WEBSTER 1086259RTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10846835001181), received between Jan 17, 2020 and Jan 17, 2020 — 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.

• InjuryJan 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH A WEBSTER¿ ELECTROPHYSIOLOGY CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE WHILE USING AN STSF CATHETER NOISE WAS OBSERVED FROM THE CATHETER ELECTRODES BEING DISPLAYED ON THE CARTO 3 AND ELECTROPHYSIOLOGY RECORDING SYSTEMS. THE CABLE WAS REPLACED, BUT THE ISSUE REMAINED. THE CATHETER WAS THEN EXCHANGED, AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED SUCCESSFULLY. THE CARTO 3 SYSTEM WAS OPERATING PER SPECIFICATIONS AND IS NOT CONSIDERED RESPONSIBLE OF THE ISSUE. THE CATHETER WAS DETERMINED TO BE THE ROOT CAUSE OF THE ISSUE EXPERIENCED. IT WAS ALSO REPORTED THAT PERICARDIAL EFFUSION WAS NOTED AFTER TRANSSEPTAL ACCESS AND AFTER SOME ABLATIONS WERE DONE WITH THE REPLACEMENT STSF CATHETER. THE PATIENT¿S SYSTOLIC BLOOD PRESSURE DROPPED TO 90, AND CARDIAC TAMPONADE WAS CONFIRMED BY ULTRASOUND AND INTRACARDIAC ECHOCARDIOGRAPHY (ICE). PERICARDIOCENTESIS WAS PERFORMED AND A TOTAL OF 330 CC OF FLUID WAS REMOVED FROM THE PERICARDIAL SPACE. THE PROCEDURE CONTINUED AND SOME OTHER ABLATIONS WERE DONE. HOWEVER, THE PROCEDURE WAS UNAB

  Patient problems: Cardiac Tamponade

  MAUDE report 9603669 ↗