Lassostar NAV D140401Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10846835020335), received between Feb 22, 2023 and Dec 5, 2024 — classified as 1 injury, 23 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (8 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2024Off-Label Use; Improper or Incorrect Procedure or Method; Device-Device Incompatibility; Off-Label Use; Improper or Incorrect Procedure or Method; Device-Device Incompatibility

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) CARDIAC PROCEDURE WHICH INCLUDED THE USE OF A LASSOSTAR NAV FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED THAT ONE OF THE ELECTRODES WAS LIFTED WITH INTERNAL COMPONENTS EXPOSED. INITIALLY, IT WAS REPORTED THAT WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE LASSOSTAR CATHETER THROUGH THE CRYO SHEATH, IT WAS UNABLE TO BE REMOVED. THE SHEATH AND CATHETER WERE THEN REMOVED FROM THE BODY TOGETHER. THE LASSONAV DISTAL TIP WAS LODGED IN THE SHEATH TOWARDS THE PROXIMAL END OF THE SHEATH AT THE HUB. AFTER THE CASE, THE SCRUB TECH WAS ABLE TO PULL AND REMOVE THE CATHETER FROM THE SHEATH. NO DAMAGE WAS NOTED ON THE CATHETER AND NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. THE EVENT WAS ASSESSED AS NON MDR REPORTABLE. THE BIOSENSE WEBSTER, INC. PAL RECEIVED THE DEVICE AND PER THE EVALUATION COMPLETION, THE SHAFT WAS OBSERVED BENT AND ONE OF THE ELECTRODES WAS LIFTED WITH INTERNAL COMPONENTS EXPOSED. THIS WAS ASSESSED AS MDR REPORTABLE WITH AN AWARENESS DATE OF 09-NOV-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20858453 ↗
• MalfunctionOct 31, 2024Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A LASSOSTAR NAV AND THE LASSO STAR PACKAGING WAS DAMAGED ON THE INSIDE OF THE BOX. THE STAFF HAD DIFFICULTY OPENING THE PACKAGE AND THE CATHETER WAS CONTAMINATED AS A RESULT. WHEN THE CATHETER WAS REPLACED, THE ISSUE WAS RESOLVED, AND THE PROCEDURE CONTINUED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20582254 ↗
• MalfunctionSep 20, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A LASSOSTAR NAV CIRCULAR MAPPING CATHETER AND POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB IDENTIFIED A DAMAGE ON SHAFT AND INTERNAL PARTS WERE EXPOSED. DURING THE CRYOABLATION, THE CATHETER WOULD NOT FIT THROUGH THE BALLOON AND BECAME BENT. THERE WAS RESISTANCE DURING INSERTION. THERE WERE NO WIRES EXPOSED OR LIFTED/SHARPENED RINGS. WHEN THE CATHETER WAS REPLACED, THE ISSUE WAS RESOLVED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20270036 ↗
• MalfunctionSep 11, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A LASSOSTAR NAV AND THE CATHETER TIP BROKE INTO PIECES. IT WAS REPORTED BY THE CALLER THAT THE LASSOSTAR NAV CATHETER THAT THE PHYSICIAN STATED THE CATHETER WAS HARD TO MANEUVER. UPON REMOVING THE CATHETER IT APPEARED TO BE KINKED TO THE POINT THAT IT WAS DIFFICULT TO REMOVE FROM THE BALLOON. AND RESULTED IN THE DISTAL END OF THE CATHETER BEING STRIPPED FROM THE BALLOON AND BREAKING INTO PIECES ONCE IT WAS PULLED OUT OF THE PATIENT. THE WAS NO PATIENT CONSEQUENCE. THE PHYSICIAN DECIDED TO NOT USE THE CRYO BALLOON AND THE LASSOSTAR CATHETER AND SWITCHED TO RF ABLATION. THE CASE CONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20197387 ↗
