Webster CS BD710DF282CTRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10846835002409), received between Aug 2, 2019 and Dec 29, 2025 — classified as 13 injuries, 8 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 (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A WEBSTER CS CATHETER. THERE WERE "FLOATING BLACK PARTICLES" WITHIN THE PACKAGING TOWARDS THE HANDLE OF THE CATHETER. THEY DID NOT USE THE CATHETER FOR THE PROCEDURE AND REPLACED IT WITH A NEW ONE. THERE WAS NO PATIENT CONSEQUENCE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION OF THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23918749 ↗
• InjuryOct 31, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH A WEBSTER CORONARY SINUS (CS) CATHETER, THE PATIENT EXPERIENCED PERICARDIAL EFFUSION TREATED WITH PERICARDIOCENTESIS AND REMOVAL OF 200CCS OF BLOOD. THE PATIENT WAS TRANSFERRED TO INTENSIVE CARE UNIT (ICU) FOR 24 HOURS OBSERVATION. IT WAS REPORTED THAT AFTER MAPPING IN THE RIGHT ATRIUM AND RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) AND GOING RETROGRADE INTO THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT), THEY HAD NOTICED THE PATIENT HAD A PERICARDIAL EFFUSION. NO ABLATION HAD OCCURRED. THEY NOTICED ON THE VIVID IQ ULTRASOUND MACHINE DURING INTRACARDIAC ECHOCARDIOGRAPHY (ICE) MANIPULATION. PERICARDIOCENTESIS WAS PERFORMED AND EXTRACTED 200CC'S OF BLOOD. THE PATIENT HAD DISPLAYED NO SYMPTOMS. THE PATIENT STATUS IS CURRENTLY STABLE AND WILL BE HELD OVERNIGHT IN THE ICU FOR 24-HOUR OBSERVATION AND THE PERICARDIAL EFFUSION IS CLEARED. THE THERMOCOOL SMARTTOUCH SF CATHETER, WEBSTER CS CATHETER, AND REPROCESSED STERILMED SOUNDSTAR® CATHETER WERE THE ONLY BIOSENSE WEBSTER INC. (BWI) PRODUCTS IN THE BODY AT THE TIME OF THE EVENT. THE REPORTER STATED THE ONLY CATHETER AVAILABLE FOR RETURN IS THE REPROCESSED STERILMED SOUNDSTA

