Webster CS BD710FJ282CTRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10846835002423), received between Jan 8, 2018 and Jan 27, 2026 — classified as 3 deaths, 6 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K101345); 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJan 27, 2026Patient Device Interaction Problem

  DURING A PERSISTENT ATRIAL FIBRILLATION (PAF) ABLATION WHILE USING A WEBSTER CS (CORONARY SINUS) CATHETER, THE PATIENT EXPERIENCED PERICARDIAL EFFUSION TREATED CONFIRMED WITH ICE (INTRACARDIAC ECHOCARDIOGRAPHY) CATHETER AND TREATED WITH PERICARDIOCENTESIS AND REMOVAL OF 19ML OF FLUID. PRIOR TO GAINING TRANSSEPTAL ACCESS, THE PATIENT'S BLOOD PRESSURE BEGAN TO DECREASE. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE THE PATIENT WAS KEPT FOR A COUPLE OF DAYS FOR MONITORING THE EFFUSION, AND A TEE (TRANSESOPHAGEAL ECHOCARDIOGRAM) BEING PERFORMED. THE OUTCOME OF THE ADVERSE EVENT FULLY RECOVERED (NO RESIDUAL EFFECTS). THE WEBSTER CS CATHETER IS NOT AVAILABLE FOR RETURN. FARAPULSE SYSTEM WAS PLANNED FOR USE, BUT NO PFA (PULSE FIELD ABLATION) ABLATION WAS PERFORMED. THE FOLLOWING BWI DEVICES WERE ALSO IN USE SOUNDSTAR CATHETER (NOT AVAILABLE FOR RETURN), CARTO 3 SYSTEM. THE WEBSTER CS CATHETER AND THE SOUNDSTAR CATHETER WERE BOTH BRAND NEW. THE INFORMATION RECEIVED INDICATED THAT THIS ADVERSE EVENT WAS DISCOVERED AFTER THE WEBSTER WAS USED ON THE PATIENT. THE PHYSICIAN WAS UNSURE OF WHAT CAUSED THE EVENT. NO TRANSSEPTAL PUNCTURE WAS PERFORMED, BUT VERSACROSS CONNECT LAAC ACCESS SOL

  Patient problems: Cardiac Tamponade

  MAUDE report 24191085 ↗
• MalfunctionApr 30, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A WEBSTER CS CATHETER. WHILE OPENING UP THE WEBSTER CS CATHETER, OBSERVED THE CATHETER CONTAMINATED WITH A HUMAN HAIR. REPLACED THE CATHETER TO CONTINUE WITH THE PROCEDURE. THERE WAS 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 21937029 ↗
• DeathAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ISCHEMIC VENTRICULAR TACHYCARDIA (ISVT) ABLATION PROCEDURE WITH A WEBSTER CS AND A CRISTA CATH AND THE PATIENT EXPERIENCED CARDIAC ARREST AND HEMORRHAGE THAT RESULTED IN DEATH. THE PATIENTS PRESSURE DROPPED SIGNIFICANTLY DURING TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) PRIOR TO TRANSEPTAL PUNCTURE. AFTER THIS WAS NOTICED, CARDIOPULMONARY RESUSCITATION (CPR) WAS ADMINISTERED. THE PATIENTS' PRESSURE WOULD RECOVER SLIGHTLY AND THEN FALL AGAIN - ALL WHILE GOING IN AND OUT OF VENTRICULAR TACHYCARDIA (VT). PATIENT WAS SHOCKED BACK INTO NORMAL RHYTHM WHEN NEEDED. INTERVENTIONAL RADIOLOGY (IR) WAS CALLED TO CHECK FOR AORTIC AND RETROPERITONEAL BLEED WITH NO FINDINGS. CARDIO VASCULAR (CV) SURGERY WAS CALLED AND PLACED THE PATIENT ON ECMO. THE PATIENT WAS STABLE AND ON ECMO AND THEN SHORTLY AFTER THE PATIENT STARTED TO CODE. CV SURGERY, IR AND EPS WERE ALL IN THE ROOM ATTEMPTING TO FIGURE OUT THE PROBLEM. IT WAS NOTICED THE PATIENT¿S ABDOMEN WAS DISTENDED. PHYSICIANS SURGICALLY OPENED THE BELLY AND FOUND THE ABDOMEN WAS FULL OF BLOOD. AFTER A LONG-STANDING EFFORT, ANESTHESIA SAID THE PUPILS WERE NON-REACTIVE AND BLOWN. THE CAUSE OF THE BLEED REMAINS UNK

