EZ Steer NAV BN7TCFJ4LRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10846835003031), received between Jun 20, 2016 and Apr 14, 2026 — classified as 17 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (9 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 16, 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.

• InjuryApr 14, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN SUPRAVENTRICULAR TACHYCARDIA (SVT) ABLATION PROCEDURE WITH AN EZ STEER NAV CATHETER AND THE PATIENT EXPERIENCED HEART BLOCK THAT REQUIRED A PACEMAKER IMPLANTATION. THEY PLANNED TO ABLATE THE SLOW PATHWAY WITH A 4 MM CATHETER. AFTER 20 SECONDS OF ABLATION, THE PATIENT WENT INTO AV BLOCK. SUBSEQUENTLY, THE PATIENT RECEIVED A PACEMAKER. THE PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION. THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT WAS INADVERTENT ABLATION OF THE AV NODE. THE PATIENT¿S OUTCOME WAS REPORTED TO BE STABLE WITH THE PACEMAKER.

  Patient problems: Heart Block

  MAUDE report 24873510 ↗
• MalfunctionMay 29, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) PROCEDURE WITH AN EZ STEER NAV AND OBSERVED THAT THE GAUZE WAS "CATCHING" ON THE CATHETER. IT WAS REPORTED THAT WHEN THE PHYSICIAN WAS WIPING DOWN THE CATHETER WITH A WET GAUZE, THE GAUZE WAS "CATCHING" ON THE CATHETER. THE CATHETER HAD NOT YET BEEN INSERTED IN THE BODY. THE CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS CONTINUED AND COMPLETED. ADDITIONAL INFORMATION WAS RECEIVED ON 05-MAY-2025. NO SIGN OF SHARP / ROUGH EDGES. ADDITIONAL INFORMATION WAS RECEIVED ON 29-MAY-2025 WHICH CLARIFIED THAT THE PHYSICIAN STATED THAT THE GAUZE WAS CATCHING ON THE DISTAL ELECTRODE. INITIALLY SINCE THE PHYSICIAN STATED THE GAUZE WAS CATCHING, THE BIOSENSE WEBSTER, INC. REPRESENTATIVE DID NOT CHECK IT. THE BIOSENSE WEBSTER, INC. REPRESENTATIVE REPLACED IT WITH THE SAME TYPE OF CATHETER. THE PHYSICIAN WIPED THE NEW ONE AND SAID THE NEW ONE WAS FINE. THE BIOSENSE WEBSTER, INC. REPRESENTATIVE THEN CHECKED THE ORIGINAL EZ STEER NAV CATHETER VISUALLY AND DID NOT SEE ANYTHING UNUSUAL AND ALSO PHYSICALLY RAN HIS FINGER ON IT AND DID NOT FEEL ANYTHING LIFTED OR SHARP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22110079 ↗
• InjuryJun 12, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH A EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND THE PATIENT EXPERIENCED HEART BLOCK THAT REQUIRED TEMPORARY PACEMAKER PLACEMENT. DURING AN AVNRT CASE, THE PATIENT WENT INTO HEART BLOCK WHILE ABLATING THE SLOW PATHWAY. THIS OCCURRED AFTER THE 6TH OR 7TH LESION. A TEMPORARY PACEMAKER WAS PROVIDED TO THE PATIENT INSTEAD OF A PERMANENT PACEMAKER TO ALLOW THE PATIENT SOME TIME TO THINK ABOUT THE DECISION FIRST. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PHYSICIAN DID NOT MENTION A SPECIFIC CAUSE FOR THE HEART BLOCK BUT THEY WERE NOT NEAR THE HIS WHILE ABLATING, BUT THE PHYSICIAN'S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS PROCEDURE-RELATED AS THE ABLATION WAS NEAR THE HIS BUNDLE. PATIENT IMPROVED BUT REQUIRED EXTENDED HOSPITALIZATION TO OBSERVE AND MONITOR THE HEART RATE TO SEE IF IT RETURNED TO SINUS RHYTHM.

