Skip to content

Woven M0042014010Recalls & reported problems

Boston Scientific Corporation · Diagnostic Electrode Catheter · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729899693), received between Aug 20, 2021 and Aug 20, 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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Cardiac Tamponade1
  • Pericardial Effusion1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    DURING AN PACING AND MAPPING PROCEDURE FOR PREMATURE VENTRICULAR CONTRACTIONS A INTELLANAV MIFI OPEN-IRRIGATION CATHETER AND A WOVEN DIAGNOSTIC CATHETER WERE SELECTED FOR USE. IT WAS REPORTED THAT EPICARDIAL EFFUSION AND CARDIAC TAMPONADE WERE OBSERVED VIA INTRACARDIAC ECHOCARDIOGRAPHY. TAMPONADE WAS FURTHER CONFIRMED BY ULTRASOUND IMAGING. IT WAS UNCLEAR WHICH DEVICE CAUSED THE OBSERVED EVENT. THE PHYSICIAN COMMENTED THAT AN INTELLAMAP ORION CATHETER ALSO USED IN THE PROCEDURE DID NOT CONTRIBUTE TO THE EFFUSION OR TAMPONADE. NO RESISTANCE WERE FELT WHILE MANEUVERING THE CATHETERS. PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT HAS RECOVERED AND BEEN DISCHARGED FROM THE HOSPITAL.

    Patient problems: Cardiac Tamponade; Pericardial Effusion

    MAUDE report 12348861 ↗

Other CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING devices

All CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.