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20022344 ↗
• InjuryJun 20, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EP (ELECTROPHYSIOLOGY) STUDY PROCEDURE WITH A WEBSTER ® CS CATHETER WITH EZ STEER¿ TECHNOLOGY. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. IT WAS REPORTED THAT AFTER AN EP STUDY HAD COMPLETED, A PERICARDIAL EFFUSION WAS NOTICED IN THE PATIENT. THE MEDICAL TEAM REPORTED THAT THE PATIENT WAS INITIALLY COMPLAINING OF CHEST PAIN, IN THE POST-OP AREA. THE PERICARDIAL EFFUSION WAS VISUALIZED AND CONFIRM ON ULTRASOUND. THE PATIENT WAS THEN ADMITTED TO THE CATH LAB, AND A "DRAIN" WAS ADMINISTERED TO THE PATIENT. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS, AND ABOUT 350CC OF FLUID WAS REMOVED. THE PATIENT IS IN STABLE CONDITION. THE ADVERSE EVENT OCCURRED ON (B)(6) 2023. ADVERSE EVENT DISCOVERED AFTER USE OF BWI PRODUCT WHEN PATIENT HAD LEFT PROCEDURE ROOM AND WAS IN RECOVERY. DR'S OPINION WAS THAT EVENT WAS CAUSED BY PATIENT MOVEMENT DURING PROCEDURE. INTERVENTION PROVIDED WAS EMERGENT PERICARDIOCENTESIS PERFORMED IN CATH LAB. DRAIN REMAINED. OUTCOME OF THE ADVERSE EVENT WAS FULL RECOVERY. PATIENT WAS STABLE. PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT AS DRAIN WAS PLACED AND P

  Patient problems: Cardiac Tamponade

  MAUDE report 17160592 ↗
• InjuryMay 15, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PVI AND CTI ABLATION PROCEDURE WITH AN UNKNOWN SMART TOUCH BIDIRECTIONAL SF. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. IT WAS REPORTED THAT ATRIAL FIBRILLATION AND TYPICAL FLUTTER WERE TREATED. A CS (CORONARY SINUS) BIDIRECTIONAL, LASSO NAV AND STSF WERE USED DURING THE PROCEDURE. THE PATIENT WAS SUCCESSFULLY ABLATED AND TRANSFERRED TO SINUS RHYTHM. AN ECHO WAS TAKEN AFTER THE PROCEDURE WITH NO COMPLICATIONS. 2 HOURS AFTER THE PROCEDURE, THE PATIENT'S PRESSURE DROPPED, SO SHE HAD TO GO BACK TO THE LAB. A PERICARDIAL EFFUSION WAS DIAGNOSED AND 1.6L BLOOD WAS TAKEN. THE PATIENT HAD TO BE TRANSFERRED TO ANOTHER HOSPITAL. A SURGICAL PROCEDURE WAS PERFORMED. THE DOCTOR SUSPECTS THAT THE PERICARDIAL EFFUSION (PE) WAS CAUSED BY THE CS. THE PROCEDURE DATE AND EVENT DATE WAS (B)(6) 2023, 16:00. THE NAME OF THE PROCEDURE PERFORMED WAS PVI (PULMONARY VEIN ISOLATION) AND CTI (CAVOTRICUSPID ISTHMUS) ABLATION, BECAUSE OF AFIB AND TYPICAL FLUTTER. THE PRODUCT NUMBER OF THE CS CATHETER IS 36G5JMCT. DON¿T HAVE A PICTURE OF THE LABEL, BECAUSE THE CATHETER WAS DISCARDED AFTER THE PROCEDURE. IT WILL NOT BE POSSIBLE TO OBTAIN THE L

