Woven M0046FMC007220Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729901600), received between Apr 15, 2021 and Apr 15, 2021 — 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.

• InjuryApr 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER AND AN INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER WERE USED IN A ATRIAL FIBRILLATION ABLATION PROCEDURE. WHEN HEMOSTASIS WAS PERFORMED SLIGHTLY LOW BLOOD PRESSURE WAS NOTED AND PERICARDIAL FLUID WAS SLIGHTLY ACCUMULATED. THIS WAS CONFIRMED WITH ECHOCARDIOGRAPHY. A PERICARDIAL DRAIN WAS PERFORMED. IT WAS NOTED THAT BRADYCARDIA CONTINUED AFTER THE ATRIAL FIBRILLATION WAS STOPPED. THE PATIENT THEN HAD A NON-BOSTON SCIENTIFIC PACEMAKER IMPLANTED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR ANALYSIS. IT WAS FURTHER REPORTED THAT A WOVEN DIAGNOSTIC ELECTRODE CATHETER WAS ALSO USED THE ATRIAL FIBRILLATION ABLATION PROCEDURE.

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 11674858 ↗