WEBSTER D6DR005RTRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10846835000245), received between Apr 25, 2018 and Aug 14, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT IDVT (IDIOPATHIC VENTRICULAR TACHYCARDIA) ABLATION THAT INCLUDED WEBSTER¿ ELECTROPHYSIOLOGY CATHETER. THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. TIMING OF ADVERSE EVENT: DURING USE OF BWI PRODUCTS, DURING MAPPING PHASE DESCRIPTION OF HEALTH HAZARD: IT WAS REPORTED THAT THE PATIENT SUFFERED A PERICARDIAL EFFUSION. THERE WAS A WEBSTER QUAD IN THE RV APEX. THE PATIENT'S BLOOD PRESSURE DROPPED. THE MEDICAL TEAM WAS NOT ABLE TO VISUALIZE THE PERICARDIAL EFFUSION TO CONFIRM THE EFFUSION. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED AND A PERICARDIOCENTESIS WAS PERFORMED. AN UNKNOWN AMOUNT OF FLUID WAS REMOVED. THE MEDICAL TEAM DID NOT HAVE ANY ADDITIONAL INFORMATION ABOUT THE IMMEDIATE INTERVENTION AS THEY "STEPPED OUT OF THE ROOM". APPROXIMATELY HALF AN HOUR TO AN HOUR LATER, THEY PUT THE SOUNDSTAR CATHETER IN AND CONFIRMED THAT THERE WAS NO LONGER AN EFFUSION. THE DRAINAGE TUBE WAS LEFT IN PLACE, FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS CONTINUED AND COMPLETED SUCCESSFULLY. THE PHYSICIAN BELIEVED THAT WHEN PACING FROM THE QUAD ALONG WITH EPINEPHRINE IT MAY HAVE CAUSED THE RIGHT VENTRICLE (RV)

  Patient problems: Cardiac Tamponade

  MAUDE report 17538659 ↗
• MalfunctionJan 3, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A WEBSTER¿ ELECTROPHYSIOLOGY CATHETER AND A BROKEN TIP ISSUE OCCURRED. WHEN THE CATHETER WAS OPENED THE DOCTOR CHECKED IT AND SAW THE POINT WAS FRACTURED, THEREFORE, IT WAS CHANGED IT FOR A NEW ONE. SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. IT IS UNKNOWN IF PROCEDURE WAS SUCCESSFULLY COMPLETED AND IF FRAGMENTS WERE GENERATED. THERE WERE NO PATIENT CONSEQUENCES. THE BROKEN TIP ISSUE IS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16084648 ↗
• InjuryApr 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR VENTRICULAR TACHYCARDIA (VT) WITH A WEBSTER¿ ELECTROPHYSIOLOGY CATHETER AND SUFFERED CARDIAC ARREST REQUIRING DEFIBRILLATION AND CARDIOPULMONARY RESUSCITATION (CPR). CATHETERS WERE PLACED, SOUNDSTAR CATHETER WAS POSITIONED IN THE RIGHT VENTRICLE AND SOUNDMAP OF THE LEFT VENTRICLE WAS COMPLETED. TRANSSEPTAL PUNCTURE WAS THEN PERFORMED. SMARTTOUCH SF WAS POSITIONED IN THE LEFT VENTRICLE AND PACING MANEUVERS WERE PERFORMED FROM THE RIGHT VENTRICULAR APEX (RVA) QUAD CATHETER IN AN ATTEMPT TO INDUCE THE CLINICAL VT. MULTIPLE RUNS OF VT WERE INDUCED, OF WHICH AT LEAST 2 WERE SHOCKABLE. PATIENT WAS DEFIBRILLATED AND WENT INTO PULSELESS ELECTRICAL ACTIVITY (PEA) AND CPR WAS SUCCESSFULLY PERFORMED. REMAINDER OF PROCEDURE WAS ABORTED. NO ABLATION WAS PERFORMED. PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) FOR OBSERVATION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Cardiac Arrest

  MAUDE report 7463148 ↗