  Patient problems: Cardiac Tamponade

  MAUDE report 16932673 ↗
• MalfunctionNov 28, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A WEBSTER ® CS CATHETER WITH EZ STEER¿ TECHNOLOGY AND A BROKEN TIP ISSUE OCCURRED. IT WAS REPORTED THAT THE DISTAL TIP OF THE A WEBSTER ® CS CATHETER WITH EZ STEER¿ TECHNOLOGY WAS BENT, AND IT LOOKED LIKE A PIECE OF METAL WAS POKING OUT OF THE SIDE OF THE TIP. BWI REPRESENTATIVE STATED THIS WAS DISCOVERED RIGHT OUT OF THE PACKAGE. THE CATHETER WAS REPLACED AND THE ISSUE RESOLVED. THE DAMAGE DID NOT RESULT IN WIRES BEING EXPOSED AND DID NOT RESULT IN ANY LIFTED OR SHARP RINGS. THE ISSUE WAS FOUND PROXIMAL TO ELECTRODE 2 FROM THE DISTAL END OF THE CATHETER. THE CATHETER WAS NOT PRE-SHAPED. DAMAGE WAS NOTICED BEFORE ATTEMPTING TO PLACE IN THE PATIENT¿S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15868182 ↗
• InjurySep 13, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A 69-YEAR-OLD MALE PATIENT (110 KGS) UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB)ABLATION PROCEDURE WITH A NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER AND A WEBSTER ® CS CATHETER WITH EZ STEER® TECHNOLOGY AND AUTO ID. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT AFTER THE ABLATION, THE PATIENT SUFFERED A PERICARDIAL EFFUSION. IT WAS DISCOVERED WHILE THE PATIENT WAS STILL ON THE PROCEDURE TABLE, AFTER CATHETER REMOVAL, USING TRANSTHORACIC ECHO. THE CALLER WAS UNCERTAIN IF THE PATIENT'S BLOOD PRESSURE WAS AFFECTED. A PERICARDIOCENTESIS WAS ONGOING AT THE TIME OF THE CALL. THE PATIENT REMAINED STABLE. THE PHYSICIAN DID NOT INDICATE THAT THEY BELIEVED BIOSENSE WEBSTER, INC. PRODUCTS CONTRIBUTED TO THE PATIENT EVENT. ADDITIONAL INFORMATION WAS RECEIVED. THIS ADVERSE EVENT WAS DISCOVERED POST USE OF BIOSENSE WEBSTER PRODUCTS. PERICARDIOCENTESIS WAS PERFORMED, NO OTHER INTERVENTION NECESSARY. THE PATIENT¿S CURRENT CONDITION IS UNKNOWN, BUT PATIENT WENT HOME. PATIENT STAYED IN HOSPITAL FOR 2 DAYS, WOULD HAVE ONLY BEEN HERE FOR THE DAY IF PROCEDURE WENT ACCORDING TO PLAN. TRANSSEPTA

