WEBSTER CS D135303Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10846835009972), received between Jan 9, 2019 and Jun 26, 2024 — classified as 2 deaths, 6 injuries, 3 malfunctions.

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

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• DeathJun 26, 2024Adverse 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 ABLATION AND THE PATIENT DIED. AFTER A PULMONARY VEIN ISOLATION (PVI) ON THE (B)(6), THE PATIENT LEFT FINE. THE NEXT DAY, AT 2PM THE PATIENT DIED. AT THE TIME OF REPORTING, THE CAUSE OF DEATH IS UNKNOWN AND AN AUTOPSY WAS ONGOING. IT HAS BEEN MENTIONED THAT THE ABLATION WAS DONE WITH A FARAPULSE AND DRIVE CATHETERS, AND A WEBSTER CORONARY SINUS (CS) CATHETER. SINCE THE CAUSE OF DEATH IS UNKNOWN AND DETAILS ABOUT THE PROCEDURE IS VERY LIMITED, WE CANNOT EXCLUDE BIOSENSE WEBSTER INC. (BWI) CATHETER AS A CONTRIBUTING FACTOR. ADDITIONAL INFORMATION IS BEING REQUESTED FOR CLARIFICATION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19621260 ↗
• InjuryFeb 22, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH A WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY AND THE PATIENT EXPERIENCED CARDIAC PERFORATION THAT REQUIRED PERICARDIOCENTESIS. IT WAS REPORTED THAT THE PATIENT SUFFERED CARDIAC PERFORATION AND PERICARDIAL EFFUSION. NO ABLATIONS HAD BEEN PERFORMED. AFTER FAST ANATOMICAL MAPPING (FAM) WITH THE ABLATION CATHETER IN THE RIGHT ATRIUM AND AFTER TRANSSEPTAL ACCESS, THE EFFUSION WAS NOTICED WHILE PLACING THE WEBSTER CS CATHETER. THE MEDICAL TEAM WAS UNSURE WHEN THE PERFORATION OCCURRED/EFFUSION DEVELOPED, BUT THE PHYSICIAN INDICATED IT MAY HAVE BEEN WHEN THE BAYLIS VERSA CROSS TRANSSEPTAL WIRE WAS IN THE RIGHT ATRIUM. THE EFFUSION COULD HAVE BEEN PRESENT BEFORE THIS. THERE WAS A SUBSTANTIAL AMOUNT OF FLUID NOTICED IN THE PERICARDIUM WITH THE INTRACARDIAC ECHO CATHETER. THE PATIENT'S BLOOD PRESSURE DECREASED TO 55 SYSTOLIC. A PERICARDIOCENTESIS WAS PERFORMED REMOVING ONE LITER OF FLUID. THE PATIENT STABILIZED AND WAS TRANSFERRED TO THE ICU FOR RECOVERY AND OBSERVATION.