  Patient problems: Heart Block

  MAUDE report 19523014 ↗
• InjuryAug 31, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL RE-ENTRANT TACHYCARDIA (AVNRT) ABLATION PROCEDURE THAT INCLUDED EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER. THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS AND PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT WHILE THEY WERE ABLATING, THE MONITORING NURSE NOTICED THE PATIENT'S BLOOD PRESSURE DROP TO 54 OVER 28 AND IMMEDIATELY NOTIFIED THE ANESTHESIOLOGIST AND THE PHYSICIAN. THEY CAME OFF ABLATION AND PUT IN AN ARTERIAL LINE AND USED A SOUNDSTAR CATHETER AND NOTED A PERICARDIAL EFFUSION OFF THE RIGHT VENTRICLE. THEY THEN PERFORMED A PERICARDIOCENTESIS AND 400 CCS OF FLUID FROM THE PATIENT AND MONITORED THE PATIENT WITH AN INTRACARDIAC ECHO UNTIL THE PATIENT WAS STABILIZED. THE PROCEDURE WAS CANCELED, AND THE PATIENT WAS THEN SENT TO THE INTENSIVE CARE UNIT TO RECOVER. IT IS UNKNOWN HOW LONG THE PATIENT STAYED IN THE HOSPITAL. THE PATIENT WAS STABLE AT THE TIME OF THE CALL. INITIALLY, THE PHYSICIAN DID NOT PROVIDE ANY OPINION ON WHAT COULD HAVE CAUSED THE ISSUE AS THEY HAD NO ERRORS AND NO HIGH READINGS ON ANY METRIC. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS REPORTED THAT

  Patient problems: Cardiac Tamponade

  MAUDE report 17662745 ↗
• InjuryAug 22, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION PROCEDURE THAT INCLUDED EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER. THE PATIENT EXPERIENCED HEART BLOCK THAT REQUIRED SURGICAL INTERVENTION. DURING THE PROCEDURE AFTER COMING ON ABLATION FOR 8 SECONDS, THEY NOTICED A LACK OF VENTRICULAR BEAT, A SPIKE IN IMPEDANCE, AND A LACK OF QRS AND IMMEDIATELY CAME OFF ABLATION AND DISCOVERED A HEART BLOCK. THE PATIENT IS NOW HAVING SURGERY TO IMPLANT A PERMANENT PACEMAKER INTO THE PATIENT. THE PATIENT IS NOW STABLE. THE PHYSICIAN STATED THAT THEY BELIEVE A STEAM POP MAY HAVE OCCURRED BUT THEY HAVE NOT CONFIRMED. ADDITIONAL INFORMATION WAS RECEIVED ON 01-AUG-2023. PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT: BWI PRODUCT MALFUNCTION 4MM - STEAM POP, PROCEDURE AVNRT ABLATION, PATIENT CONDITION COMPLETE HEART BLOCK. INTERVENTION PROVIDED WAS PERMANENT PACEMAKER 100% PACED. PATIENT FULLY RECOVERED. PATIENT REQUIRED OVERNIGHT STAY DUE TO PACEMAKER, DISCHARGED NEXT DAY. IMPEDANCE CUT OFF VALUES: LOW 60 AND HIGH 240 WITH NO DELTA. WITH THE REMOTE, USE WAS ABLE TO STOP THE ABLATION USING THE STOP BUTTON, ABLATION WAS STOPPED

