WEBSTER F6QF005CTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10846835007978), received between Jun 19, 2018 and Jun 19, 2018 — 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.

• InjuryJun 19, 2018Adverse 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 AN IDIOPATHIC VENTRICULAR TACHYCARDIA ABLATION PROCEDURE FOR PREMATURE VENTRICULAR CONTRACTIONS (PVCS) WITH TWO (2) WEBSTER¿ ELECTROPHYSIOLOGY CATHETERS AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. TOWARD THE END OF THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE. PERICARDIAL EFFUSION WAS DETECTED VIA ECHOCARDIOGRAPHY. PERICARDIOCENTESIS YIELDED AN UNSPECIFIED VOLUME OF FLUID. PATIENT REQUIRED EXTENDED HOSPITALIZATION (4 ADDITIONAL NIGHTS) AS A RESULT OF THE ADVERSE EVENT FOR MONITORING. THERE WERE NO PATIENT FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. PATIENT FULLY RECOVERED WITH NO RESIDUAL EFFECTS AND WAS DISCHARGED TO HOME. IT WAS NOTED THAT THE INJURY OCCURRED MID TO POST-ABLATION. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS RELATED TO THE WEBSTER¿ ELECTROPHYSIOLOGY CATHETER. THERE WERE NO ISSUES, ERRORS, OR MALFUNCTIONS REPORTED ON ANY BWI PRODUCTS OR EQUIPMENT DURING THE PROCEDURE. NO TRANSSEPTAL PUNCTURE WAS PERFORMED, AS TRANSSEPTAL ACCESS WAS OBTAINED VIA A PATENT FORAMEN OVALE (PFO). THERE IS NO SHEATH INFORMATION. GENERATOR WAS SET ON POWER CONTROL MO

  Patient problems: Cardiac Tamponade

  MAUDE report 7615702 ↗