NaviStar NS7TCFL174HSRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10846835000610), received between Aug 3, 2016 and Jun 17, 2025 — classified as 1 death, 17 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (11 reports).

1 other recall cover devices cleared under the same FDA submission (P990025); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryJun 17, 2025Device Contamination with Body Fluid; Patient Device Interaction Problem; Device Contamination with Body Fluid; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH A NAVISTAR CATHETER, THE PATIENT EXPERIENCED A BRIEF AV BLOCK, IMPAIRED AV CONDUCTION, 2:1 CONDUCTION TREATED WITH TEMPORARY RIGHT VENTRICLE (RV) CATHETER. DURING THE AVNRT CARTO PROCEDURE, A BRIEF AV BLOCK WAS OBSERVED, FOLLOWED BY IMPAIRED AV CONDUCTION. THIS OCCURRED AFTER THE LAST ABLATION POINT WITHOUT ANY PRIOR SIGNS. ABLATION WAS SUFFICIENTLY FAR AWAY FROM THE HIS. INITIAL ABLATION POINTS WERE PERFORMED AT 35 WATTS, THEN INCREASED TO 40 W. TEMPERATURE MODE. SMART ABLATE GENERATOR. THE PATIENT LEFT THE TABLE WITH A 2:1 CONDUCTION/AV BLOCK NOT COMPLETE, AND A TEMPORARY RV CATHETER. HOWEVER, HE IMPROVED DURING THE WAITING PERIOD. CHARGING AT THE CATHETER TIP WAS CONFIRMED. THE PHYSICIAN'S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS MYOCARDIAL EDEMA DUE TO RF ABLATION OF THE SLOW PATHWAY REGION, AND THE OUTCOME OF THE ADVERSE EVENT WAS FULLY RECOVERED.

  Patient problems: Heart Block

  MAUDE report 22253838 ↗
• MalfunctionMay 8, 2025Coagulation in Device or Device Ingredient; Off-Label Use; Device Contamination with Body Fluid; Device Sensing Problem; Coagulation in Device or Device Ingredient; Off-Label Use; Device Contamination with Body Fluid; Device Sensing Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A NAVISTAR CATHETER AND THE PHYSICIAN CONSIDERED THAT THE CHAR WAS EXCESSIVE. THE NAVISTAR (4MM) WAS USED FOR AN ATRIAL TACHYCARDIA (AT) ABLATION RIGHT SIDED. AFTER SEVERAL BURNS, PHYSICIAN COMPLAINED THAT POWER / TEMPERATURE RATIO WAS BAD AND TOOK THE CATHETER OUT. VISIBLE CHARRING ON TIP AFTER 60W/60°C ABLATION SETTING. A THERMOCOOL WAS USED TO TREAT THE PATIENT FURTHER. PROCEDURE DELAYED BY 4 MINUTES. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 15-APR-2025. THE PHYSICIAN CONSIDERED THAT THE CHAR WAS EXCESSIVE. THE PHYSICIAN DID NOT REALLY CONSIDER THAT THE AMOUNT OF CHAR CAUSED A POTENTIAL RISK TO THIS PATIENT SINCE IT WAS A RIGHT-SIDED ABLATION. THE SYSTEM DID NOT PRESENT ANY ERROR MESSAGE; JUST BAD POWER OUTPUT (HIGH TEMPERATURE AND LOW POWER) AFTER SEVERAL PROBABLY BECAUSE OF ALREADY CHARRED TIP. USED NON-IRRIGATED CATHETER. THE GENERATOR THRESHOLD WAS 60W/60'C. THE NOTED TEMPERATURE, IMPEDANCE AND POWER WERE NORMAL IN THE BEGINNING. WORSE AFTER SEVERAL BURNS (HIGH POWER 60'C AND BAD POWER ~ 15W). STANDARD HEPARIN BOLUS BEFORE ABLATION, NO ACT BECAUSE RIGHT SIDED A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21991036 ↗
• InjuryMar 8, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION WITH A NAVISTAR AND THE PATIENT EXPERIENCED A COMPLETE AV BLOCK THAT REQUIRED PROLONGED HOSPITALIZATION. DURING THE PROCEDURE, AN AV BLOCK OCCURRED. ADDITIONAL INFORMATION WAS RECEIVED. THE ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. PATIENT'S CONDITION WORSENED AND COMPLETE ATRIOVENTRICULAR BLOCK OCCURRED. PATIENT REQUIRED EXTENDED HOSPITALIZATION TO MONITOR THE PATIENT'S CONDITION. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THE ADVERSE EVENT WAS PROCEDURE RELATED. NO PUMP USED.