• MalfunctionAug 6, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A LASSOSTAR NAV CIRCULAR MAPPING CATHETER AND THE DEVICE BROKE ON THE DISTAL SIDE WHILE INSIDE THE PATIENT. THE CATHETER WAS REPLACED. IT TOOK 10 MINUTES TO RESOLVE THE ISSUE. THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19922772 ↗
• MalfunctionJun 12, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A LASSOSTAR NAV CIRCULAR MAPPING CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED THE SHAFT WAS BROKEN CLOSE TO THE TIP TRANSITION. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT THE LASSOSTAR NAV CIRCULAR MAPPING CATHETER KNICKED WHILE LEADING HIM INTO THE HELIOSTAR. THE ISSUE WAS RESOLVED BY CHANGING THE CATHETER. THE ISSUE WAS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. ON 16-MAY-2024, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THE SHAFT WAS BROKEN CLOSE TO THE TIP TRANSITION. THESE FINDING WAS REVIEWED AND ASSESSED THE ISSUE AS AN MDR REPORTABLE MALFUNCTION SINCE THE INTEGRITY OF THE DEVICE IS COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19525332 ↗
• MalfunctionFeb 26, 2024Device-Device Incompatibility; Material Protrusion/Extrusion; Device-Device Incompatibility; Material Protrusion/Extrusion

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PAROXYSMAL ABLATION PROCEDURE WITH A LASSOSTAR NAV CIRCULAR MAPPING CATHETER AND THE ELECTRODES AND THE MATERIAL COVERING THE TIP OF THE LASSO WERE DAMAGED AS THEY EXITED THE BALLOON LUMEN. IT WAS IMPOSSIBLE TO ASSEMBLE THE LASSOSTAR NAV UNTIL IT CAME OUT OF THE HELIOSTAR BALLOON DURING PREPARATION BEFORE INTRODUCING IT INTO THE PATIENT. THEY FOUND THAT THERE WAS RESISTANCE ON BOTH WHEN FITTING IT INTO THE BALLOON AND WHEN REMOVING IT. THE ELECTRODES AND THE MATERIAL COVERING THE TIP OF THE LASSO WERE DAMAGED AS THEY EXITED THE BALLOON LUMEN. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18784409 ↗
• MalfunctionFeb 15, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A LASSOSTAR NAV CIRCULAR MAPPING CATHETER AND DURING CASE SETUP ON THE BACK TABLE, WHILE INSERTING THE CATHETER THROUGH THE HEMOSTATIC VALVE, THERE WAS A "WEAK" POINT WHERE THE OUTER CASING OF THE CATHETER SHEARED OFF. THERE WERE SHARP EDGES AT THE SHEER POINT. THE INTERNAL WIRES WERE EXPOSED. THE AFFECTED AREA WAS ABOUT 6 INCHES BEFORE THE LOOP--THERE WAS A TRANSITION OF METAL MATERIAL IN THIS AREA. SINCE THE CATHETER HAS A PRE SHAPED LASSO STYLE LOOP, A STRAIGHTENING INTRODUCER WAS USED TO STRAIGHTEN THE LOOP BEFORE TRYING INSERTION. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18716778 ↗