  Patient problems: Cardiac Tamponade

  MAUDE report 23438555 ↗
• MalfunctionSep 3, 2025Signal Artifact/Noise; Break; Signal Artifact/Noise; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A WEBSTER CS CATHETER AND OBSERVED AN INSULATION BREAK AT THE TIP OF THE CATHETER AND METAL WIRES WERE EXPOSED. THE DISTAL TWO ELECTRODES OF THE CATHETER APPEARED BLACK ON THE CARTO 3 SYSTEM AND THERE WAS NOISE FROM THOSE ELECTRODES ON BOTH THE CARTO 3 SYSTEM AND THE RECORDING SYSTEM. THE CATHETER WAS REMOVED FROM THE BODY AND THEY NOTICED THAT THERE WAS AN INSULATION BREAK AT THE TIP OF THE CATHETER AND METAL WIRES WERE EXPOSED. THE CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS CONTINUED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE CATHETER WAS BRAND NEW FROM BIOSENSE WEBSTER, INC. BOX PACKAGING. THE DISTAL TWO ELECTRODES OF THE CATHETER APPEARED BLACK ON THE CARTO 3 SYSTEM AND THERE WAS NOISE FROM THOSE ELECTRODES WAS ASSESSED AS NON MDR. THE RISK TO THE PATIENT WAS LOW. THE INSULATION BREAK AT THE TIP OF THE CATHETER AND METAL WIRES WERE EXPOSED ISSUE WAS ASSESSED AS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22955321 ↗
• MalfunctionAug 12, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE WITH A WEBSTER CS CATHETER AND FOREIGN MATERIAL WAS OBSERVED. UNUSUAL PINK COLORED FOREIGN BODY WAS FOUND ON ONE OF THE ELECTRODES OF THE WEBSTER CS CATHETER, POTENTIALLY COMPROMISING THE CATHETER STERILITY AND QUESTIONING THE ORIGIN OF THIS FOREIGN BODY. THE WEBSTER CS WAS NOT INTRODUCED TO THE PATIENT AND IMMEDIATELY REMOVED OFF THE TABLE TO BE REPORTED FOR INVESTIGATION. THE PROCEDURE WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCE. THE FOREIGN BODY WAS NO LONGER FOUND AFTER THE DECONTAMINATION OF THE CATHETER BUT IT IS IMPORTANT TO REPORT IN ORDER TO DOCUMENT AND ENSURE THAT NO FRAGMENTS ARE INTRODUCED TO THE PATIENTS' BLOODSTREAM. NO FRAGMENTS WERE GENERATED. ADDITIONAL INFORMATION WAS RECEIVED. THE CATHETER WAS NOT USED ON THE PATIENT. THE ISSUE WAS NOTICED BEFORE USE. THE CALLER ASKED TO IMMEDIATELY REMOVE IT FROM THE STERILE ZONE AS WAS NOT SURE AT THAT POINT WHETHER THE CATHETER WAS OKAY TO BE USED OR NOT. ALSO DID NOT WANT TO INTRODUCE ANY FOREIGN MATERIAL OF ANY SORT TO THE PATIENT¿S BLOOD, ESPECIALLY WITH DOUBTS ABOUT THE CATHETER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22783498 ↗
• MalfunctionMar 21, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A WEBSTER CS AND INSIDE THE STERILE PACKAGE, WHEN OPENED, THERE WAS FOREIGN MATERIAL PRESENT. THE CATHETER WAS REPLACED, AND THE CASE CONTINUED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE FOREIGN MATERIAL LOOKS LIKE A TINY PIECE OF CARDBOARD OR DUST. IT IS VERY SMALL IN SIZE AND NOT EMBEDDED TO THE DEVICE. THE ISSUE WAS NOTICED BEFORE USE AND THE DEVICE WAS NOT USED ON THE PATIENT. THE PACKAGE IS UNOPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21665363 ↗
• InjuryMar 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH A WEBSTER ® CS CATHETER WITH EZ STEER® THECHNOLOGY AND AUTO ID AND THE PATIENT EXPERIENCED HEART BLOCK THAT REQUIRED PACEMAKER INSERTION. AV (ATRIOVENTRICULAR) HEART BLOCK WAS DISCOVERED ONCE THE AV SEQUENTIAL PACING (PACING VIA CS CATHETER AND THE HIS CATHETER IN THE VENTRICLE) WAS TURNED OFF. THE PATIENT WAS BEING SEQUENTIALLY PACED, AND ON NITRO WHILE PFA (PULSE FIELD ABLATION) LESIONS WERE APPLIED ON THE ANTERIOR WALL OF THE LEFT ATRIUM WHEN THE HEART BLOCK OCCURRED. ISUPREL WAS ADMINISTERED, BUT THE NORMAL SINUS RHYTHM DID NOT RETURN. PATIENT WAS PACED FROM THE CATHETER WHILE A PERMANENT PACEMAKER WAS INSERTED. PATIENT WAS STABLE.