  Patient problems: Heart Block

  MAUDE report 21555765 ↗
• InjuryFeb 24, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION AND THE PATIENT EXPERIENCED CHEST PAIN / ST ELEVATION THAT REQUIRED PROLONGED HOSPITALIZATION. DURING AN ABLATION PROCEDURE FOR THE TREATMENT OF SUPRAVENTRICULAR TACHYCARDIA TYPE AVNRT, THE ELECTROPHYSIOLOGIST PERFORMED ABLATIONS IN VARIOUS PLACES IN THE RIGHT ATRIUM USING A 4MM NAVISTAR CATHETER THAT DID NOT RESULT IN CESSATION OF THE ARRHYTHMIA. FOR THIS REASON, THE ELECTROPHYSIOLOGIST DECIDED TO MOVE FORWARD WITH WORKING WITH THE SAME CATHETER (4MM NAVISTAR), TO ABLATE IN THE LEFT ATRIUM, IN ORDER TO TRY TO STOP THE ARRHYTHMIA AND BEGAN PERFORMING ABLATIONS IN THE LEFT ATRIUM AS WELL. SINCE THE ARRHYTHMIA WAS NOT STOPPED, THE ELECTROPHYSIOLOGIST DECIDED TO CONTINUE ABLATING IN THE LEFT ATRIUM WITH A THERMOCOOL SMARTTOUCH SF CATHETER. BETWEEN THE 24TH AND 25TH ABLATION SESSION (THIS NUMBER INCLUDES THE TOTAL BURNS IN THE RIGHT AND LEFT ATRIUM TOGETHER WITH BOTH TYPES OF CATHETERS), ST-SEGMENT ELEVATIONS WERE OBSERVED ON THE PATIENT'S ELECTROCARDIOGRAM (ECG) AND THE PATIENT FELT CHEST PAIN. IT SHOULD BE NOTED THAT ST ELEVATIONS INDICATE A LACK OF BLOOD SUPPLY TO THE HEART MUSC

  Patient problems: Chest Pain; Ischemic Heart Disease

  MAUDE report 21454714 ↗
• MalfunctionOct 16, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER AND POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB IDENTIFIED THAT THE CONNECTOR WAS DETACHED FROM THE HANDLE. DURING THE PROCEDURE ITSELF, THE MEDICAL TEAM DISCOVERED THAT THE CATHETER TIP WAS DEFECTIVE. THE TIP OF THE CABLE ENTRY ON THE CATHETER WOULD COME OFF. THE ISSUE WAS NOTED BEFORE USAGE, SO THIS DEVICE NEVER TOUCHED THE PATIENT. THE CATHETER WAS CHANGED AND THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20464151 ↗
• MalfunctionSep 6, 2024Failure to Sense; Communication or Transmission Problem; Failure to Sense; Communication or Transmission Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A NAVISTAR AND A TOTAL ECG SIGNAL LOSS OCCURRED. IT WAS INITIALLY REPORTED THAT THERE WAS AN ERROR 105. NO CATHETER WAS SHOWN, NO SIGNAL WAS ON THE ECG SYSTEM. THE CABLE WAS CHANGED AND THE ISSUE PERSISTED. THE CATHETER WAS CHANGED AND THE PROBLEM WAS GONE. THERE WAS NO PATIENT CONSEQUENCE. THE EVENT WAS INITIALLY CONSIDERED NOT REPORTABLE SINCE THE RISK TO THE PATIENT IS LOW. ON 26-AUG-2024, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THERE WERE NO SIGNALS AT ALL SHOWING ON THE CARTO 3 OR BARD SYSTEMS WHILE THE CATHETER WAS IN THE PATIENTS BODY AND NO OTHER MONITOR AVAILABLE TO MONITOR THE PATIENTS HEART RHYTHM. AS SUCH, BASED ON THE NEW INFORMATION, THE EVENT WAS REASSESSED AS AN MDR REPORTABLE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20158011 ↗
• InjuryJul 3, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AVNRT (ATRIOVENTRICULAR NODAL RE-ENTRANT TACHYCARDIA) ABLATION WHICH INCLUDES THE USE OF A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. IT WAS REPORTED THAT SYMPTOMS "ARISED" POST OP. PERICARDIAL TAMPONADE NOTED. PERICARDIOCENTESIS WAS PERFORMED. THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT IS THE PROCEDURE. NO TRANSSEPTAL PUNCTURE WAS PERFORMED. NO EVIDENCE OF STEAM POP. NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. THE PATIENT FULLY RECOVERED BUT REQUIRED EXTENDED HOSPITALIZATION (ONE MORE NIGHT FOR FOLLOW UP). PATIENT DID NOT REQUIRE CARDIAC SURGERY.