  Patient problems: Cardiac Tamponade

  MAUDE report 15408207 ↗
• MalfunctionFeb 6, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A WEBSTER CS CATHETER AND THERE WAS AN OPEN POUCH SEAL ISSUE. WHEN OPENING THE CATHETER, THE PACKAGING WAS ALREADY OPENED. THE CATHETER WAS REPLACED AND THE ISSUE RESOLVED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THE EVENT WAS ASSESSED AS A MDR REPORTABLE OPEN POUCH SEAL ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13467148 ↗
• MalfunctionOct 25, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A WEBSTER ® CS CATHETER WITH EZ STEER® TECHNOLOGY AND AUTO ID AND AN ISSUE WITH FOREIGN MATERIAL IN THE STERILE PACKAGE OCCURRED. WHEN THE NURSE TOOK THE PACKAGE OUT OF THE BOX, A BLACK PIECE OF SOMETHING CIRCULAR AND HARD WAS NOTICED INSIDE THE STERILE PACKAGE. IT COULD BE FELT FROM THE BACK SIDE OF THE PACKAGING. THE STERILE PACKAGE WAS NOT OPENED, AND THE DEVICE WAS NOT USED ON THE PATIENT. THE CATHETER WAS EXCHANGED, AND THE ISSUE WAS RESOLVED, AND THE CASE WAS CONTINUED WITHOUT ANY FURTHER INCIDENT. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12693828 ↗
• MalfunctionMar 12, 2021Contamination /Decontamination Problem; Material Twisted/Bent; Contamination /Decontamination Problem; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, RIGHT AFTER THE WEBSTER ® CS CATHETER WITH EZ STEER® THECHNOLOGY AND AUTO ID WAS REMOVED FROM THE BOX, IT WAS NOTICED IT HAD A BENT OF ALMOST 50-DEGREE ANGLE. THE CATHETER APPEARS TO BE SCRAPED THROUGH THE BODY OF THE CATHETER. IT WAS ALSO REPORTED THERE WAS A SMALL FILM LOOKING LIKE MATERIAL ON ONE SIDE OF THE SHAFT. THE CATHETER WAS REPLACED, AND THE ISSUE WAS RESOLVED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THERE¿S NO INDICATION THAT INTERNAL COMPONENTS WERE EXPOSED. THERE ARE NO DETAILS ON HOW FAR FROM THE DISTAL TIP WAS THE FOREIGN MATERIAL FOUND. WITH THE INFORMATION AVAILABLE, THIS IS BEING CONSERVATIVELY CODED AND REPORTED AS ¿FOREIGN MATERIAL ON USABLE LENGTH OF CATHETER¿. BENT SHAFT IS NOT MDR-REPORTABLE. FOREIGN MATERIAL IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11476349 ↗
• MalfunctionJul 28, 2020Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT A PATIENT UNDERWENT ATRIAL FLUTTER RIGHT (R-AFL) ABLATION PROCEDURE WITH A WEBSTER ® CS CATHETER WITH EZ STEER® TECHNOLOGY AND AUTO ID WHERE DAMAGED ELECTRODE ISSUE OCCURRED. IT WAS REPORTED THAT THE DISTAL POLE HAD A PARTIAL ELECTRODE. WHEN REMOVING OUT OF THE BODY LOOKS LIKE THE ELECTRODE IS MISSING OR MAY BE BURIED IN THE PLASTIC. THE CABLE WAS REPLACED WITHOUT RESOLUTION. A DIFFERENT PORT WAS ALSO TRIED BUT THE ISSUE PERSISTED. THE WEBSTER ® CS CATHETER WITH EZ STEER® TECHNOLOGY AND AUTO ID WAS REPLACED AND THE ISSUE RESOLVED. THE CASE CONTINUED. THERE WAS NO REPORT OF PATIENT CONSEQUENCE OR EXTENDED HOSPITALIZATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10330811 ↗
• DeathFeb 21, 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 A RIGHT SIDED ATRIAL FLUTTER (R-AFL) ABLATION PROCEDURE WITH A SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER AND A WEBSTER ® CS CATHETER WITH EZ STEER® TECHNOLOGY AND AUTO ID AND SUFFERED CARDIAC ARREST (REQUIRING CARDIOPULMONARY RESUSCITATION (CPR)) AND RESULTED IN DEATH. WHEN THE DIAGNOSTIC PORTION OF THE PROCEDURE WAS COMPLETED (WHILE USING DIAGNOSTIC CATHETERS ONLY), THE PATIENT¿S BLOOD PRESSURE DROPPED DRASTICALLY. THE SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER WAS STILL INSIDE THE PATIENT¿S BODY AND WAS USED TO CHECK FOR AN EFFUSION; HOWEVER, NO EFFUSION WAS CONFIRMED. THE ECHO TEAM WAS CALLED TO THE ROOM TO FURTHER EVALUATE THE POTENTIAL CAUSE OF THE DROP IN THE PATIENT¿S BLOOD PRESSURE. THE PATIENT THEN WENT INTO CARDIAC ARREST. CODE WAS CALLED OVER HOSPITAL INTERCOM, AND CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED. AFTER APPROXIMATELY ONE HOUR, IT WAS ANNOUNCED THAT THE PATIENT HAD EXPIRED. THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PATIENT CONDITION RELATED, SINCE THE PATIENT WAS AN INPATIENT THAT HAD BEEN EXPERIENCING FLUTTER FOR AN EXTENDED PERIOD ALONG WITH OTHER