• MalfunctionJan 3, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE WITH A LASSOSTAR NAV CIRCULAR MAPPING CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED THE SHAFT AND TIP WITH A WRINKLED TEXTURE, AND ELECTRODE LIFTED WITH EDGES. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT THE LASSOSTAR NAV CIRCULAR MAPPING CATHETER HAS BECOME STUCK INSIDE THE LUMEN OF THE HELIOSTAR BALLOON CATHETER. THERE WAS NO PATIENT CONSEQUENCE AND NO OTHER DETAILS ABOUT THE EVENT WERE PROVIDED. AS SUCH, THE EVENT WAS ASSESSED AS A NOT REPORTABLE MALFUNCTION SINCE THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. ON 12-DEC-2023, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THE SHAFT AND TIP WITH A WRINKLED TEXTURE, AND ELECTRODE LIFTED WITH EDGES. THESE FINDINGS WERE REVIEWED AND ASSESSED THE ISSUE OF DAMAGE ON THE ELECTRODE TO BE AN MDR REPORTABLE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18441464 ↗
• MalfunctionJan 1, 2024Material Separation; Communication or Transmission Problem; Device-Device Incompatibility; Material Separation; Communication or Transmission Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A LASSOSTARNAV,10P,15MM DIA LOOP AND THE CATHETER FELL APART. IT WAS REPORTED THAT THE LASSOSTARNAV CATHETER FELL APART AND IS CURRENTLY STUCK INSIDE THE CRYO BALLOON. THE CATHETER WAS REPLACED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18423292 ↗
• MalfunctionDec 14, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A LASSOSTAR NAV CIRCULAR MAPPING CATHETER AND THE LASSO WAS CAUGHT AND COULD NOT BE RELEASED FROM THE VALVE WITH SEVERAL MANEUVER ATTEMPTS. DURING AN AFIB PROCEDURE, AFTER INSERTING THE LASSO, THEY BEGAN MAPPING THE VEINS. AFTER WHICH THE LASSO APPROACHED TO THE MITRAL VALVE. THE MEDICAL PROFESSIONAL WANTED TO RETURN THE LASSO BACK INTO THE HELIOS BALLOON AND FELT THAT THE LASSO WAS CAUGHT AND COULD NOT BE RELEASED FROM THE VALVE. SEVERAL MANEUVER ATTEMPTS WERE MADE TO RELEASE BUT WITHOUT SUCCESS. IT WAS DECIDED TO INSERT A TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) IN ORDER TO SEE WHAT IS HAPPENING INSIDE THE LEFT ATRIUM AND WITH THE HELP OF THE TEE AND ANOTHER MANEUVER WITH THE HELIOS BALLOON AND THE SHEATH, THE LASSO CATHETER WAS RELEASED FROM THE LEAFLET OF THE MITRAL VALVE AND THE OPERATION ENDED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE AND NO DAMAGE TO THE CATHETER. THE CATHETER DID NOT GO INTO THE VENTRICLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18325903 ↗
• MalfunctionNov 1, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A LASSOSTAR NAV CIRCULAR MAPPING CATHETER AND A BROKEN ISSUE OCCURRED. THE LASSOSTAR NAV CIRCULAR MAPPING CATHETER WOULD NOT GO THROUGH WHEN THE ADVANCEMENT HELIOSTAR KNOB WAS IN THE ¿ADVANCE POSITION¿. THE LASSOSTAR NAV CIRCULAR MAPPING CATHETER GOT BROKEN IN THE PROCESS. THIRD HELIOSTAR AND SECOND LASSOSTAR WERE OPENED. THERE WERE NO PATIENT CONSEQUENCE 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 18051756 ↗