  Patient problems: Cardiac Tamponade

  MAUDE report 19671048 ↗
• MalfunctionDec 28, 2023Break; Manufacturing, Packaging or Shipping Problem; Packaging Problem; Break; Manufacturing, Packaging or Shipping Problem; Packaging Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER (AFL) ABLATION PROCEDURE WITH A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER. PACKAGING OF THE DEVICE WAS SLIGHTLY DAMAGED BEFORE THE DEVICE WAS TAKEN OUT OF THE PACKAGING (NO EXACT INFORMATION AVAILABLE ABOUT WHERE AND HOW THE PACKAGING WAS DAMAGED). THE MEDICAL TEAM THEN TOOK THE DEVICE OUT OF THE PACKAGING IN ORDER TO CHECK THE DEVICE FOR POSSIBLE DEFECTS, THEN DURING MANIPULATION OF THE DEVICE, THE CUSTOMER NOTICED THAT THE CATHETER TIP IS OUTSIDE THE SOCKET AND THE CABLING AT THE INSIDE BECAME VISIBLE. IT CAN BE ASSUMED THAT THE DESCRIBED DEFECT IS RELATED TO THE DAMAGED CATHETER PACKAGING AND THE FOLLOWING MANIPULATION OF THE DEVICE. IT WAS THEN REPLACED WITH ANOTHER CATHETER. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18414273 ↗
• InjuryDec 20, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL RE-ENTRANT TACHYCARDIA (AVNRT) CARDIAC ABLATION PROCEDURE WITH A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER AND THE PATIENT EXPERIENCED ATRIOVENTRICULAR BLOCK. PATIENT STAYED IN INTENSIVE CARDIOLOGY HEALTHCARE FOR TWO DAYS, AND SINCE HE DID NOT RECOVER, HE WAS IMPLANTED WITH A PACEMAKER. THE PHYSICIAN'S OPINION ON THE CAUSE WAS THAT IT WAS PROCEDURE RELATED (SHOT TOO CLOSE FROM HIS), AS WELL AS PATIENT CONDITION RELATED (WEAK CONDUCTION PATHWAY).