  Patient problems: Heart Block

  MAUDE report 17600476 ↗
• MalfunctionJun 28, 2023Material Protrusion/Extrusion; Material Twisted/Bent; Material Protrusion/Extrusion; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT) PROCEDURE WITH AN EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND AN INTERNAL COMPONENTS EXPOSED ISSUE OCCURRED. IT WAS REPORTED BY THE BIOSENSE WEBSTER INC. (BWI) REPRESENTATIVE THAT DURING A PROCEDURE, THE PHYSICIAN NOTICED THAT THE CATHETER WAS NOT BENDING PROPERLY AND WHEN THE PHYSICIAN LOOKED ON FLOURO, HE COULD SEE THAT THE TIP WAS BENT AND HAD A KINK IN IT. TO TROUBLESHOOT, THE CATHETER WAS REPLACED, THE ISSUE WAS RESOLVED, AND THE PROCEDURE WAS CONTINUED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. THE DAMAGE RESULTED IN WIRES BEING EXPOSED. THE DAMAGE DID NOT RESULT IN ANY LIFTED OR SHARP RINGS. THERE WAS NO RESISTANCE OR DIFFICULTY DURING INSERTION OR REMOVAL OF THE CATHETER. THE ISSUE WAS FOUND BETWEEN THE DISTAL AND PROXIMAL ELECTRODES. THE BENT TIP ISSUE IS NOT MDR REPORTABLE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. THE INTERNAL COMPONENTS EXPOSED ISSUE IS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17218621 ↗
• InjurySep 1, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A 93-YEAR-OLD FEMALE PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRY TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH A EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER. THE PATIENT SUFFERED COMPLETE HEART BLOCK REQUIRING A TEMPORARY PACEMAKER AND SCHEDULED A PERMANENT PACEMAKER. UPON THE ABLATION ENDING, THE PATIENT WENT INTO COMPLETE HEART BLOCK. TEMPORARY PACING WAS BEING CONDUCTED AND THE PATIENT WAS SCHEDULED FOR A PERMANENT PACEMAKER. ADDITIONAL INFORMATION WAS RECEIVED. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT IT WAS PATIENT CONDITION RELATED. THE PATIENT RECEIVED A PACEMAKER. THE PATIENT OUTCOME WAS UNKNOWN BUT ASSUMED TO HAVE IMPROVED AFTER GETTING A PACEMAKER. THE PHYSICIAN BELIEVED THE RESULT WAS DUE TO WEAK CONDUCTION AFTER BEING IN TACHYCARDIA FOR SO LONG.

  Patient problems: Heart Block

  MAUDE report 15333063 ↗
• MalfunctionAug 10, 2022Material Protrusion/Extrusion; Patient Device Interaction Problem; Material Protrusion/Extrusion; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRY TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH AN EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND AN ELECTRODE DAMAGED WITHOUT FOREIGN MATERIAL ¿ SHARP ROUGH EDGES ISSUE OCCURRED. A STEAM POP WAS HEARD IN THE MIDDLE OF THE PROCEDURE. THE CATHETER WAS REMOVED FROM THE BODY AND THEY NOTICED THE INNER ELECTRODE HAD POPPED OUT OF THE BLUE LUMEN. NOTHING ELSE HAD FALLEN OUT OF THE CATHETER AND THE ELECTRODE WAS STILL ATTACHED. THE CATHETER WAS REPLACED WITH A SMARTTOUCH SF CATHETER AND THE ISSUE RESOLVED. ADDITIONAL INFORMATION WAS RECEIVED ON THE EVENT. THE DAMAGE WAS TO THE ELECTRODE, THERE WERE NO WIRES THAT THE BIOSENSE WEBSTER, INC. REPRESENTATIVE COULD SEE. THE ELECTRODE SEEMED LIKE SMOOTH EDGES. THERE WAS NO RESISTANCE OR DIFFICULTY DURING INSERTION OR REMOVAL OF THE DEVICE. THE ELECTRODE STAYED ATTACHED WITHIN THE LUMEN JUST A HOLE WAS CREATED WITH PART OF THE ELECTRODE EXPOSED. THE ELECTRODE WAS VISIBLE. NO SHEATH WAS USED. NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT HAS NOT EXHIBITED ANY NEUROLOGICAL SYMPTOMS SINCE THE PROCEDURE WAS COMPLETED. BASED ON THE AVAILABLE INFORMATION, THIS EVEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15196559 ↗
• InjuryApr 27, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AN UNKNOWN FEMALE PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT) ABLATION PROCEDURE WITH AN UNK_NAVISTAR RMT 4MM. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. IT WAS REPORTED THAT THE PATIENT HAD A CARDIAC EFFUSION DURING A SVT CASE. PRIOR TO NOTICING THE EFFUSION, THEY HAD DONE SEPTAL LESIONS ON THE RIGHT SIDE FOR ATRIOVENTRICULAR NODAL REENTRY TACHYCARDIA (AVNRT). FOR THOSE LESIONS THEY USED A 4MM NAVISTAR BI-DIRECTIONAL ABLATION CATHETER (FJ CURVE) AND THEN BEFORE GOING TRANSEPTAL THEY SWITCHED TO A SMART TOUCH SURROUND FLOW (STSF) CATHETER (DF CURVE). AFTER GOING TRANSEPTAL, WHILE THEY WERE GETTING READY TO MAP AND BEFORE ANY ABLATION WAS DONE WITH THE STSF CATHETER THEY NOTICED THE EFFUSION. IT IS UNKNOWN WHETHER THE BLOOD PRESSURE OR ANY OTHER METRICS CHANGED BEFORE IT WAS NOTICED. THE EFFUSION WAS CONFIRMED USING THE SOUNDSTAR CATHETER AND AN INTRACARDIAC ECHOCARDIOGRAM. AFTER THE EFFUSION WAS CONFIRMED, ALL INSTRUMENTS EXCEPT FOR THE SOUNDSTAR CATHETER WERE REMOVED FROM THE PATIENT AND THEY THEN PERFORMED A PERICARDIOCENTESIS. IT IS UNKNOWN HOW MUCH FLUID WAS REMOVED. NO OTHER MEDICAL INTERVENTION WAS NECESSARY BUT THE CA