• MalfunctionOct 19, 2023Manufacturing, Packaging or Shipping Problem; Material Twisted/Bent; Manufacturing, Packaging or Shipping Problem; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH LASSOSTAR NAV CIRCULAR MAPPING CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED SOME RINGS DAMAGED (I.E. DENTED AND SHARP EDGES), THE TIP SECTION WAS OBSERVED TO BE DAMAGED, AND INTERNAL COMPONENTS WERE EXPOSED. INITIALLY IT WAS REPORTED THAT THE LASSOSTAR NAV CIRCULAR MAPPING CATHETER WIRE WAS KINKED DIRECTLY OUT OF THE PACKAGE. THE CATHETER WAS REPLACED AND THE NEXT ONE WAS ALSO KINKED. WHEN THE CATHETER WAS REPLACED AGAIN, THE ISSUE RESOLVED. ALL CATHETERS WERE FROM THE SAME LOT NUMBER. NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. NO PHYSICAL DAMAGE TO THE OUTER BOX OR PACKAGING. NO PICTURES AVAILABLE. WAS NOT ABLE TO TAKE PICTURES DURING THE PROCEDURE. THE DEVICE WAS SECURED PROPERLY IN THE TRAY. NO DAMAGE TO THE DEVICE DUE TO ANY PART OF THE PACKAGING BEING DAMAGED. EVERYTHING WAS DISCARDED EXCEPT THE CATHETERS. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 22-SEP-2023, A BENT WAS OBSERVED ON THE SHAFT. ADDITIONALLY, SOME RINGS WERE OBSERVED TO BE DAMAGED (I.E. DENTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17964804 ↗
• MalfunctionOct 12, 2023Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A LASSOSTAR NAV CIRCULAR MAPPING CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED THE SHAFT WAS BROKEN IN THE MIDDLE SECTION WITH ELECTRICAL WIRES EXPOSED. IT WAS INITIALLY REPORTED THERE THIS LASSOSTAR NAV CIRCULAR MAPPING CATHETER WAS STUCK WITHIN A HELIOSTAR CATHETER BUT THERE WAS NO REPORTED PROBLEMS WITH THE LASSOSTAR NAV CIRCULAR MAPPING CATHETER. THE CUSTOMER REPORTED EVENT WAS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH IS REMOTE. ON (B)(6)-2023, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND FOUND THE SHAFT WAS BROKEN IN THE MIDDLE SECTION WITH ELECTRICAL WIRES EXPOSED. THESE FINDINGS WERE REVIEWED AND ASSESSED THESE TO BE AN MDR REPORTABLE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17928253 ↗
• MalfunctionAug 30, 2023Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A LASSOSTAR NAV CIRCULAR MAPPING CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED THE SHAFT BROKEN LEAVING WIRES EXPOSED. INITIALLY A CATHETER SENSOR ERROR WAS REPORTED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE CATHETER SENSOR ERROR ISSUE WAS ASSESSED AS NON MDR REPORTABLE. THE INCIDENCE OF MAGNETIC SENSOR ERROR IS EASY DETECTABLE BY THE USER. THE CATHETER WAS INOPERABLE, SINCE IT CANNOT BE VISUALIZED ON THE CARTO SYSTEM. THE USER WILL HAVE TO REPLACE THE CATHETER. THE MOST LIKELY CONSEQUENCE WAS AN INTRAPROCEDURAL DELAY. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH WAS REMOTE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON (B)(6) 2023, THE SHAFT WAS BROKEN LEAVING WIRES EXPOSED. THE SHAFT WAS BROKEN LEAVING WIRES EXPOSED WAS ASSESSED AS MDR REPORTABLE. THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING WAS 03-AUG-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17651913 ↗
• MalfunctionJul 26, 2023Material Protrusion/Extrusion; Material Twisted/Bent; Material Protrusion/Extrusion; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED ABLATION PROCEDURE WITH A LASSOSTAR¿ NAV CIRCULAR MAPPING CATHETER AND DUE TO RESISTANCE 4 LASSOSTARS WERE EITHER PHYSICALLY DAMAGED OR PROVIDED AN ERROR 116 FORCE SENSOR ERROR. IT WAS CONFIRMED THAT TWO OF THE LASSOSTARS HAD A KINKED SHAFT AND BROKEN SENSOR. NO PATIENT CONSEQUENCES WERE REPORTED. NO FURTHER PROCEDURAL DETAILS WERE PROVIDED. THE KINKED SHAFT IS NOT MDR-REPORTABLE. THE (PHYSICALLY) BROKEN SENSOR IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17398130 ↗