  Patient problems: Cardiac Perforation

  MAUDE report 18759131 ↗
• MalfunctionNov 15, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY AND A ODD SILICONE/PLASTIC ATTACHMENT AT THE TIP OF THE CATHETER WAS FOUND. IT WAS REPORTED THEY WERE STRUGGLING TO ADVANCE WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY AND UPON PULLING IT OUT, THEY NOTICED AN ODD SILICONE/PLASTIC ATTACHMENT AT THE TIP OF THE CATHETER. THERE WAS NO PATIENT CONSEQUENCE. 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 18145335 ↗
• MalfunctionJun 6, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT AN UNKNOWN PATIENT UNDERWENT AN UNKNOWN ABLATION PROCEDURE WITH A WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY. THERE WAS AN OVERHANG AT THE DISTAL TIP OF THE CATHETER THAT WAS PRESUMABLY SHAFT MATERIAL. PLACEMENT OF THE CS CATHETER WAS NOT POSSIBLE. WHEN THE CATHETER WAS REMOVED FROM THE PATIENT, AN OVERHANG AT THE DISTAL TIP OF THE CATHETER, PROBABLY DUE TO PRODUCTION, WAS OBSERVED. THIS IS PRESUMABLY SHAFT MATERIAL. THERE WAS NO PATIENT CONSEQUENCES. THE DAMAGE DID NOT RESULT IN WIRES BEING EXPOSED OR ANY LIFTED OR SHARP RINGS. THERE WAS DIFFICULTY DURING INSERTION BECAUSE THE CS-CATHETER COULD NOT BE PLACED IN THE CS. THE ISSUE WAS FOUND DIRECTLY AT THE DISTAL END. DURING THE MANUFACTURING PROCESS, THE ELECTRODES OF THE CATHETER ARE PRESUMABLY EMBEDDED IN THE SHAFT MATERIAL. THIS MUST HAVE RESULTED IN A MATERIAL OVERHANG AT THE DISTAL ELECTRODE OF THE CATHETER. THE RUBBER OVERHANG COVERED THE ENTIRE DISTAL ELECTRODE AND HUNG OVER IT (APPROX. 5MM). THE TIP OR ANY OTHER COMPONENTS WERE NOT DETACHED FROM THE DEVICE. NO PATIENT CONSEQUENCES WERE REPORTED. CATHETER SHAFT DETACHMENT/BREAKAGE INSIDE THE PATIENT IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14606274 ↗
• MalfunctionApr 22, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT AN UNKNOWN PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY. THE CATHETER HAD FOREIGN MATERIAL ON THE CATHETER. THE CS CATHETER HAD YELLOW TAPE STUCK TO THE END OF THE CATHETER AND THE STAFF DIDN'T WANT TO USE IT BECAUSE THEY FELT THAT IT WOULD GET STUCK WHEN INSERTED INTO THE SHEATH. WHEN THE CATHETER WAS REPLACED, THE ISSUE RESOLVED. IT WAS SHIPPED WITH THE ORANGE TAPE NOT THE NORMAL BLUE TAPE. THERE WERE NO WIRES AND/OR BRAID BEING EXPOSED AND NO LIFTED OR SHARP RINGS. THE CATHETER WAS NEVER INSERTED IN THE PATIENT. THERE WAS NO DETACHMENT. THE CATHETER FELT DIFFERENT WHERE THE TAPE PLACED ONTO. THE SHAFT ¿ HANDLE TRANSITION IS WHERE THE CATHETER DIFFERS FROM PAST CS CATHETERS. FOREIGN MATERIAL ON USABLE LENGTH OF CATHETER IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14189325 ↗
• InjuryMar 19, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT A VENTRICULAR TACHYCARDIA (VT) ABLATION PROCEDURE WITH A WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY AND SUFFERED VENTRICULAR FIBRILLATION REQUIRING SURGICAL INTERVENTION. IT WAS REPORTED THAT AT A VT PROCEDURE, VT PERSISTED (HEMODYNAMICS DID NOT STABILIZE), SO BURST PACING WAS PERFORMED THROUGH A CATHETER PLACED IN THE HEART, BUT THE VT DID NOT STOP. THE VT SHIFTED TO VENTRICULAR FIBRILLATION (VF), AND IT WAS STOPPED BY EXTERNAL CARDIOVERSION, BUT BLOOD PRESSURE DID NOT INCREASE. FINALLY, AN IMPELLA DEVICE, A PUMP CATHETER FOR AUXILIARY CIRCULATION WAS PLACED INTRACARDIALLY TO STABILIZE HEMODYNAMICS. THE PROCEDURE WAS THEN COMPLETED. ACCORDING TO THE PHYSICIAN'S COMMENT, THE PATIENT HAD A BACKGROUND THAT ¿THE ORIGINAL CARDIAC FUNCTION WAS NOT GOOD.¿ ABLATION WAS NOT DONE, SO THERE WAS NO CAUSAL RELATIONSHIP WITH THE PRODUCT. THE PROCEDURE CAUSED MASSIVE BLEEDING AND THE PRODUCT COULD NOT BE COLLECTED. THE COMPLAINT PRODUCT WILL NOT BE RETURNED FOR ANALYSIS. THE SOUNDSTAR ECO CATHETER LOT NUMBER IS E8350469. THIS ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EV

