Woven M004200066S0Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729898825), received between Jun 3, 2022 and Jun 3, 2022 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN PROCEDURE USING AN WOVEN DIAGNOSTIC ELECTRODE CATHETER THE PATIENT EXPERIENCED PERICARDIAL EFFUSION. THE PHYSICIAN SUSPECTED THE CAUSE WAS THE DIAGNOSTIC CATHETER PUNCTURING THE RIGHT VENTRICULAR APEX. THE DAMAGE MOST LIKELY OCCURRED PRIOR TO THE ABLATION PART OF THE PROCEDURE. NO INTERVENTIONS WERE PERFORMED FOR THE PERICARDIAL EFFUSION OR THE PUNCTURE. THE PROCEDURE HAD BEEN COMPLETED BY THE TIME OF DISCOVERY AND THE PATIENT IS EXPECTED TO MAKE A FULL RECOVERY. THE CATHETER IS NOT EXPECTED TO BE RETURNED AS IT WAS DISPOSED OF BY THE SITE.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 14594700 ↗