  Patient problems: Heart Block

  MAUDE report 18370042 ↗
• MalfunctionJul 20, 2023Contamination /Decontamination Problem; Manufacturing, Packaging or Shipping Problem; Contamination /Decontamination Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER AND A WHITE DUSTY POWDER WAS FOUND ON THE HANDLE OF THE CATHETER. WHEN THE STERILE BAG WAS OPENED, A WHITE DUSTY POWDER WAS FOUND ON THE HANDLE OF THE CATHETER. THE ISSUE WAS RESOLVED BY REPLACING THE NAVISTAR CATHETER TO ANOTHER NEW ONE. THE DEVICE WAS NOT USED ON THE PATIENT. THE FOREIGN MATERIAL WAS LOOSE WITH MOVEMENT. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17361216 ↗
• InjuryApr 5, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AVRT (ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA) ABLATION PROCEDURE WITH A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER AND THE PATIENT SUFFERED A SOFT TISSUE INJURY REQUIRING SURGICAL INTERVENTION FOR PACEMAKER. IT WAS REPORTED THAT THE CATHETER WAS CORRECTLY WORKING BUT WHEN ABLATING IT MOVED A BIT AND PART OF THE HIS BUNDLE WAS BURNT. THE PATIENT NEEDED A PACEMAKER. ADDITIONALLY, THE REPORTER CONFIRMS THE ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS THAT IT WAS PATIENT CONDITION RELATED. THE PATIENTS OUTCOME WAS REPORTED AS UNCHANGED. EXTENDED HOSPITAL STAY WAS REQUIRED. FORCE VISUALIZATION FEATURES USED WERE GRAPH AND VECTOR.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16685982 ↗
• InjuryMay 26, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A FEMALE PATIENT (AGE IN 40S) UNDERWENT AN UNKNOWN ABLATION PROCEDURE WITH A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER. THE PATIENT SUFFERED COMPLETE HEART BLOCK. AFTER PROCEDURE, COMPLETE HEART BLOCK OCCURRED, AND A PACEMAKER WAS SCHEDULED TO BE INSERTED. THE PATIENT WAS AFFECTED. THE PHYSICIAN'S JUDGMENT ON HEALTH INJURY IS THAT IT IS SERIOUS. THE CAUSALITY WITH PRODUCT IS UNKNOWN. THERE WERE NO ABNORMALITIES OBSERVED BEFORE OR DURING USE OF THE PRODUCT. THE PLASTIC PART OF THE PIN BOX SLOT WAS BROKEN. THIS OCCURRED WHEN PREPARING THE PROCEDURE. PROCEDURE WAS CONTINUED AS-IS. VERSION INFORMATION - V7.1.80.33. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT PATIENT CONSEQUENCE. ADDITIONALLY, A SIGNAL NOISE OCCURRED ONLY IN LAB ON ABLATION CATHETER 1-2. CARTO 3 ELECTRICAL SIGNAL WAS DISPLAYED CLEARLY. THIS OCCURRED WHEN THE ABLATION CATHETER WAS INSERTED INTO THE CARDIAC CAVITY. THEY COMPLETED THE PROCEDURE BY INSERTING THE MAP 1 -2 IN THE ¿ICOUT¿ INTO ANOTHER LAB-PIN BOX; THE NOISE CONTINUED. THE CASE CONTINUED WITH A NOISE FILTER IN LAB. AFTER THAT, THE ABLATION CATHETER ELECTRICAL SIGNAL IN THE LABORATORY NATURALLY BECAME CLEAR. THERE WAS NO REPRODUCIBILITY IN P

  Patient problems: Heart Block

  MAUDE report 14504688 ↗
• InjuryMar 18, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT (APPROXIMATELY 55 KGS) UNDERWENT A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER AND SUFFERED A HEART BLOCK REQUIRING SURGICAL INTERVENTION AND PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT WHEN THE ABLATION WAS CONDUCTED, THE ATRIOVENTRICULAR (AV) INTERVAL WAS PROLONGED, RESULTING IN COMPLETE ATRIOVENTRICULAR BLOCK (AVB). THE PHYSICIAN COMMENTED THAT IT WAS NOT RELATED TO THE PRODUCT. THE COMPLAINT PRODUCT WILL NOT BE RETURNED FOR ANALYSIS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS THAT IT WAS THE PROCEDURE AND NOT RELATED WITH THE BWI PRODUCT. MEDICAL INTERVENTION PROVIDED WAS THE INSERTION OF A PACEMAKER. IT WAS REPORTED THAT THE AV BLOCK IMPROVED IN THE FOLLOW-UP AFTER COMPLETION OF THE PROCEDURE. THE PATIENT OUTCOME OF THE ADVERSE EVENT WAS REPORTED AS IMPROVED. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION OF ABOUT THREE DAYS DUE OF THE ADVERSE EVENT, FOR FOLLOW-UP. NO RELEVANT TESTS/LABORATORY DATA OR OTHER RELEVANT HISTORY WERE REPORTED. A SMARTABLATE GENERATOR WAS USED.