  Patient problems: Cardiac Tamponade

  MAUDE report 14219691 ↗
• InjuryMar 15, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRY TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH AN EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER. THE PATIENT SUFFERED COMPLETE HEART BLOCK REQUIRING A TEMPORARY PACEMAKER AND PROLONGED HOSPITALIZATION. DURING AN AVNRT CASE, A COMPLETE HEART BLOCK WAS NOTICED IN THE PATIENT AFTER USE OF A BWI CATHETER. THERE WAS ABOUT 1-2 SECONDS AFTER COMING OFF ABLATION AND COMPLETE HEART BLOCK WAS NOTICED IMMEDIATELY, VIA THE ELECTROCARDIOGRAM (EKG) SIGNALS ON THE RECORDING SYSTEM. THE COMPLETE HEART BLOCK WAS CONFIRMED VIA THE RECORDING SYSTEM. A TEMPORARY PACEMAKER WAS PLACED IN THE PATIENT AND THE PATIENT IS BEING HELD OVERNIGHT FOR MONITORING. THE COMPLETE HEART BLOCK LASTED FOR ABOUT 20 MINUTES, AND THEN THE PATIENT HAD ONE TO ONE CONDUCTION. AFTER DISCUSSING WITH THE PHYSICIAN, THEY DID NOT SEE ANY HIS (BUNDLE OF HIS) ON THE TIMELINE RETROSPECTIVELY. THE HAD ONLY ABLATED FOR 1 MINUTE AND THE CATHETER SHOWED ON THE TIMELINE BUT IT DID NOT MOVE BEYOND THE LOCATION THEY HAD ORIGINALLY ABLATED. EVERYTHING WAS DONE CORRECTLY, BUT THE PHYSICIAN BELIEVES THAT CONDUCTIVE HEATING DID NOT STOP AFTER THEY CAME OFF A

