVIGATIONAL VARIABLE ECO CATHETER # 1 IN A PARTIALLY CURVED POSITION, THE CATHETER INADVERTENTLY TRAVELED FROM THE LEFT ATRIUM TO THE LEFT VENTRICLE AND BECAME ENTRAPPED. PHYSICIAN WAS UNABLE TO REMOVE LASSO NAVIGATIONAL VARIABLE ECO CATHETER # 1 WITH TURNING AND GENTLE RETRACTION. LASSO NAVIGATIONAL VARIABLE ECO CATHETER # 1 WAS FREED FROM THE ENTRAPMENT BY ADVANCING THE ST. JUDE MEDICAL AGILIS SHEATH OVER THE LOOP AND RETRACTING THE LASSO NAVIGATIONAL VARIABLE ECO CATHETER INTO THE SHEATH IN A CLOCKWISE DIRECTION. PHOTOGRAPHIC EVIDENCE REVEALED THE DISTAL PORTION OF THE LOOP TO BE INTACT. BIOLOGICAL MATERIAL WAS STUCK TO THE LOOP FROM ELECTRODE 6 TO THE PROXIMAL PORTION OF THE LOOP. THE SHAFT WAS WRINKLED BETWEEN LOOP ELECTRODES 6-7, 7-8, AND 8-9. INTERNAL COMPONENTS WERE EXPOSED AT THE PROXIMAL PORTION OF THE LOOP. IT WAS NOTED THAT THE DAMAGE TO THE LA

  Patient problems: No Code Available; Rupture

  MAUDE report 7129059 ↗

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.