  Patient problems: Heart Block

  MAUDE report 13816280 ↗
• MalfunctionJan 6, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR RE-ENTRY TACHYCARDIA (AVRT) AND A WOLFF-PARKINSON-WHITE (WPW) PROCEDURE WITH A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER AND THE CATHETER SHAFT WAS BROKEN. IT WAS REPORTED THAT DURING THE PROCEDURE, AFTER REMOVING CATHETER FROM PATIENT, THE PHYSICIAN NOTICED THAT THE CATHETER WAS DAMAGED ON THE SHAFT AREA (PLASTIC WAS SCRATCHED/PEELED OFF THE SHAFT). PROCEDURE CONTINUED WITH A NEW CATHETER. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON THE EVENT. THE DAMAGE DID NOT RESULT IN WIRES BEING EXPOSED OR ANY LIFTED OR SHARP RINGS. THERE WAS NO RESISTANCE OR DIFFICULTY DURING INSERTION OR REMOVAL OF THE CATHETER. THE CATHETER WAS NOT PRE-SHAPED. THE SHEATH INFORMATION WAS NOT KNOWN. THE EVENT DESCRIBING THE ISSUE AS ¿PLASTIC WAS SCRATCHED/PEELED OFF THE SHAFT¿ WAS ASSESSED AS MDR REPORTABLE FOR CATHETER SHAFT WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13180382 ↗
• InjuryNov 30, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AN UNKNOWN MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER. THE PATIENT SUFFERED AV HEART BLOCK REQUIRING SURGICAL INTERVENTION. A TRANSIENT AV BLOCK OCCURRED DURING ABLATION AT THE SLOW IN A PROCEDURE OF NRT. THE EVENT OCCURRED THIRTY MINUTES AFTER USING THE NAVISTAR CATHETER. AFTER SIX MINUTES, AV CONNECTION RETURNED SPONTANEOUSLY. AFTER ABLATION OF THE SLOW, A TRANSIENT AV BLOCK OCCURRED IN THE PROCEDURE (FOR ABOUT SIX MINUTES). WITH A DISTANCE OF 20 MM FROM HIS, THE ABLATION TIME WAS ABOUT TWENTY SECONDS, AND THERE WAS NO PROBLEM WITH THE RESISTANCE VALUE AT 20W TO 25W. AT THE END OF THE STUDY, THE PQ RETURNED TO NORMAL AT 150MS, BUT THE PATIENT WAS DISCHARGED FROM THE ROOM WITH A TEMPORARY INSERTION FROM THE NECK. NON-SERIOUS (MODERATE/MINIMAL). THE CAUSALITY WITH THE PRODUCT WAS UNKNOWN. IT IS NOT CONSIDERED THAT THERE WAS A DEFECT IN THE PRODUCT. NO ABNORMALITIES WERE OBSERVED BEFORE OR DURING USE OF THE PRODUCTS. AT A LATER DATE, THE PATIENT DEVELOPED AV BLOCK AND A PERMANENT PACEMAKER WAS INSERTED. DETAILS OF HEALTH INJURY: TRANSIENT AV BLOCK¿AV BLOCK. SINCE THE EVENT IS LIFE THREATENING AND IT

  Patient problems: Heart Block

  MAUDE report 12897994 ↗
• InjurySep 1, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRY TACHYCARDIA (AVNRT) WITH A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER AND SUFFERED A COMPLETE HEART BLOCK REQUIRING A PERMANENT PACEMAKER. DURING THE PROCEDURE, THE PATIENT DEVELOPED A COMPLETE HEART BLOCK WHICH REQUIRED A PERMANENT PACEMAKER INSERTION. THE PATIENT WAS STABLE AND TRANSFERRED TO THE CRITICAL CARE UNIT FOR RECOVERY. THIS EVENT WAS DISCOVERED DURING POST USE OF BIOSENSE WEBSTER PRODUCT. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS UNKNOWN. THE PATIENT OUTCOME OF THE ADVERSE EVENT WAS FULLY RECOVERED AFTER PACEMAKER PLACEMENT. IT IS UNKNOWN IF THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT.