  Patient problems: Heart Block

  MAUDE report 21540041 ↗
• InjuryMay 22, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION PROCEDURE (LEFT AND RIGHT SIDED) WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND A WEBSTER ® CS CATHETER WITH EZ STEER® THECHNOLOGY AND AUTO ID AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS AND A DRAIN. THE PHYSICIAN TOOK A SOUNDSTAR CATHETER TO THE RIGHT SIDE OF THE HEART TO ESTABLISH A BASELINE: NO PERICARDIAL EFFUSION WAS SHOWING AND BOTH THE LEFT AND NON-CORONARY CUSPS HAD CALCIFICATION. THEY MAPPED BOTH RIGHT AND LEFT VENTRICULAR OUTFLOW TRACTS. PHYSICIAN ABLATED 4 AREAS ON THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) SEPTUM: FIRST LESION WAS ONLY FOR 6 SECONDS BECAUSE CATHETER WAS REPOSITIONED, AND THEN 90S, 100S AND 100S LESIONS WITH POWERS RANGING BETWEEN 35W AND 25W. JUST AFTER THE LAST LESION, THE PATIENT'S BLOOD PRESSURE DROPPED AND THE PHYSICIAN OBSERVED A PERICARDIAL EFFUSION FORMING AT THE SILHOUETTE OF THE HEART. PHYSICIAN PERFORMED A PERICARDIOCENTESIS. THE BLOOD WAS EXTRACTED FROM THE PERICARDIUM AND RE-TRANSFUSED THROUGH THE FEMORAL SHEATH INTO THE PATIENT'S BODY UNTIL THE PATIENT WAS STABLE. NO FURTHER INTERVENTION WAS

  Patient problems: Cardiac Tamponade

  MAUDE report 19378794 ↗
• MalfunctionFeb 9, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM AND A WEBSTER ® CS CATHETER WITH EZ STEER® THECHNOLOGY AND AUTO ID. THE TECHNICIAN OBSERVED THAT THE STOP COCK ON THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM WAS BROKEN. IT APPEARED THAT THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM BOX AND PACKAGING POUCH SEAL WERE BOTH PUNCTURED. THE CALLER THEN REPORTED THAT THE STERILITY OF THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM VIZIGO WAS COMPROMISED. THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED. THE CALLER ALSO REPORTED THAT BECAUSE THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM STERILITY WAS COMPROMISED IN THE FIELD, THE STERILITY OF THE WEBSTER ® CS CATHETER WITH EZ STEER® THECHNOLOGY AND AUTO ID WAS ALSO COMPROMISED. THE WEBSTER ® CS CATHETER WITH EZ STEER® THECHNOLOGY AND AUTO ID WAS REPLACED AND THE ISSUE RESOLVED. THE PROCEDURE CONTINUED. ADDITIONAL INFORMATION WAS RECEIVED. THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM SIDE P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18677394 ↗
• InjuryOct 24, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED A PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTIONS (PVC) CARDIAC ABLATION PROCEDURE UTILIZING A WEBSTER ® CS CATHETER WITH EZ STEER® THECHNOLOGY AND AUTO ID AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE AND REQUIRED MEDICAL INTERVENTIONS. IT WAS REPORTED PERICARDIAL EFFUSION WAS NOTICED ONCE THE CATHETERS WERE PULLED OUT OF THE BODY AND CONFIRMED ON A TRANSTHORACIC ECHO. THE PATIENT'S BLOOD PRESSURE DROPPED. THE EFFUSION WAS TREATED BY PERICARDIOCENTESIS WITH 2500CC¿S FLUID WITHDRAWN. PATIENT TRANSPORTED TO THE OPERATING ROOM (OR) FOR OPEN HEART SURGERY BECAUSE THE BLEEDING WOULD NOT STOP AND SUBSEQUENTLY REQUIRED AN EXTENDED HOSPITAL STAY. PHYSICIAN¿S OPINION IS THE ADVERSE EVENT WAS CAUSED BY THE PROCEDURE. WHEN THE PATIENT WENT INTO SURGERY, THEY DISCOVERED THAT THE PERFORATION WAS IN THE CORONARY SINUS. THE CALLER BELIEVED THAT ¿THE PATIENT MUST HAVE HAD A HOLE AND WHEN THEY PULLED THE CATHETER, IT MUST HAVE OPENED UP THAT HOLE AND IT MUST HAVE STARTED TO BLEED." THE CALLER REPORTED THAT THE PHYSICIAN DID NOT BELIEVE THE CATHETER ITSELF CAUSED THE ISSUE. PATIENT FULLY RECOVERED AND HAS BEEN DISCHARGED POST OP SURGICAL CARE. NO TRANSSEPTAL PUNCTURE PERFORME

