WEBSTER F6QD005RTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10846835007923), received between Feb 14, 2019 and Feb 14, 2019 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 14, 2019Adverse 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 A PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION PROCEDURE WITH A WEBSTER¿ ELECTROPHYSIOLOGY CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. POST-PROCEDURE, WHILE THE PATIENT WAS IN RECOVERY, BLOOD PRESSURE DROPPED. CARDIAC TAMPONADE WAS CONFIRMED BY ECHOCARDIOGRAM. THE PATIENT WAS MOVED BACK TO THE LAB. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE AN UNSPECIFIED AMOUNT OF FLUID FROM THE PERICARDIUM. AFTER PERICARDIAL PUNCTURE, THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND WAS TRANSFERRED TO INTENSIVE CARE UNIT (ICU) FOR OBSERVATION PURPOSES. PATIENT¿S OUTCOME WAS RECOVERED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED AND CAUSED BY THE WEBSTER¿ ELECTROPHYSIOLOGY CATHETER. PHYSICIAN SUSPECTS THAT THE WEBSTER¿ ELECTROPHYSIOLOGY CATHETER PERFORATED THE RIGHT VENTRICLE (RV) WALL AND TAMPONADE OCCURRED AFTER THE CATHETER WAS REMOVED FROM THE BODY. NO ERROR MESSAGES WERE OBSERVED ON ANY BIOSENSE WEBSTER INC. (BWI) EQUIPMENT DURING THE PROCEDURE. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A COOK TRANSSEPTAL NEEDLE. THE GENERATOR WAS IN POWER CONTROL MODE. TH

  Patient problems: Cardiac Tamponade

  MAUDE report 8340655 ↗