  Patient problems: Heart Block; Hemorrhage/Blood Loss/Bleeding; Ventricular Fibrillation

  MAUDE report 13817616 ↗
• InjuryApr 26, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT SURGERY FOR CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) IMPLANTATION ON WHICH A WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY WAS USED AND THE PATIENT SUFFERED PERFORATION IN THE CORONARY SINUS (CS) REQUIRING NO INTERVENTION. DURING THE PREPARATION FOR THE PROCEDURE TO PLACE THE LEFT VENTRICULAR LEAD IN THE CS, A WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY WAS PLACED IN THE CS. NO CHANGES TO THE PATIENT¿S BLOOD PRESSURE NOR PERICARDIAL EFFUSION WERE NOTED ON ECHOCARDIOGRAPHY. THE PHYSICIAN THEN PLACED THE CRT-P BUT A PERFORATION IN THE CS WAS CONFIRMED. THE DEVICE WAS REMOVED FROM THE PATIENT AND WAS DISCARDED. THE PATIENT IS SCHEDULED TO BE IMPLANTED WITH AN IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD). THE REMAINDER OF THE PROCEDURE WAS DISCONTINUED. NO MEDICAL/SURGICAL INTERVENTION WAS PROVIDED. PROLONGED HOSPITALIZATION WAS NOT REQUIRED. THE PHYSICIAN IS UNSURE ON WHAT DEVICE CAUSED THE PERFORATION. NO BIOSENSE WEBSTER INC.(BWI) PRODUCT MALFUNCTIONS WERE REPORTED. WITH THE INFORMATION AVAILABLE, GIVEN THAT THE WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY WAS PLACED IN THE CORONARY SINUS AND THE PHYSICIAN IS UNSURE ON WHAT PRODUCT CA

  Patient problems: Cardiac Perforation; Perforation of Vessels

  MAUDE report 11726368 ↗
• InjuryJan 13, 2021Entrapment of Device; Patient Device Interaction Problem; Entrapment of Device; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT CARDIAC ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION WITH A WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY WHERE DEVICE ENTRAPMENT OCCURRED. IT WAS REPORTED THAT THE WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY BECAME ENTRAPPED IN THE PATIENT'S CORONARY SINUS OSTEUM AND COULD NOT BE EASILY REMOVED. THE CARDIOTHORACIC SURGEON WAS SPEAKING TO THE PATIENT AT THE TIME OF THE CALL AND THAT THEY WILL LIKELY BE SENT TO SURGERY FOR REMOVAL. THE PATIENT WAS STABLE, AND NO INJURY WAS REPORTED AT THE TIME OF THE CALL. THERE IS NO INFORMATION ABOUT THE HOSPITALIZATION. THE REPORTED DEVICE ENTRAPMENT WAS ASSESSED AS A MDR REPORTABLE MALFUNCTION. ALTHOUGH THERE¿S NO CONFIRMATION THAT SURGICAL INTERVENTION WAS PERFORMED, WITH THE INFORMATION AVAILABLE, IT IS MOST LIKELY THAT THE PATIENT HAD TO UNDERGO SURGERY TO HAVE THE CATHETER REMOVED FROM ITS BODY; THEREFORE, SURGICAL INTERVENTION WAS ASSESSED AS A PATIENT CONSEQUENCE. SINCE SURGICAL INTERVENTION WAS REQUIRED TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE OF A BODY STRUCTURE, THEN THE EVENT WAS TO BE CONSIDERED SERIOUS AND MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11166218 ↗
• InjuryMay 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CRYO ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE AND A CARDIAC TAMPONADE WAS CONFIRMED BY TRANSTHORACIC ESOPHAGEAL ECHO (TEE). A PERICARDIOCENTESIS WAS PERFORMED TO REMOVE AN UNSPECIFIED AMOUNT OF FLUID FROM THE PERICARDIAL SPACE. THE PATIENT WAS REPORTED IN STABLE CONDITION AFTER PERICARDIAL DRAINAGE. IT IS UNKNOWN IF EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT. PATIENT RECOVERED. THE PHYSICIAN DID NOT ATTRIBUTE THE CAUSALITY OF THE ADVERSE EVENT TO THE BIOSENSE WEBSTER, INC. (BWI) PRODUCT BUT TO CRYO. THE ONLY BWI CATHETER THAT WAS IN USE AT THE TIME OF THE INJURY WAS THE WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY. NO RADIO FREQUENCY DELIVERY WAS APPLIED WITH ANY BWI PRODUCT DURING THE PROCEDURE. NO VISITAGS WERE USED. INITIALLY, SINCE THE PHYSICIAN ATTRIBUTED THE CAUSALITY OF THE EVENT TO CRYO (NON-BWI PRODUCT) AND NO BWI ABLATION CATHETER WAS USED DURING THE PROCEDURE, THE WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY WAS ASSESSED AS A CONCOMITANT PRO