  Patient problems: Cardiac Perforation

  MAUDE report 18000409 ↗
• InjuryJun 12, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CRYO ABLATION PROCEDURE WITH A CORONARY SINUS (CS) CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. IT WAS REPORTED THAT A PERICARDIAL EFFUSION WAS DISCOVERED DURING A VEIN CRYO ABLATION. THEY REPORTED THAT THE PATIENT'S BLOOD PRESSURE DROPPED. THE PERICARDIAL EFFUSION WAS CONFIRMED WITH ICE (INTRACARDIAC ECHOCARDIOGRAPHY). THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND THAT 340 CCS OF FLUID WERE REMOVED. THE PROCEDURE WAS ABORTED. THEY REPORTED THAT THE ONLY BWI CATHETER INSIDE THE PATIENT AT THE TIME OF THE PERICARDIAL EFFUSION WAS A CS CATHETER. THE CS CATHETER WAS IN THE INFERIOR VENA CAVA WHEN THE INJURY OCCURRED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE CATHETER WAS UNAVAILABLE FOR RETURN. THE ADVERSE EVENT OCCURRED ON (B)(6) 2023, SAME DAY AS IT WAS CALLED IN. ADVERSE EVENT WAS DETECTED DURING MEDTRONIC CRYO-ABLATION. BWI CS CATHETER HAD BEEN IN THE CORONARY SINUS PRIOR TO ABLATION BUT HAD BEEN PULLED OUT OF THE HEART AND INTO THE INFERIOR VENA CAVA FOR THE CRYO-ABLATION. THIS WAS THE ONLY BWI PRODUCT IN THE BODY AT THE TIME. A 2-5-2 PENTARAY HAD BEEN USED PRIOR TO CRYO