  Patient problems: Heart Block

  MAUDE report 12404358 ↗
• InjuryDec 22, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT CARDIAC ABLATION PROCEDURE FOR ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) WITH NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER AND SUFFERED HEART BLOCK REQUIRING TEMPORARY PACEMAKER IMPLANTATION. FIRST ABLATION (60 SEC) OF THE SLOW PATHWAY WITH PARTIAL SUCCESS. AFTER RE-INDUCTION, A SECOND ABLATION WAS ATTEMPTED. FORTY (40) SECONDS INTO THE ABLATION A STEAM POP OCCURRED. AND THE PATIENT DEVELOPED AN ATRIOVENTRICULAR (AV) BLOCK. A TEMPORARY PACEMAKER WAS IMPLANTED. THERE WAS NO TEMPERATURE RISE (BELOW 50 DEGREES ALWAYS) AND NO IMPEDANCE RISE NEITHER. BETWEEN NORMAL PARAMETERS. SMARTABLATE RF GENERATOR WAS USED WITH TEMPERATURE CONTROL MODE. THE EVENT OCCURRED DURING USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN¿S CAUSALITY OPINION WAS NOT PROVIDED. THE OUTCOME IS UNKNOWN. THERE WAS NO INFORMATION WHETHER THE PATIENT'S CONDITION REQUIRED EXTENDED HOSPITALIZATION. SINCE PACEMAKER WAS REQUIRED THE EVENT IS CODED AS COMPLETE HEART BLOCK.

  Patient problems: Heart Block

  MAUDE report 11055808 ↗
• InjuryJan 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. WHILE MAPPING AND ABLATING IN THE RIGHT VENTRICULAR OUTFLOW TRACT WITH A NAVISTAR CATHETER, A BLOOD PRESSURE DROP WAS NOTED. CARDIAC TAMPONADE WAS DIAGNOSED ON INTRACARDIAC ULTRASOUND. A PERICARDIOCENTESIS WAS PERFORMED, REMOVING 455 ML OF FLUID. THE PATIENT WAS STABLE AND REMAINED, SO ABLATION WAS CONTINUED. LATER IN THE PROCEDURE, ERROR CODE 40, MAP: DEFECTIVE CATHETER OR CABLE, APPEARED ON THE CARTO 3 SYSTEM WHEN THE SMART TOUCH SF CATHETER WAS CONNECTED. THE CABLE WAS EXCHANGED WITHOUT RESOLUTION. THE CATHETER WAS EXCHANGED, AND THE ERROR RESOLVED, CASE CONTINUED SUCCESSFULLY. THE PATIENT WAS STABLE AND SENT TO THE CORONARY CARE UNIT AFTER THE PROCEDURE. THE OBSERVED ERROR CODE 40 CARTO RECOGNITION ISSUE HAS BEEN ASSESSED AS NOT MDR REPORTABLE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS

  Patient problems: Cardiac Tamponade

  MAUDE report 9555884 ↗
• DeathMay 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT WITH HISTORY OF ATRIAL FIBRILLATION (AFIB) UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER AND A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER AND SUFFERED CARDIAC ARREST (REQUIRING SURGICAL INTERVENTION) AND DEATH. DURING THE PROCEDURE, A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER WAS INSERTED INTO THE PATIENT¿S BODY. AFTER MAPPING AND BEFORE ABLATION, THE PATIENT DEVELOPED ATRIAL FIBRILLATION. THE PHYSICIAN DECIDED TO CHANGE THE NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER TO A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER. FIVE MINUTES LATER, THE PHYSICIAN PREPARED TO SET UP THE MODEL, AND FOUND THE PATIENT HAD BECOME UNCONSCIOUS AND HYPOTENSIVE. THE PATIENT DEVELOPED CARDIAC ARREST. AN UNSPECIFIED SURGICAL INTERVENTION WAS PERFORMED; HOWEVER, PATIENT¿S CONDITION DID NOT IMPROVE AND ALTHOUGH THE PATIENT WAS RESUSCITATE ONCE, THE PATIENT EXPIRED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE DEATH IS THAT IT WAS CAUSED BY ACUTE HEART FAILURE OR MYOCARDIAL INFRACTION. NO BWI PRODUCT MALFUNCTIONS WERE REPORTED. BIOSENSE WEBSTER

