Woven M0042005940Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729899501), received between Jan 22, 2019 and Mar 19, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Body Fluid” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2019Device Contamination with Body Fluid; Device Contamination with Body Fluid

  IT WAS REPORTED THAT BODY FLUID INGRESS OCCURRED. AFTER AN ABLATION PROCEDURE WITH A WOVEN DIAGNOSTIC ELECTRODE CATHETER, THE PHYSICIAN CUT THE DEVICE AFTER USAGE TO COLLECT THE ELECTRODE PART AND LEAKAGE OF BLOOD WAS CONFIRMED FROM THE INSIDE OF THE CUT PART. THERE WAS NO PROBLEM WITH REGARDS TO THE USAGE DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE AND THERE WAS NO SERIOUS INJURY OR ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8431814 ↗
• InjuryJan 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERICARDIAL EFFUSION WAS EXPERIENCED. ON (B)(6) 2019, DURING AN ABLATION PROCEDURE FOR ATRIAL FLUTTER AND ATRIAL FIBRILLATION, THE PHYSICIAN MAPPED IN THE RIGHT ATRIUM WITH AN INTELLAMAP ORION CATHETER AND ALSO ABLATED IN SEVERAL AREAS IN THE RIGHT ATRIUM WITH AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER. IT WAS A DIFFICULT TRANSSEPTAL WITH NON-BOSTON SCIENTIFIC DEVICES. DURING TRANSSEPTAL, THE PHYSICIAN NOTICED A DROP IN THE PATIENT'S BLOOD PRESSURE, SO THE PHYSICIAN DID AN ECHOCARDIOGRAM AND OBSERVED AN EFFUSION. SO, HE PUT IN A PERICARDIOCENTESIS CATHETER POST TRANSSEPTAL BEFORE MAPPING ON THE LEFT SIDE, DRAINED FLUID OUT OF THE PERICARDIAL SPACE AND THEN MAPPED AND ABLATED IN THE LEFT ATRIUM. THE EFFUSION CONTINUED DURING MAPPING ABLATION IN THE LEFT ATRIUM. THEY ENDED UP OPENING THE PATIENT'S CHEST AND CLOSING THE AREA THAT CAUSED THE EFFUSION. THE PATIENT WAS DOING WELL AS OF (B)(6) 2019. THE PHYSICIAN WASN'T SURE IF THE EFFUSION HAPPENED IN TRANSSEPTAL. IT WAS REPORTED THAT THE PATIENT HAD A PERSISTENT LEFT SUBCLAVIAN VEIN, AN ABNORMAL STRUCTURAL ASPECT OF THE PATIENT. DURING THE TRANSSEPTAL ACCESS, IT WAS JUST THE TRANSSEPTAL EQUIPMENT AND THE WOVEN DIA

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 8266645 ↗