  Patient problems: Cardiac Tamponade

  MAUDE report 17108686 ↗
• InjuryMay 17, 2023Entrapment of Device; Patient Device Interaction Problem; Entrapment of Device; Patient Device Interaction Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A WEBSTER ® CS CATHETER WITH EZ STEER® TECHNOLOGY AND AUTO ID AND THE PATIENT EXPERIENCED A SURGICAL INTERVENTION TO RELEASE AN ENTRAPPED DEVICE AND REQUIRED PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT AN AGILIS GUIDING WIRE SEEMS TO BE STUCK ON THE WEBSTER CS CATHETER. IT WAS AN AFIB CASE AND THE INCIDENT HAPPENED IN RIGHT ATRIUM, PRE TRANSSEPTAL. THE PHYSICIAN WAS NOT ABLE TO GET THEM OUT AND THE PATIENT WAS SENT FOR OPEN HEART SURGERY. SURGERY WAS DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS NOT SUCCESSFULLY COMPLETED. THE PATIENT WENT INTO OPEN HEART SURGERY AND STERNOTOMY WAS PROVIDED AS INTERVENTION. RELEVANT TESTS/LABORATORY DATA- ECHO DONE DURING CASE, TURNED OUT CATHETER WAS STUCK IN CHIARI NETWORK. THE CASE WAS CANCELLED. IN PHYSICIAN¿S OPINION, THE DELAY DID NOT CONTRIBUTE TO A DEATH OR A SERIOUS INJURY TO THE PATIENT. CURVE WAS NOT JAMMED. THE KNOB/PISTON WAS ABLE TO BE TURNED AND/OR PUSHED UP AND DOWN. THERE WAS DIFFICULTY IN REMOVING THE CATHETER. THERE WAS NO RING, ELECTRODE OR OTHER PHYSICAL DAMAGE OBSERVED AT THE DISTAL END OF THE CATHETER. THE ADVERSE EVENT OCCURR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16948543 ↗
• MalfunctionMay 19, 2022Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A WEBSTER ® CS CATHETER WITH EZ STEER® TECHNOLOGY AND AUTO ID FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL)IDENTIFIED THE CATHETER TIP TO BE BROKEN. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT AFTER OPENING THE CATHETER IT LOOKS LIKE THE OUTER PORTION IS RUBBED OFF/ AFFECTED. IT WAS DESCRIBED AS THE OUTER BLUE PORTION OF THE CATHETER LOOKED AS IF IT HAD BEEN RUBBING ON SOMETHING AND COMPROMISED THE OUTER LAYER. I DID NOT SEE ANY EXPOSED WIRES. THERE DID NOT APPEAR TO HAVE ANY SHARP EDGES, HOWEVER THE OUTER POTION OF THE CATHETER WAS SHAVED DOWN. THE CATHETER WAS REPLACED AND THE ISSUE RESOLVED. THERE WAS NO PATIENT CONSEQUENCE. THE CUSTOMER REPORTED ISSUE WAS ASSESSED AS NOT MDR REPORTABLE SINCE THE ISSUE OCCURRED OUTSIDE THE PATIENT BODY SO THE RISK TO THE PATIENT FOR SERIOUS INJURY IS LOW. THE MOST LIKELY CONSEQUENCE IS AN INTRAPROCEDURAL DELAY. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. ON 21-APR-2022, THE BWI PAL REVEALED A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT THE TIP WAS RUBBED OFF WITH INTERNAL COMPONENTS EXPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14438709 ↗
• InjuryMar 23, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AN UNKNOWN PATIENT UNDERWENT AN PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION PROCEDURE WITH A WEBSTER ® CS CATHETER WITH EZ STEER® THECHNOLOGY AND AUTO ID. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. AFTER A SUCCESSFUL ABLATION IN THE LEFT VENTRICLE (LV) SUMMIT AREA, THE DOCTOR RETRACTED THE CS CATHETER INTO THE RIGHT ATRIUM (RA). THE CS CATHETER WAS TOO DEEP INTO THE CORONARY SINUS TO BE ABLE TO DETECT VENTRICULAR SIGNAL ON THE DISTAL PORTION OF THE CATHETER AND A COUPLE OF MINUTES AFTER THE DOCTOR RETRACTED THE CS CATHETER IN THE RA, THE PATIENT HAD A SUDDEN PRESSURE DROP. INVESTIGATION WITH AN ULTRASOUND PROBE SHOWED PERICARDIAL EFFUSION. THE BLOOD WAS IMMEDIATELY DRAINED, AND THE BLOOD PRESSURE OF THE PATIENT RETURNED TO STABLE LEVELS. THE DOCTOR THINKS THAT THE CS MIGHT HAVE CREATED THE EFFUSION IN THE PERICARDIUM. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE AS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. THERE WERE PATIENT CONSEQUENCES AS THE PATIENT HAD A PERICARDIAL EFFUSION. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT CONDITION WAS REPORTED AS "FINE". THE EFFUSION IS RESOLVED.

  Patient problems: Cardiac Tamponade

  MAUDE report 13856009 ↗
• InjuryNov 12, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ELECTROPHYSIOLOGY (EP) STUDY WITH TWO (2) WEBSTER¿ ELECTROPHYSIOLOGY CATHETER & TWO (2) WEBSTER ® CS CATHETER WITH EZ STEER® TECHNOLOGY AND AUTO ID AND THE PATIENT EXPERIENCED ATRIOVENTRICULAR (AV) HEART BLOCK REQUIRING PERMANENT PACEMAKER IMPLANTATION. DURING AN EP STUDY, THE PATIENT PRESENTED AV BLOCK OF 1 MINUTE. BACK-UP PACING WITH A CATHETER PLACED IN THE RIGHT VENTRICLE (RV) WAS POSSIBLE. AFTER A WAITING PERIOD UNDER PACING, THE PHYSICIAN TESTED IF THE AV CONDUCTION WAS BACK, BUT IT WAS NOT COMPLETELY. SO CONTINUOUS PACING FROM THE RV CATHETER WAS NECESSARY. THE PATIENT UNDERWENT THEN A CORONAROGRAPHY AND A PACING SONDE (TEMPORARY PACEMAKER) WAS IMPLANTED TO ENSURE BACK-UP PACING IN CASE OF AV BLOCK. THERE IS NO FURTHER INFORMATION ABOUT IF PROLONGED HOSPITALIZATION WAS REQUIRED. THE PHYSICIAN OPINION IS THAT IT IS NOT A COMPLICATION DUE TO THE PROCEDURE, BUT A PRE-EXISTING PATIENT-RELATED PROBLEM. NO ABLATION OR ABLATION CATHETER WAS IN USE AT ANY TIME. BASED ON THE INFORMATION INITIALLY PROVIDED, THIS EVENT WAS ASSESSED AS NOT MDR REPORTABLE BASED ON PHYSICIAN¿S OPINION INDICATING THIS WAS A PATIENT RELATED PRE-EXISTING CONDITION.