• MalfunctionJun 28, 2023Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A LASSOSTAR NAV CIRCULAR MAPPING CATHETER AND AN INTERNAL COMPONENTS ISSUE OCCURRED. AT THE BEGINNING OF THE PROCEDURE, WHEN INTRODUCING THE LASSOSTAR NAV CIRCULAR MAPPING CATHETER INTO THE HS CATHETER, IT FELT SOME RESISTANCE WHICH WAS RELIEVED BY MOVING THE INFLATION KNOB IN THE HANDLE. THEN IN THE MIDDLE OF THE PROCEDURE, AFTER 2 VEINS WERE ABLATED, THE GUIDESTAR SHEATH (DISTRIBUTED DEVICE) STEERING MECHANISM BROKE AND IT WAS NOT POSSIBLE TO CURVE IT ANYMORE. THEY REPLACED THE GUIDESTAR SHEATH FOR A NEW ONE. LASTLY, WHEN REMOVING CATHETERS FROM THE PATIENT, THE LASSOSTAR NAV CIRCULAR MAPPING CATHETER BROKE AND CAME OUT WITHOUT THE "LASSO" WITH THE 10 ELECTRODES. FRAGMENTS WERE GENERATED AND WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THE FRAGMENTS ARE INSIDE THE HELIOSTAR CATHETER. IT WAS ONLY CONFIRMED WITH XRAY. THE PROCEDURE WAS DELAYED 10 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS UNKNOWN IF THERE WAS ANY MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED. THERE WAS NO PATIENT CONSEQUENCE. IT WAS PART OF A CLINICAL STUDY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17221604 ↗
• MalfunctionMay 19, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A LASSOSTAR NAV CIRCULAR MAPPING CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED THE SHAFT BROKEN. PVI IT WAS IMPOSSIBLE TO INTRODUCE THE LASSOSTAR NAV CIRCULAR MAPPING CATHETER THROUGH THE INNER LUMEN PAST A CERTAIN POINT. THE LASSOSTAR NAV CIRCULAR MAPPING CATHETER WAS SNAPPED IN THE PROCESS OF ATTEMPTING TO INTRODUCE IT. USED A NEW LASSOSTAR. FIVE MINUTE DELAY. NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. A Y-ADAPTOR WAS CONNECTED TO THE HELIOSTAR CATHETER. THERE WAS NO OCCLUSION WHEN IRRIGATING THE HELIOSTAR CATHETER. THE SHEATH / HELIOSTAR WAS NOT IN A DEFLECTED STATE. IT WAS DURING THE PREPARATION OF THE BALLOON. NO DAMAGED RINGS. THE HELIOSTAR CATHETER DID NOT NARROW, DID NOT PARTIALLY BLOCK NOR COMPLETELY BLOCKED. THE DAMAGE DID NOT RESULT IN WIRES BEING EXPOSED. THE DAMAGE DID NOT RESULT IN ANY LIFTED OR SHARP RINGS. THE CATHETER WAS NOT PRE-SHAPED. CLARIFICATION TO THE EVENT WHICH WAS ORIGINALLY REPORTED AS ¿SNAPPED¿ WAS RECEIVED. THE REPORTER STATES ¿IT WAS BENT¿. THE EVENT WAS ASSESSED AS NON MDR REPORTABLE FOR A BENT TIP ISSUE. THE POTENTIAL THAT IT COULD CAUS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16968144 ↗