  Patient problems: Cardiac Arrest; Death

  MAUDE report 9741573 ↗
• DeathJan 27, 2020Adverse 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 IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) WITH A WEBSTER ® CS CATHETER WITH EZ STEER® TECHNOLOGY AND AUTO ID AND SUFFERED CARDIAC TAMPONADE (REQUIRING PERICARDIOCENTESIS) CARDIAC ARREST (REQUIRING CARDIOPULMONARY RESUSCITATION (CPR)) AND DEATH. PATIENT¿S INR WAS 2.2 PRIOR TO THE PROCEDURE AND RECEIVED 2 UNITS OF FRESH FROZEN PLASMA (FFP). THE PATIENT HAD HISTORY OF NON-ISCHEMIC CARDIOMYOPATHY WITH SEVERE MITRAL VALVE REGURGITATE AND AN EJECTION FRACTION OF 20%. THE HEART WAS QUITE ENLARGED, AND THE PATIENT HAD PREVIOUS ABLATION. UPON PLACEMENT OF THE CORONARY SINUS CATHETER, THE PHYSICIAN AND STAFF NOTED AN UNUSUAL DIRECTION TO THE CATHETER BUT THOUGHT IT MAY BE RELATED TO THE PATIENT¿S ANATOMY. THERE WAS NO ERROR OR CONCERN ABOUT THE FUNCTIONALITY OF THE CATHETER BY THE PHYSICIAN. THERE WERE NO ERRORS ON THE CARTO SYSTEM DURING THE CASE. DURING THE CASE, PATIENT WAS NOTED TO HAVE A PERICARDIAL EFFUSION AND CARDIAC TAMPONADE, THIS WAS CONFIRMED BY TRANSTHORACIC ECHOCARDIOGRAM (TTE). PERICARDIOCENTESIS WAS PERFORMED TO RETRIEVE THE FLUID FROM THE PERICARDIAL SPACE; HOWEVER, DUE TO COMBINATION OF PATIENT CONDITION AND COMPLICATI

  Patient problems: Cardiac Arrest; Cardiac Tamponade; Death

  MAUDE report 9635382 ↗
• InjurySep 5, 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 PAROXYSMAL ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A WEBSTER ® CS CATHETER WITH EZ STEER® TECHNOLOGY AND AUTO ID AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND SURGICAL INTERVENTION. POST-ABLATION PHASE, CARDIAC TAMPONADE WAS CONFIRMED BY ECHO AS THE PATIENT¿S BLOOD PRESSURE DROPPED. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE ABOUT 300-400 ML OF FLUID FROM THE PERICARDIAL SPACE. THE PATIENT WAS THEN MOVED TO THE OPERATING ROOM TO CLOSE THE PERFORATION. DURING SURGERY IT WAS FOUND THAT THERE WAS A TEAR IN THE CORONARY SINUS (CS). PATIENT¿S OUTCOME IS IMPROVED, THE PHYSICIAN REPORTED THE PATIENT WAS OUT OF SURGERY AND DOING WELL. IT IS UNKNOWN IF EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED, MOST LIKELY DUE TO EITHER THE CS CATHETER OR THE ABLATION CATHETER (WHICH WAS LOCATED IN THE RIGHT ATRIUM NEAR THE CS) PERFORATING THE CS DURING SEVERAL MULTIPLE CARDIOVERSIONS. NO BWI PRODUCT MALFUNCTIONS WERE REPORTED. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A ST. JUDE MEDICAL BRK-1 XS TRANSSEPTAL

  Patient problems: Cardiac Tamponade; No Code Available

  MAUDE report 8964817 ↗
• MalfunctionMay 16, 2019Contamination /Decontamination Problem; Sharp Edges; Contamination /Decontamination Problem; Sharp Edges