  Patient problems: Heart Block

  MAUDE report 12806541 ↗
• InjuryNov 12, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ELECTROPHYSIOLOGY (EP) STUDY WITH TWO (2) WEBSTER¿ ELECTROPHYSIOLOGY CATHETER & TWO (2) WEBSTER ® CS CATHETER WITH EZ STEER® THECHNOLOGY AND AUTO ID AND THE PATIENT EXPERIENCED ATRIOVENTRICULAR (AV) HEART BLOCK REQUIRING PERMANENT PACEMAKER IMPLANTATION. DURING AN EP STUDY, THE PATIENT PRESENTED AV BLOCK OF 1 MINUTE. BACK-UP PACING WITH A CATHETER PLACED IN THE RIGHT VENTRICLE (RV) WAS POSSIBLE. AFTER A WAITING PERIOD UNDER PACING, THE PHYSICIAN TESTED IF THE AV CONDUCTION WAS BACK, BUT IT WAS NOT COMPLETELY. SO CONTINUOUS PACING FROM THE RV CATHETER WAS NECESSARY. THE PATIENT UNDERWENT THEN A CORONAROGRAPHY AND A PACING SONDE (TEMPORARY PACEMAKER) WAS IMPLANTED TO ENSURE BACK-UP PACING IN CASE OF AV BLOCK. THERE IS NO FURTHER INFORMATION ABOUT IF PROLONGED HOSPITALIZATION WAS REQUIRED. THE PHYSICIAN OPINION IS THAT IT IS NOT A COMPLICATION DUE TO THE PROCEDURE, BUT A PRE-EXISTING PATIENT-RELATED PROBLEM. NO ABLATION OR ABLATION CATHETER WAS IN USE AT ANY TIME. BASED ON THE INFORMATION INITIALLY PROVIDED, THIS EVENT WAS ASSESSED AS NOT MDR REPORTABLE BASED ON PHYSICIAN¿S OPINION INDICATING THIS WAS A PATIENT RELATED PRE-EXISTING CONDITION