  Patient problems: Cardiac Arrest; Death; No Code Available

  MAUDE report 8599462 ↗
• MalfunctionDec 5, 2018Crack; Crack

  IT WAS REPORTED A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER AND A DEFLECTION ISSUE OCCURRED. DURING THE OPERATION, THE CATHETER COULD NOT DEFLECT TO THE SPECIFICATION. A SECOND CATHETER WAS USED TO COMPLETE THE OPERATION AND THERE WERE NO REPORTED CONSEQUENCE OR INJURY TO THE PATIENT. THIS INITIALLY REPORTED EVENT HAS BEEN ASSESSED AS NOT REPORTABLE SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH IS REMOTE. ON (B)(6) 2018, THE BIOSENSE WEBSTER INC¿S FAILURE ANALYSIS LAB (FAL) RECEIVED THE DEVICE FOR EVALUATION AND INITIAL VISUAL ANALYSIS IDENTIFIED, ¿THE TIP IS BENT AND THE PEEK HOUSING IS LIFTED.¿ THESE FINDINGS HAVE BEEN REVIEWED AND ASSESSED AS MDR REPORTABLE MALFUNCTIONS. THIS EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF A REPORTABLE MALFUNCTION ON (B)(6) 2018 AND HAVE REASSESSED THE EVENT AS REPORTABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8135634 ↗
• InjuryAug 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) WITH A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER AND SUFFERED A TRANSIENT ATRIOVENTRICULAR HEART BLOCK REQUIRING A PACEMAKER IMPLANTATION. DURING ABLATION PHASE, A TRANSIENT OCCURRED. NO IMMEDIATE INTERVENTION WAS PERFORMED. THE PATIENT RECOVERED. REMAINDER OF THE PROCEDURE WAS ABORTED. ON POST-PROCEDURE DAY 1, ALTHOUGH THE ATRIOVENTRICULAR (AV) BLOCK WAS RECOVERED, A PACEMAKER WAS IMPLANTED AS IT MIGHT HAVE BECOME A SECOND-DEGREE AV-BLOCK (2:1). THERE¿S NO INFORMATION REGARDING EXTENDED HOSPITALIZATION OR PATIENT¿S OUTCOME. THE PHYSICIAN DID NOT ATTRIBUTE THE ADVERSE EVENT TO A BWI PRODUCT MALFUNCTION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GAIN CLARIFICATION ON THIS EVENT WITH NO RESPONSE. SHOULD ANY NEW INFORMATION BE OBTAINED IT WILL BE ASSESSED AND PROCESSED ACCORDINGLY.

  Patient problems: Arrhythmia; No Code Available

  MAUDE report 7833975 ↗
• InjuryJun 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) WITH A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER AND SUFFERED A HEART BLOCK AV REQUIRING SURGICAL INTERVENTION. PRIOR TO THE PROCEDURE, THE BLUE PIN BOX WAS DROPPED AND THE HOUSING THAT PLUGS INTO THE PATIENT INTERFACE UNIT (PIU) WAS BROKEN OFF. PIN BOX WAS REPLACED AND THE PROCEDURE CONTINUED. DURING THE PROCEDURE, WHEN THE NAVISTAR CATHETER WAS BEING POSITIONED NEAR THE ATRIOVENTRICULAR (AV) NODE/HIS REGION, THE PATIENT TOOK A DEEP BREATH AND INTRACARDIAC SIGNALS REVEALED A HEART BLOCK. RIGHT VENTRICULAR (RV) PACING WAS INITIATED. TEMPORARY PACEMAKER WAS INSERTED. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. PATIENT WILL REQUIRE 2-3 DAYS OF ADDITIONAL HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT TO MONITOR THE AV NODE. THERE IS NO PATIENT OUTCOME INFORMATION. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS RELATED TO THE PATIENT¿S CONDITION AND THE DEEP BREATH THE PATIENT TOOK WHILE THE NAVISTAR WAS BEING POSITIONED NEAR THE AV NODE/HIS REGION.