• MalfunctionMay 17, 2023Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A LASSOSTAR NAV CIRCULAR MAPPING CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A KNOTTED CATHETER ISSUE AND A BROKEN SHAFT (MID SHAFT) ISSUE. INITIALLY IT WAS REPORTED PVI CATHETER SENSOR ERROR. THE DEVICE WAS CHANGED. THERE WAS A 15 MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE. THE EVENT WAS ASSESSED AS NON MDR REPORTABLE FOR A MAGNETIC SENSOR ERROR. THE INCIDENCE OF MAGNETIC SENSOR ERROR IS EASY DETECTABLE BY THE USER. THE CATHETER IS INOPERABLE, SINCE IT CANNOT BE VISUALIZED ON THE CARTO SYSTEM. THE USER WILL HAVE TO REPLACE THE CATHETER. THE MOST LIKELY CONSEQUENCE WAS AN INTRAPROCEDURAL DELAY. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH WAS REMOTE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON (B)(6) 2023, THE DEVICE'S SHAFT WAS KNOTTED AND BROKEN WITH INTERNAL PARTS EXPOSED. THE RETURNED CONDITION WAS ASSESSED AS MDR REPORTABLE FOR A KNOTTED CATHETER ISSUE AND A BROKEN SHAFT (MID SHAFT) ISSUE. THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING WAS (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16949967 ↗
• MalfunctionApr 27, 2023Device-Device Incompatibility; Material Protrusion/Extrusion; Device-Device Incompatibility; Material Protrusion/Extrusion

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ¿ PAROXYSMAL ABLATION PROCEDURE WITH A LASSOSTAR NAV CIRCULAR MAPPING CATHETER AND INTERNAL COMPONENTS WERE EXPOSED. IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO ADVANCE THE LASSOSTAR NAV CIRCULAR MAPPING CATHETER THROUGH THE HELIOSTAR (HS) CATHETER IF THE INFLATION KNOB WAS IN THE ¿DEFLATED¿ MODE SO IT WAS PRESSED TO ¿INFLATE¿ TO ALLOW THE LASSOSTAR NAV CIRCULAR MAPPING CATHETER PASS AND THEN PULLED AGAIN TO ¿DEFLATE¿ TO BE ABLE TO ENTER INTO THE GUIDESTAR. AFTER THE 3RD VEIN ISOLATION THE LASSOSTAR NAV CIRCULAR MAPPING CATHETER FELT WITH BAD MANEUVERABILITY AND WAS REMOVED TO INSPECT AND NOTICED THE PLASTIC ON THE LASSO WAS WRINKLED AND THAT A LITTLE METAL NEEDLE PART OF A CABLE WAS EXPOSED. THE CATHETER WAS REPLACED. THERE WAS NO PATIENT CONSEQUENCE. THE CUSTOMER¿S REPORTED ISSUE OF RESISTANCE WITH THE SHEATH IS NOT CONSIDERED TO BE MDR REPORTABLE SINCE AN INCREASED POTENTIAL FOR PATIENT INJURY IS REMOTE. THIS ISSUE IS REPORTABLE FOR THE INTERNAL COMPONENTS EXPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16827458 ↗
• MalfunctionApr 21, 2023Device-Device Incompatibility; Material Protrusion/Extrusion; Material Twisted/Bent; Device-Device Incompatibility; Material Protrusion/Extrusion; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED ABLATION PROCEDURE INVOLVING A LASSOSTAR¿ NAV CIRCULAR MAPPING CATHETER AND THE DEVICE WAS DIFFICULT TO MANEUVER. WHEN THE LASSOSTAR WAS REMOVED, THERE WAS A VISIBLE KINK ON THE DEVICE. NO FRAGMENTS WERE GENERATED. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY DELAYS. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL DEVICE DETAILS: THE DAMAGE RESULTED IN AN EXPOSED WIRE. THERE WERE NO SHARP OR LIFTED RINGS; HOWEVER, THE PLASTIC BETWEEN THE ELECTRODES WAS SHRUGGED. RESISTANCE WAS ALSO NOTED: IT WAS NOT POSSIBLE TO PASS THROUGH THE HELIOSTAR BALLOON WHEN THE INFLATION KNOB WAS ON THE ¿DEFLATED MODE¿. THEN THE INFLATION KNOB RETRACTED TO ¿INFLATE MODE¿ TO ALLOW THE CATHETER TO PASS AND THEN EXTENDED AGAIN TO ¿DEFLATE MODE¿ AND FUNCTIONAL UNTIL LATER IN THE PROCEDURE WHERE ABUNDANT RESISTANCE TO MOVE OCCURRED. AT THIS POINT, THE DEVICE WAS WITHDRAWN FROM THE PATIENT. BENT SHAFT IS NOT MDR-REPORTABLE. RESISTANCE WITH LUMEN IS NOT MDR-REPORTABLE. INTERNAL COMPONENTS EXPOSED IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16782695 ↗