  MAUDE report 13767987 ↗
• MalfunctionJun 11, 2021Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRY TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH AN EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND CARTO® 3 SYSTEM AND THERE WAS SIGNAL INTERFERENCE ON ALL ECG (INTRACARDIAC AND BODY SURFACE) ON THE CARTO® 3 SYSTEM, RECORDING SYSTEM AND ANESTHESIA MONITOR. INITIALLY, IT WAS REPORTED THAT DURING ABLATION, SPIKE SIGNALS WOULD APPEAR ON ALL THE SIGNALS INTERMITTENTLY. THE CATHETER CABLE WAS REPLACED WITH NO RESOLUTION. THE PUMP WAS TURNED OFF WITH NO RESOLUTION. THE GROUNDING CABLES WERE CHECKED, AND THE PUMP WAS GROUNDED WITH NO RESOLUTION. THE CASE WAS COMPLETED WITH THE ISSUES AND NO FURTHER TROUBLESHOOTING WAS PERFORMED. NO PATIENT CONSEQUENCE WAS REPORTED. WITH THE INFORMATION AVAILABLE, THIS EVENT WAS ASSESSED AS NOT MDR REPORTABLE SINCE THERE WAS NO EVIDENCE THAT THE PATIENT'S HEART RHYTHM WAS NOT VISIBLE TO THE OPERATOR ON ALL ELECTROGRAMS (BODY SURFACE AND INTRACARDIAC) ON ALL SYSTEMS AVAILABLE. THEREFORE, THE RISK TO THE PATIENT WAS LOW. ADDITIONAL INFORMATION WAS REQUESTED AND A RESPONSE WAS RECEIVED ON MAY 19, 2021. THE SIGNAL INTERFERENCE (NOISE) WAS OBSERVED ON ALL ECG (INTRACARDIAC AND BO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11984985 ↗
• InjuryApr 1, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH A EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND SUFFERED ATRIOVENTRICULAR (AV) HEART BLOCK REQUIRING SURGICAL INTERVENTION (PACEMAKER IMPLANTATION). THE EVENT OCCURRED ON (B)(6) 2021. THE ADVERSE EVEN WAS DISCOVERED DURING THE USE OF THE BWI PRODUCTS. THE HEART BLOCK WAS DISCOVERED AND CONFIRMED VIA BODY SURFACE ELECTROGRAMS. THE PHYSICIANS BELIEVES THAT THE CAUSE WAS RELATED TO PATIENT CONDITION AND PROCEDURE. INTERVENTION WAS EXTERNAL PACING AND THE IMPLANTATION OF A PERMANENT PACEMAKER. THE PATIENT WAS IN STABLE CONDITION LEAVING THE EP LAB. PATIENT¿S CURRENT CONDITION IS UNKNOWN. THE PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION. NO BWI PRODUCT MALFUNCTIONS WERE REPORTED. SINCE THE EVENT REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION, OR PERMANENT DAMAGE OF A BODY STRUCTURE, THEN IS TO BE CONSIDERED SERIOUS AND MDR-REPORTABLE.

  Patient problems: Heart Block

  MAUDE report 11600774 ↗
• MalfunctionJan 21, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) PROCEDURE WITH AN EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND THE STERILIZATION WAS COMPROMISED. IT WAS REPORTED THAT THE INSIDE STERILE PACKAGING OF THE CATHETER WAS COMPROMISED. THE CATHETER WAS NOT USED ON THE PATIENT. A NEW CATHETER WAS OPENED AND THE PROCEDURE WAS CONTINUED WITHOUT PATIENT CONSEQUENCES. THE CATHETER STERILIZATION COMPROMISED ISSUE WAS ASSESSED AS REPORTABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9609496 ↗
• InjuryNov 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN ATRIAL TACHYCARDIA (AT) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, POST ABLATION PHASE, DURING USE OF BOTH THE THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER, A CARDIAC TAMPONADE WAS DISCOVERED AND CONFIRMED BY ECHOCARDIOGRAM. THE PHYSICIAN PERFORMED A PERICARDIOCENTESIS AND AN UNKNOWN AMOUNT OF FLUID WAS REMOVED. THE PATIENT WAS STABLE AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) FOR OBSERVATION. IT IS UNKNOWN IF THE PATIENT REQUIRED EXTENDED HOSPITALIZATION OR THE OUTCOME OF THE ADVERSE EVENT. THE PHYSICIAN WAS UNSURE OF WHAT CAUSED THE EVENT. HOWEVER, THE FLUID THAT WAS COLLECTED AFTER THE PERICARDIOCENTESIS WAS MOSTLY CLEAR. IT WAS THOUGHT TO HAVE BEEN FROM THE THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER. THE PATIENT HAD A PREPROCEDURAL DIAGNOSIS OF SUPRAVENTRICULAR TACHYCARDIA (SVT) AND ENDED UP AS AN ATRIAL TACHYCARDIA (AT). NO TRANSSEPTAL PUNCTURE