  Patient problems: Heart Block

  MAUDE report 12806512 ↗
• MalfunctionSep 11, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A WEBSTER ® CS CATHETER WITH EZ STEER® THECHNOLOGY AND AUTO ID, AND A STERILIZATION COMPROMISED ISSUE OCCURRED. THE WEBSTER ® CS CATHETER WITH EZ STEER® THECHNOLOGY AND AUTO WAS NO LONGER STERILE UPON UNPACKING. THE TWO PLASTIC PART USED TO PACKAGE THE CATHETER WHERE NOT PROPERLY JOINED. THUS, AS THE NURSE OPENED THE PACKAGE, THE CATHETER HEAD WAS NO LONGER FIXED, AND TOUCHED A NON-STERILE SURFACE. THE PRODUCT WAS NOT USED ON THE PATIENT. NO CONSEQUENCES FOR THE PATIENT OCCURRED. IT WAS STATED THAT THE PACKAGING WAS DISCARDED AND ONLY THE PRODUCT WAS KEPT. THE ISSUE REPORTED HAS BEEN ASSESSED AS AN MDR REPORTABLE STERILIZATION COMPROMISED ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10519542 ↗
• MalfunctionMay 21, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION (AFIB) WITH A WEBSTER ® CS CATHETER WITH EZ STEER® TECHNOLOGY AND AUTO ID, AND AN OPEN POUCH SEAL ISSUE OCCURRED. IT WAS REPORTED THAT THE WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY WAS NOT COMPLETELY SEALED INSIDE OF THE BOX. WHEN THE CATHETER WAS REMOVED FROM THE BOX TO OPEN THE PACKAGING IS WHEN IT WAS NOTICED TO BE OPEN. THE CATHETER WAS NOT USED ON THE PATIENT. THE CATHETER WAS REPLACED, AND THE ISSUE RESOLVED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED MULTIPLE ATTEMPTS VIA EMAIL WERE MADE TO OBTAIN CLARIFICATION REGARDING THE EVENT WITH NO RESPONSE. THE CLINICIAN THE CONTACTED THE BIOSENSE WEBSTER INC. (BWI) REPRESENTATIVE VIA PHONE CALL ON 04/23/2020, THE BWI REPRESENTATIVE WAS THE ONE WHO OPENED THE CATHETER. THE OUTER PACKAGING WAS INTACT. THE POUCH SEAL WAS COMPLETELY OPENED, AND THE CATHETER WAS OBVIOUSLY NOT STERILE. NO OTHER ABNORMALITIES WERE OBSERVED. THE OBSERVED OPEN POUCH SEAL ISSUE HAS BEEN ASSESSED AS AN MDR REPORTABLE MALFUNCTION. BASED ON THE ADDITIONAL INFORMATION PROVIDED, THE AWARENESS DATE OF THIS EVENT IS BEING CHANGED TO 04/23/2020.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10081202 ↗
• InjuryFeb 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT ATRIAL FIBRILLATION ABLATION WITH WEBSTER ® CS CATHETER WITH EZ STEER® TECHNOLOGY AND AUTO ID AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE ATRIAL FIBRILLATION ABLATION WHILE IN THE RIGHT SUPERIOR VEIN WITH LASER BALLOON TECHNOLOGY, THE PATIENT¿S BLOOD PRESSURE DROPPED. THE ULTRASOUND CONFIRMED THE PATIENT HAD A PERICARDIAL EFFUSION. THE PATIENT HAD A PERICARDIOCENTESIS AND MORE THAN ONE LITER OF FLUID REMOVED FROM THE PATIENT. THE PATIENT REMAINED STABLE DURING THE PROCEDURE. THE CASE WAS CANCELED. THE WEBSTER ® CS CATHETER WITH EZ STEER® TECHNOLOGY AND AUTO ID WAS IN THE BODY AT THE TIME OF THE ADVERSE EVENT. THE PATIENT WAS HOSPITALIZED FOR OBSERVATION AND HAS FULLY RECOVERED. THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THIS ADVERSE EVENT IS THAT IT WAS PROCEDURE RELATED. A TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A ST. JUDE MEDICAL SL SHEATH AND A BAYLIS TRANSSEPTAL NEEDLE. THE EVENT OCCURRED DURING THE ABLATION PHASE. NO ERRORS MESSAGES WERE OBSERVED ON THE BIOSENSE WEBSTER, INC. EQUIPMENT DURING THE PROCEDURE. NO IRRIGATED CATHETER WAS USED. NO BIOSENSE WEBSTER, INC. ABLATION CATHETER WAS USED. THE EVEN