  Patient problems: Arrhythmia; Not Applicable

  MAUDE report 7573566 ↗
• MalfunctionFeb 14, 2018Signal Artifact/Noise; Pacing Problem; Signal Artifact/Noise; Pacing Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER. DURING THE PROCEDURE, THERE WAS NOISE ON THE NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER. IT WAS ALSO REPORTED THAT WHEN PACING, THE CATHETER PACED THROUGH ALL CHANNELS. THE CATHETER WAS REPLACED AND THE ISSUES RESOLVED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PACING LEADS WERE CONNECTED TO THE PRIMARY PACING PORT. THERE WAS UNWANTED PACING BEING DELIVERED AS THE SYSTEM PACED THROUGH ALL THE CHANNELS AT THE SAME TIME. NO ABLATION WAS PERFORMED BEFORE REPLACING THE NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER. THE BIOTRONIK PACING STIMULATOR WAS BEING USED DURING THE PROCEDURE. THE NOISE ISSUE WAS ASSESSED AS NOT REPORTABLE. ECG NOISE WAS ONLY INDICATED ON THE NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER. THEREFORE,THE RISK TO THE PATIENT WAS LOW. THE PACING ISSUE WAS ASSESSED AS A REPORTABLE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7272239 ↗
• InjuryFeb 14, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT)/ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) WITH A NAVISTAR CATHETER AND SUFFERED A HEART BLOCK AV THIRD DEGREE REQUIRING CARDIAC PACEMAKER INSERTION. DURING ABLATION, THE PATIENT WENT INTO A 2:1 HEART BLOCK. AFTER A 25 MINUTE WAITING PERIOD, A PERMANENT PACEMAKER WAS IMPLANTED. AT THE TIME OF PACEMAKER INSERTION, THE PATIENT WAS IN A STABLE ACCELERATED JUNCTIONAL RHYTHM. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. PATIENT REQUIRED ONE ADDITIONAL NIGHT OF HOSPITALIZATION AS A RESULT OF THIS ADVERSE EVENT. PATIENT FULLY RECOVERED WITH NO RESIDUAL EFFECTS. MEDICAL HISTORY INCLUDES JUVENILE DIABETES AND ANXIETY. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS NOT RELATED TO ANY BWI PRODUCT MALFUNCTION. GENERATOR SETTINGS INCLUDED POWER AT 50 WATTS AND TEMPERATURE AT 50 DEGREES CELSIUS.

  Patient problems: Complete Heart Block

  MAUDE report 6330580 ↗
• InjuryJan 6, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE FOR PREMATURE VENTRICULAR CONTRACTIONS (PVCS) WITH A NAVISTAR CATHETER AND SUFFERED A CARDIAC TAMPONADE (NO INTERVENTION REPORTED) AND CARDIAC ARREST (REQUIRING CARDIOPULMONARY RESUSCITATION). DURING ABLATION PHASE, 3 MINUTES AFTER THE LAST ABLATION, THE PATIENT BECAME HYPOTENSIVE AND A TAMPONADE WAS CONFIRMED VIA TRANSTHORACIC ECHOCARDIOGRAM. PATIENT ARRESTED AND CARDIOPULMONARY RESUSCITATION WAS INITIATED AND PATIENT WAS INTUBATED. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THIS ADVERSE EVENT. PATIENT OUTCOME IS IMPROVED. THERE WERE NO FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS RELATED TO PROCEDURE. TRANSSEPTAL PUNCTURE WAS NOT PERFORMED. NO SHEATH INFORMATION WAS REPORTED. GENERATOR PARAMETERS AT THE TIME OF INJURY INCLUDED TEMPERATURE CONTROL MODE WITH TEMPERATURE CUT-OFF AT 50 DEGREES CELSIUS AND POWER CUT-OFF AT 50 WATTS (NOT TITRATED). OVERALL ABLATION TIME AT THE SITE OF INJURY WAS APPROXIMATELY 3-5 MINUTES. LAST ABLATION

  Patient problems: Cardiac Arrest; Cardiac Tamponade; Low Blood Pressure/ Hypotension

  MAUDE report 6231370 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P990025. One submission often covers many models, so check the product and lot details in each record.

• Z-0369-2010 · Oct 2, 2008 · Terminated
  Biosense Webster NaviStar RMT Diagnostic/Ablation Steerable Tip 8mm DS Catheters; Part Numbers: D-1259-01 & D-1259-02