  Patient problems: Cardiac Tamponade

  MAUDE report 9292192 ↗
• InjuryMay 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR REENTRANT TACHYCARDIA (AVRT)/WOLFF-PARKINSON-WHITE SYNDROME (WPW) ABLATION PROCEDURE WITH AN EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, WHEN THE AGILIS SHEATH WAS ADVANCED OVER THE BIOSENSE WEBSTER INC. (BWI) ABLATION CATHETER, THE CATHETER TIP DID NOT DISAPPEAR, LEADING THE PHYSICIAN TO BELIEVE THE SHEATH WAS MORE PROXIMAL THAN IT WAS. THE SHEATH CONTINUED TO BE ADVANCED AND PERFORATED THE RIGHT ATRIAL APPENDAGE. THE PATIENT BECAME HYPOTENSIVE, AND CARDIAC TAMPONADE WAS CONFIRMED BY TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 260 CC OF FLUID FROM THE PERICARDIUM. THE PATIENT WAS REPORTED IN STABLE CONDITION. THERE¿S NO INFORMATION REGARDING EXTENDED HOSPITALIZATION OR PHYSICIAN CAUSALITY OPINION. NO BWI PRODUCT MALFUNCTIONS WERE REPORTED. IT WAS REPORTED THAT THE AGILIS SHEATH (NON-BWI PRODUCT) PERFORATED THE RIGHT ATRIAL APPENDAGE; HOWEVER, THE BWI ABLATION CATHETER WAS ALSO IN USE AT THAT TIME. WITH THE AVAILABLE INFORMATION, IT CANNOT BE CONFIRMED THE USAGE OF THE BWI PRODUCT DID NOT CON

  Patient problems: Cardiac Tamponade

  MAUDE report 8655783 ↗
• InjuryMar 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRY TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH AN EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND SUFFERED HEART BLOCK ATRIOVENTRICULAR (AV) REQUIRING SURGICAL INTERVENTION. DURING THE ABLATION PHASE, THERE WAS A COMPLETE HEART BLOCK. AFTER COMING OFF ABLATION, THE PATIENT WAS DISPLAYING SOME TEMPORARY AV NODE FUNCTION BUT HAS NOT COMPLETELY RECOVERED. TEMPORARY PACEMAKER WIRE WAS INITIALLY IMPLANTED. EXTENDED HOSPITALIZATION WAS REQUIRED. THE PATIENT WAS KEPT OVERNIGHT FOR OBSERVATION PURPOSES. THE NATIVE CONDUCTION DID NOT COME BACK, AND PERMANENT PACEMAKER WAS THEN IMPLANTED. PATIENT¿S CONDITION IMPROVED AFTER THE PLACEMENT OF THE PERMANENT PACEMAKER. THE PHYSICIAN DID NOT EXPRESS A SPECIFIC OPINION TO ME ABOUT WHAT CAUSED THE ADVERSE EVENT. HOWEVER, IT IS NOT BELIEVED THAT ANY BIOSENSE WEBSTER INC. PRODUCT ATTRIBUTED TO THE CAUSALITY OF THE EVENT.

  Patient problems: Arrhythmia; No Code Available

  MAUDE report 8435780 ↗
• InjuryJan 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIOVENTRICULAR NODAL REENTRY TACHYCARDIA ("AVRNT") WITH AN EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND SUFFERED HEART BLOCK AV REQUIRING NO MEDICAL/SURGICAL INTERVENTION. DURING THE PROCEDURE, HEART BLOCK AV WAS NOTICED. THE ATRIAL BEATS WERE NOT ONE TO ONE WITH THE VENTRICULAR BEATS. THE VENTRICLE WAS BEING PACED DUE TO THE PATIENT HAVING A DEVICE. THE HEART BLOCK DID NOT NEED ANY TYPE OF MEDICAL INTERVENTION. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. IT IS UNKNOWN IF EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT. PATIENT¿S OUTCOME IS UNCHANGED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT OCCURRED DUE TO ABLATING ON THE NODE.

  Patient problems: Complete Heart Block

  MAUDE report 8258003 ↗
• InjuryJun 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WEIGHING APPROXIMATELY (B)(6) UNDERWENT AN ABLATION PROCEDURE FOR SUPRAVENTRICULAR TACHYCARDIA (SVT)/ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) WITH AN EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND SUFFERED A HEART BLOCK AV REQUIRING A SURGICAL INTERVENTION. DURING ABLATION, THE ATRIOVENTRICULAR (AV) NODE WAS INADVERTENTLY ABLATED. HEART BLOCK OCCURRED AND A PACEMAKER WAS INSERTED. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) FOR OBSERVATION AND ADMITTED TO THE HOSPITAL. WHILE IN THE ICU, PATIENT¿S RHYTHM RECOVERED AND A PERMANENT PACEMAKER WAS NO LONGER NECESSARY. PATIENT FULLY RECOVERED WITH NO RESIDUAL EFFECTS. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS RELATED TO PATIENT MOVEMENT DURING ABLATION. THERE WERE NO ISSUES, ERRORS, OR MALFUNCTIONS REPORTED ON ANY BIOSENSE WEBSTER, INC. PRODUCTS OR EQUIPMENT DURING THE PROCEDURE.