  Patient problems: Cardiac Tamponade

  MAUDE report 9724523 ↗
• InjuryJan 22, 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 FEMALE PATIENT UNDERWENT AN ATRIOVENTRICULAR REENTRANT TACHYCARDIA (AVRT)/ WOLFF-PARKINSON-WHITE SYNDROME (WPW) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND A WEBSTER ® CS CATHETER WITH EZ STEER® TECHNOLOGY AND AUTO ID AND THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. TOWARDS THE END OF THE CASE (POST-ABLATION PHASE), THE PATIENT¿S BLOOD PRESSURE DECLINED WHILE PACING. THE BLOOD PRESSURE RAISED BACK UP TO AN ACCEPTABLE LEVEL AND THE PROCEDURE CONTINUED. POST-TESTING WITH RE-INSERTION OF INTRACARDIAC ECHOCARDIOGRAPHY (ICE), PERICARDIAL EFFUSION WAS DISCOVERED BY ULTRASOUND ICE. CARDIAC TAMPONADE WAS CONFIRMED BY ICE AND TRANSTHORACIC ECHO (TTE). PERICARDIOCENTESIS WAS PERFORMED AND 320ML OF FLUID WAS REMOVED FROM THE PERICARDIAL SPACE. THE PATIENT STAYED OVERNIGHT FOR MONITORING. PATIENT CONDITION IMPROVED, THE PHYSICIAN SAID THE PATIENT REMAINED STABLE. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED, HE BELIEVED THE EVENT OCCURRED DURING THE MANIPULATION OF RIGHT VENTRICLE (RV) OR THE CORONARY SINUS (CS) CATHETERS POST-ABLATION

  Patient problems: Cardiac Tamponade

  MAUDE report 9618333 ↗
• InjuryNov 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A WEBSTER ® CS CATHETER WITH EZ STEER® THECHNOLOGY AND AUTO ID AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. AFTER THE TRANSSEPTAL PUNCTURE, PRIOR TO ABLATION, THE PATIENT HAD A DROP-IN BLOOD PRESSURE. A SMALL EFFUSION WAS THEN CONFIRMED USING INTRACARDIAC ECHOCARDIOGRAM. NEOSYNEPHRINE AND FLUID WAS ADMINISTERED, AND THE PATIENT'S PRESSURE STABILIZED. THE PATIENT WAS THEN AWAKENED FROM ANESTHESIA. NO FURTHER INTERVENTION WAS PERFORMED, AND PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. THE PHYSICIAN BELIEVES THE EFFUSION WAS A RESULT OF DIFFICULT CORONARY SINUS (CS) CANNULATION, DUE TO ABNORMAL PATIENT ANATOMY. THE PHYSICIAN SPENT A CONSIDERABLE AMOUNT OF TIME TRYING TO PLACE IN THE CS. PHYSICIAN REPORTED THAT THE TRANSSEPTAL SEEMED STRAIGHT FORWARD. THE PHYSICIAN DID NOT INDICATE ANY BIOSENSE WEBSTER INC. PRODUCTS CONTRIBUTING TO THE EVENT. A BASELINE ECHO WAS NOT PERFORMED. THEREFORE, IT IS UNKNOWN IF THE EFFUSION WAS PRESENT PRE-PROCEDURE. NO ABLATION WAS PERFORMED.

  Patient problems: Cardiac Tamponade

  MAUDE report 9342712 ↗
• InjuryAug 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use 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 SUFFERED POSSIBLE MYOCARDIAL INFRACTION (MI) REQUIRING SURGICAL INTERVENTION. DURING THE PROCEDURE, MYOCARDIAL INFRACTION WAS DISCOVERED BY THE ANESTHESIA VITALS. THE CALLER REPORTED THAT THE MI HAS NOT BEEN CONFIRMED YET. THE MEDICAL INTERVENTION PROVIDED WAS A BALLOON PUMP AND A CARDIAC CATHETERIZATION. AFTER CARDIAC CATHETERIZATION, THE RESULT WAS NEGATIVE. THE PATIENT WAS REPORTED IN STABLE CONDITION. THE PROCEDURE WENT FORWARD AS SCHEDULED. IT IS SUSPECTED THAT PATIENT HAD CORONARY EVENT AT BEGINNING OF PROCEDURE THAT THEN RESOLVED. ABLATION WAS NOT PERFORMED DURING THE CASE. NO ISSUES WERE ATTRIBUTED TO EQUIPMENT OR PROCEDURE. THE PROCEDURE WAS COMPLETED AS IT WAS ORIGINALLY INTENDED. THERE¿S NO INFORMATION REGARDING EXTENDED HOSPITALIZATION OR PHYSICIAN CAUSALITY OPINION.

  Patient problems: Myocardial Infarction; No Code Available

  MAUDE report 8857917 ↗

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.