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) PROCEDURE WITH A WEBSTER ® CS CATHETER WITH EZ STEER® THECHNOLOGY AND AUTO ID CATHETER AND IT WAS REPORTED THAT THERE WAS ELECTRODE DAMAGE AND FOREIGN MATERIAL ON THE CATHETER. INITIALLY, IT WAS REPORTED THAT THERE WAS AN ISSUE WITH DEFLECTION AND THAT THE CATHETER WASN'T WORKING PROPERLY. WHEN REMOVED FROM THE BODY THE CATHETER WAS NOTICED TO HAVE AN ELECTRODE THAT WASN'T COMPLETE, THE DISTAL TIP SEEMED TO HAVE A DROP OF GLUE ON THE ELECTRODE, AND THE ELECTRODE DID NOT SEEM TO COME ALL THE WAY TO THE TIP AND SEEMED TO BE EMBEDDED IN THE PLASTIC. THE CATHETER WAS REPLACED, AND THE ISSUE RESOLVED. THERE WAS NO PATIENT CONSEQUENCE. THE DEFLECTION ISSUE WAS ASSESSED AS A NOT REPORTABLE EVENT. THE ISSUE OF ELECTRODE DAMAGED WITH FOREIGN MATERIAL WAS REVIEWED AND ASSESSED A REPORTABLE EVENT. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON MAY 10, 2019 AND IT WAS REPORTED THAT THERE WAS NO VISUAL DAMAGE OR ANOMALIES OBSERVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8617378 ↗
• InjuryJan 28, 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 UNDERWENT AN ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION ON WHICH A WEBSTER ® CS CATHETER WITH EZ STEER® TECHNOLOGY AND AUTO ID WAS USED, AND SUFFERED CARDIAC TAMPONADE (REQUIRING PERICARDIOCENTESIS AND SURGICAL INTERVENTION) AND SEPSIS. DURING THE PROCEDURE, THE PATIENT¿S BLOOD PRESSURE DROPPED. CARDIAC TAMPONADE WAS CONFIRMED BY ECHO. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE AN UNSPECIFIED AMOUNT OF FLUID FROM THE PERICARDIUM. THE PATIENT ALSO REQUIRED A CORONARY SINUS (CS) REPAIR VIA PERICARDIAL WINDOW. PART OF THE DIAPHRAGM HAD TO BE REPLACED AS A RESULT OF THIS AS WELL. EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT. PATIENT¿S CONDITION WORSENED AS IS SUSPECTED OF DEVELOPING SEPSIS. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT THE CS WAS PERFORATED BY THE WEBSTER ® CS CATHETER WITH EZ STEER® TECHNOLOGY AND AUTO ID. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Cardiac Tamponade; No Code Available; Sepsis

  MAUDE report 8282790 ↗
• MalfunctionJan 8, 2018Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT A PATIENT (B)(6) FEMALE PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRY TACHYCARDIA PROCEDURE WITH A WEBSTER ® CS CATHETER WITH EZ STEER® TECHNOLOGY AND AUTO ID AND A NOISE ISSUE OCCURRED. A STRONG NOISE OCCURRED ON ALL ELECTROCARDIOGRAM (ECG) CHANNELS, INCLUDING THE BODY SURFACE AND THE INTRACARDIAC CHANNELS, ON BOTH THE CARTO 3 AND RECORDING SYSTEM. THE PHYSICIAN DID NOT HAVE ANY CLEAR ECG SIGNAL TO MONITOR THE PATIENT¿S HEART RHYTHM. THE CATHETER WAS CHANGED AND THE ISSUE RESOLVED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCE. THIS EVENT IS MDR REPORTABLE BECAUSE LACK OF MONITORING OF CARDIAC RHYTHM WHILE DEVICES ARE INTRACARDIAC MAY POSE A POTENTIAL RISK TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7171643 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K101345. One submission often covers many models, so check the product and lot details in each record.

• Z-1647-2012 · Dec 15, 2007 · Terminated
  EZ STEER Catheter D-1267-04-S / 8mm Non-Navigation Bi-Directional Catheter Cardiovascular catheter for use in electrophysiological diagnosis and ablation.