• MalfunctionMar 22, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A LASSOSTAR NAV AND A CATHETER SHAFT DETACHED/BROKEN INSIDE THE PATIENT ISSUE OCCURRED. THE LASSOSTAR NAV CATHETER WAS ALREADY INSERTED INTO THE BALLOON AND HAD TO BE PULLED OUT TO INSERT IT INTO THE NEW BALLOON. UNFORTUNATELY, IT BROKE DURING THIS PROCESS AND WAS EXCHANGED FOR A NEW CATHETER OF THE SAME TYPE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING ANOTHER TECHNOLOGY (PFA) FROM ANOTHER COMPANY WITHOUT ANY CONSEQUENCES FOR THE PATIENT. TOTAL TROUBLESHOOTING DELAY WAS 25 MINUTES. ADDITIONAL INFORMATION WAS RECEIVED. THE DAMAGE DID NOT RESULT IN WIRES BEING EXPOSED. THE DAMAGE DID NOT RESULT IN ANY LIFTED OR SHARP RINGS. WHEN THE NEW LASSOSTARNAV CATHETER WAS INSERTED INTO THE NEW HELIOSTAR BALLOON, IT WAS NOT POSSIBLE TO PUSH IT FORWARD, BECAUSE THERE WAS RESISTANCE INSIDE THE HANDLE OF THE BALLOON. THERE ARE NO PICTURES AVAILABLE. THE ISSUE WAS APPROXIMATELY 30CM FROM TIP. THE CATHETER WAS NOT PRE-SHAPED. THE SHAFT GOT BROKEN. THE EVENT WAS ASSESSED AS MDR REPORTABLE FOR THE CATHETER SHAFT DETACHED/BROKEN INSIDE THE PATIENT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16591212 ↗
• MalfunctionMar 1, 2023Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A LASSOSTARNAV,10P,15MM DIA LOOP AND A 28 MM BALLOON ABLATION CATHETER . IT WAS REPORTED THAT DURING AN AFIB PROCEDURE WHEN TRYING TO INTRODUCE THE LASSOSTAR CATHETER INSIDE THE LUMEN OF THE HELIOSTAR THE LASSOSTAR WAS STUCK IN THE LUMEN. SEVERAL ATTEMPTS WERE TRIED TO ADVANCE IT IN THE LUMEN WHICH EVENTUALLY MADE ITS' MAGNETIC SENSOR MALFUNCTIONING. BOTH CATHETERS WERE REPLACED WITH NEW ONES AND THE PROCEDURE CONTINUED AND ENDED SUCCESSFULLY. NO PATIENT CONSEQUENCES. SIZE OF SHEATH USED WAS 14F. THE INCIDENT HAPPENED BEFORE INTRODUCING IT TO THE SHEATH. THE IRRIGATION WAS REDUCED TO 5ML/MIN. THE CATHETER WAS NOT IN THE DEFLECTED STATE. THE BALLOON WAS EXTENDED (COLLAPSED). THE PHYSICIAN WAITED 30 SECONDS UNTIL RETRACTING THE BALLOON INTO THE SHEATH. IT WAS NOT POSSIBLE TO PASS A WIRE OR LASSOSTAR THROUGH THE BALLOON. INTRODUCER STUCK WITHIN SHEATH IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16464684 ↗
• InjuryFeb 22, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A LASSOSTAR, 10P, DIA 15MM LOOP SIZE AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. IT WAS REPORTED THAT PERICARDIAL FLUID WAS OBSERVED AT THE END OF THE PROCEDURE. THE EVENT OCCURRED PER-OP. INTERVENTION DONE WAS ADJUVANT DRUG THERAPY BY ANESTHESIA AND ¿PRESSURE MONITORING DU¿. PERICARDIOCENTESIS WAS PERFORMED AND PATIENT WAS STABLE AND UNDER CONTROL. THE PROCEDURE WAS PROLONGED FOR 20 MINUTES BECAUSE OF THE DIFFICULTIES ENCOUNTERED WITH THE DEVICE.

  Patient problems: Cardiac Tamponade

  MAUDE report 16419103 ↗