  Patient problems: Cardiac Tamponade

  MAUDE report 10058168 ↗
• DeathJun 5, 2019Adverse 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 AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY AND SUFFERED CARDIAC TAMPONADE (REQUIRING PERICARDIOCENTESIS AND SURGICAL INTERVENTION) AND DEATH. AFTER FEMORAL VEIN PUNCTURE, THE SOUNDSTAR ECO 8FG ULTRASOUND CATHETER WAS INSERTED INTO THE PATIENT¿S BODY AND SEVERAL CONTOURS OF THE LEFT ATRIUM AND RIGHT ATRIUM WERE ACQUIRED. AFTER THAT, TRANSSEPTAL PUNCTURE WAS PERFORMED, AND THE WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY WAS INSERTED. AT THAT TIME DURING THE ABLATION PHASE, THE PATIENT BECAME HYPOTENSIVE, AND CARDIAC TAMPONADE WAS CONFIRMED. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE AN UNSPECIFIED AMOUNT OF ARTERIAL BLOOD FROM THE PERICARDIAL SPACE; HOWEVER, THE BLEEDING COULD NOT BE STOPPED, AND THORACOTOMY WAS PERFORMED. THE PATIENT APPEARED TO BE IN STABLE CONDITION; HOWEVER, THE PATIENT DIED AFTER THEY WERE TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE DEATH IS THAT IT OCCURRED DUE TO THE CARDIAC TAMPONADE THAT OCCURRED BY INJURY TO THE LEFT ATRIUM DURING TRANSSEPTAL PUNCTURE AND THAT THERE¿S NO RELATIONSHIP BETWEEN

  Patient problems: Cardiac Tamponade; Death; No Code Available

  MAUDE report 8672344 ↗
• InjuryJan 9, 2019Adverse 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 WITH A WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, THE PATIENT¿S BLOOD PRESSURE DROPPED. THE PHYSICIAN WAS NOT MADE AWARE OF THIS UNTIL 20 MINUTES LATER. PERICARDIOCENTESIS WAS PERFORMED AND 400 CC OF FLUID WERE REMOVED FROM THE PERICARDIAL SPACE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AFTER PERICARDIAL DRAINAGE. THERE¿S NO INFORMATION REGARDING EXTENDED HOSPITALIZATION OR PATIENT¿S OUTCOME. PHYSICIAN BELIEVED THE INJURY MAY HAVE BEEN THE RESULT OF THE WEBSTER CS CATHETER HAVING FALLEN OUT OF THE CORONARY SINUS AND POSITIONED HALF IN THE RIGHT ATRIUM AND HALF RIGHT VENTRICLE, CAUSING A PERFORATION LEADING TO THE EFFUSION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Cardiac Tamponade

  MAUDE report 8232566 ↗