  Patient problems: Complete Heart Block; No Code Available

  MAUDE report 7630579 ↗
• InjuryMar 20, 2018Adverse 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 AN ABLATION PROCEDURE FOR SUPRAVENTRICULAR TACHYCARDIA (SVT) WITH AN EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND SUFFERED A HEART BLOCK AV REQUIRING SURGICAL INTERVENTION. DURING ABLATION, A HEART BLOCK (DEGREE-UNSPECIFIED) WAS CONFIRMED VIA ELECTROCARDIOGRAM. A PERMANENT PACEMAKER WAS IMPLANTED. POST-PACEMAKER, THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND HAD RETURNED TO BASELINE. PATIENT REQUIRED AN OVERNIGHT STAY IN THE HOSPITAL TO RECOVER FROM PACEMAKER IMPLANTATION. PATIENT FULLY RECOVERED WITH NO RESIDUAL EFFECTS. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS RELATED TO PATIENT CONDITION, AS MEDICAL HISTORY INCLUDES BRADYCARDIA, SYNCOPE, AND HEART BLOCK.

  Patient problems: Arrhythmia; No Code Available

  MAUDE report 7355651 ↗
• InjuryNov 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH AN EZ STEER NAVIGATIONAL 4MM CATHETER AND SUFFERED A HEART BLOCK REQUIRING A TEMPORARY PACEMAKER. DURING ABLATION, THE PATIENT WENT INTO A TRANSIENT HEART BLOCK THAT REVERTED BACK TO SINUS RHYTHM. THE HEART BLOCK RETURNED DURING ANOTHER RADIOFREQUENCY LESION AND PERSISTED. LEFT VENTRICULAR PACING WAS INITIATED VIA THE ST. JUDE MEDICAL QUAD CATHETER WHILE TEMPORARY PACEMAKER WAS BEING PLACED. PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT TO ASSESS FOR ATRIOVENTRICULAR (AV) NODE RECOVERY. AV NODE RECOVERED AND NO PERMANENT PACEMAKER WAS NEEDED. TEMPORARY PACEMAKER WAS REMOVED AND THE PATIENT WAS SCHEDULED TO BE DISCHARGED TO HOME. PATIENT FULLY RECOVERED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS RELATED TO ABLATING TOO CLOSE TO THE ATRIOVENTRICULAR (AV) NODE.

  Patient problems: No Code Available

  MAUDE report 7007410 ↗
• InjuryApr 26, 2017Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIOVENTRICULAR REENTRANT TACHYARDIA (AVRT)/WOLFF-PARKINSON-WHITE (WPW) WITH AN EZ STEER NAVIGATIONAL 4MM CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. THE PATIENT¿S MEDICAL HISTORY WAS UNKNOWN. DURING ABLATION OF AN ACCESSORY PATHWAY NEAR THE CORONARY SINUS OSTIUM, A STEAM POP OCCURRED. TEN MINUTES LATER, THE PATIENT BECAME HYPOTENSIVE, AND A RIGHT VENTRICULAR TAMPONADE WAS CONFIRMED VIA TRANSTHORACIC ECHOCARDIOGRAM. PERICARDIOCENTESIS YIELDED 227ML. REMAINDER OF PROCEDURE WAS ABORTED. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. PATIENT WAS TRANSFERRED FOR OBSERVATION. THERE IS NO INFORMATION ABOUT THE HOSPITALIZATION. THE PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION FOR THE CAUSE OF THIS ADVERSE EVENT. SMARTABLATE GENERATOR SETTINGS INCLUDED MAXIMUM POWER AT 50 WATTS WITH MAXIMUM IMPEDANCE AT 148 OHMS. 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 OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STR

