WEBSTER F6QF005RTRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10846835000498), received between Sep 5, 2018 and Jul 8, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL RE-ENTRANT TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH A WEBSTER¿ ELECTROPHYSIOLOGY CATHETER AND A KNOTTED CATHETER ISSUE OCCURRED. DURING THE INTRODUCTION OF THE CATHETER INTO THE BODY, THE CATHETER CREATED A KNOT AND WAS NOT ABLE TO MOVE FORWARD OR BACKWARD. A LARGER 16- FRENCH SHEATH WAS INTRODUCED AND THEY WERE ABLE TO CLEAR THE CATHETER FOR RETRIEVAL. THE CATHETER WAS CUT AS A RESULT OF THE RETRIEVAL PROCESS. THERE WAS NO PATIENT HARM AND THE CASE CONTINUED WITH NO OTHER ISSUE. ADDITIONAL INFORMATION: THE DAMAGE DID NOT RESULT IN WIRES BEING EXPOSED. THE DAMAGE DID NOT RESULT IN ANY LIFTED OR SHARP RINGS. THE DOCTOR FELT NO UNUSUAL RESISTANCE, MEANING HE FELT THE TIP OF THE CATHETER GETTING CAUGHT UP ON COROLLARY VEINS AS IT ADVANCED UP THE IVC. THE CATHETER WAS NOT PRE-SHAPED. SHEATH USED WAS AN UNKNOWN 6F. NO DETACHMENT OF ANY COMPONENT. THE LOOP/TIP DID NOT BECOME UNKNOTTED. THE ISSUE DID NOT RESULT IN EXPOSURE OF ANY INTERNAL CATHETER COMPONENTS OR SHARP EDGES. THIS EVENT WAS ASSESSED AS A MDR REPORTABLE KNOTTED CATHETER ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12134865 ↗
• InjurySep 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE PREMATURE VENTRICULAR CONTRACTIONS (PVC) WITH A WEBSTER¿ ELECTROPHYSIOLOGY CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE MAPPING PHASE, THE ANESTHETIST NOTED THAT THE BLOOD PRESSURE WAS GRADUALLY DROPPING. PATIENT STARTED TO BECOME RESTLESS AND EXPRESSED FEELING NAUSEOUS. PATIENT¿S HEART RATE INCREASED. CARDIAC TAMPONADE WAS CONFIRMED BY ECHO. PERICARDIOCENTESIS WAS PERFORMED AND AN UNKNOWN AMOUNT OF FLUID WAS REMOVED. PATIENT¿S HEART RATE AND BLOOD PRESSURE WERE MONITORED THROUGHOUT PROCEDURE VIA EP RECORDING SYSTEM AND ANESTHETIC EQUIPMENT. NO ABLATION WAS PERFORMED. THE PATIENT WAS TRANSFERRED TO CARDIAC CARE UNIT (CCU). EXTENDED HOSPITALIZATION WAS NOT REQUIRED AS A RESULT OF THE ADVERSE EVENT. PATIENT¿S OUTCOME IS IMPROVED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT THE PATIENT HAD SHORT RUNS OF VENTRICULAR TACHYCARDIA (VT) WHICH CHANGES VENTRICULAR CONTRACTION AND POSSIBLY CAUSED THE WEBSTER¿ ELECTROPHYSIOLOGY CATHETER TO PERFORATE THE RIGHT VENTRICLE (RV). RELEVANT PATIENT¿S HISTORY INCLUDES FREQUENT PREMATURE VENTRICULAR CONTRACTIONS. TRANSSEPTA

  Patient problems: Cardiac Tamponade

  MAUDE report 7847174 ↗