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension

  MAUDE report 6524825 ↗
• Jan 2, 2017Material Protrusion/Extrusion; Physical Property Issue

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH AN EZ STEER NAVIGATIONAL 4MM CATHETER WHERE THE CATHETER HAD EXPOSED WIRING NEAR ELECTRODE #3. PER THE ELECTROPHYSIOLOGIST, THERE WAS A SMALL INTERRUPTION IN THE INSULATION NEAR THE THIRD ELECTRODE, EXPOSING SOME OF THE INTERNAL WIRING. IT IS NOT KNOWN IF THE DAMAGE RESULTED IN ANY LIFTED OR SHARP RINGS. NO DIFFICULTY WAS REPORTED REGARDING INSERTION OR REMOVAL OF THE CATHETER FROM THE PATIENT. THE CATHETER WAS REPLACED, AND THE CASE WAS CONTINUED WITHOUT ANY REPORT OF PATIENT CONSEQUENCE. EXPOSURE TO THE INTERNAL COMPONENTS OF THE CATHETER PRESENTS A CRITICAL RISK OF THROMBUS TO THE PATIENT. AS A RESULT, THIS EVENT IS MDR REPORTABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6217112 ↗
• MalfunctionOct 10, 2016Break; Detachment Of Device Component; Peeled/Delaminated

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA PROCEDURE WITH AN 7F ES STEER DS BI-DIRECTIONAL NAV CATHETER AND THE CATHETER TIP WAS BROKEN. WHEN THE CATHETER WAS REMOVED FROM THE PATIENT, AFTER SOME ABLATIONS HAD BEEN DONE, SOMETHING WAS ON THE TIP OF THE CATHETER. THE PHYSICIAN SAID IT WAS NOT TISSUE OR CHAR BUT LOOKED LIKE A COATING ON THE TIP WAS PEELING OFF. THE MATERIAL SEEMED TO BE PART OF THE COVERING OF THE CATHETER. THE CATHETER WAS REPLACED THE CASE WAS CONTINUED AND COMPLETED WITH NO PATIENT CONSEQUENCE. THIS EVENT IS MDR REPORTABLE BECAUSE THE RISK TO THE PATIENT IS CRITICAL DUE TO THE POTENTIAL OF THROMBUS FROM EXPOSURE OF INTERNAL CATHETER COMPONENTS, OR DUE TO RISK OF COMPLETE SEPARATION OF THE TIP OR TIP COMPONENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6014144 ↗
• InjuryJun 20, 2016Insufficient Device Problem Information

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR SUPRAVENTRICULAR TACHYCARDIA (SVT) WITH AN EZ STEER NAVIGATIONAL 4MM CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING ABLATION PHASE, THE PATIENT BECAME HYPOTENSIVE AND TAMPONADE WAS CONFIRMED VIA ECHOCARDIOGRAM. PERICARDIOCENTESIS YIELDED AN UNKNOWN AMOUNT OF FLUID. PATIENT WAS REPORTED TO BE IN STABLE CONDITION UPON LEAVING THE LAB. PATIENT REQUIRED AN OVERNIGHT STAY IN THE HOSPITAL FOR OBSERVATION. PATIENT OUTCOME IS IMPROVED. THERE WERE NO FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION. NO TRANSSEPTAL PUNCTURE WAS PERFORMED. THERE IS NO INFORMATION REGARDING ANY SHEATH USED. GENERATOR PARAMETERS AT THE TIME OF INJURY: TEMPERATURE CONTROL MODE WITH POWER AT 20 WATTS (NOT TITRATED) AND IMPEDANCE OF APPROXIMATELY 110 OHMS. OVERALL ABLATION TIME AT THE SITE OF INJURY WAS APPROXIMATELY 20 SECONDS WITH LAST ABLATION CYCLE TIME AT APPROXIMATELY 10 SECONDS. THERE WERE NO ERROR MESSAGES OBSERVED ON BWI EQUIPMENT DURING THE PROCEDURE. THERE IS NO INFORMATION REGARDING ANTICOAGULANTS USED DURING THE PROCEDURE.

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension

  MAUDE report 5735889 ↗

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