NaviStar DS NS7TCJ8L174HSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10846835000627), received between Sep 21, 2016 and Jul 24, 2023 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Bent” (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 18, 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.

• DeathJul 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER RIGHT (R-AFL) ABLATION PROCEDURE WITH A NAVISTAR¿ DS ELECTROPHYSIOLOGY CATHETER. THE PATIENT SUFFERED CARDIAC ARREST AND ULTIMATELY PASSED AWAY. IT WAS REPORTED THAT AN ADVERSE EVENT AND DEATH OCCURRED DURING A CASE. THEY REPORTED THAT DURING AN ATRIAL FLUTTER CASE, AS THEY WERE GAINING ACCESS, THE SEDATED PATIENT'S BLOOD PRESSURE DROPPED INTO THE 70S AND THEIR OXYGEN SATURATION DROPPED DOWN INTO THE 80S BEFORE ANY BIOSENSE WEBSTER PRODUCT WAS USED. THEY REPORTED THAT THEY WERE ORIGINALLY USING MAC ANESTHESIA AND THEN THEY SWITCHED TO GENERAL ANESTHESIA. THE BLOOD PRESSURE REMAINED LOW BUT STABLE. THE ANESTHESIOLOGIST THEN INTUBATED THE PATIENT. THEY REPORTED THAT THEY THEN USED A CORONARY SINUS CATHETER FROM A DIFFERENT COMPANY AND USED OUR NAVISTAR¿ DS ELECTROPHYSIOLOGY CATHETER. THEY THEN BEGAN MAPPING THE TACHYCARDIA AND THEN ABLATED THE TACHYCARDIA. THEY REPORTED THAT NO STEAM POPS OR IMPEDANCE SPIKES WERE NOTED. AFTER ABLATION WAS COMPLETED AND THE BI-DIRECTIONAL ISTHMUS BLOCK WAS ATTAINED, THE PATIENT THEN DISPLAYED PULSELESS ELECTRICAL ACTIVITY AND NO BLOOD PRESSURE READING. THEY PERFORMED A TRANSTHORACIC ECHOCARDIO

  Patient problems: Cardiac Arrest

  MAUDE report 17379953 ↗
• MalfunctionSep 21, 2016Bent; Device Inoperable; Scratched Material

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A NAVISTAR DS ELECTROPHYSIOLOGY CATHETER AND A MAGNETIC SENSOR ERROR DISPLAYED. THE CATHETER WAS CHANGED AND THE ISSUE RESOLVED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCE. THE INCIDENCE OF MAGNETIC SENSOR ERROR IS EASY DETECTABLE BY THE USER. THE CATHETER IS INOPERABLE, SINCE IT CANNOT BE VISUALIZED ON THE CARTO SYSTEM. THE USER WILL HAVE TO REPLACE THE CATHETER. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS DETERIORATION IN STATE OF HEALTH IS REMOTE. THE DEVICE WAS RETURNED TO THE BIOSENSE WEBSTER FAILURE ANALYSIS LAB AND ON (B)(6) 2016 IT WAS DISCOVERED THAT THE PEEK HOUSING WAS BENT AND BROKEN OPEN ON THE PROXIMAL SIDE OF RING #1, LEAVING INTERNAL WIRING EXPOSED. IN ADDITION, THE POLYURETHANE PU MARGIN ALSO PEELING. THIS FINDING HAS BEEN REASSESSED AS MDR REPORTABLE BECAUSE IF THE PEEK HOUSING IS ALMOST SPLITTING, DETACHING, OR INTERNAL PARTS ARE EXPOSED, THEN THE RISK TO THE PATIENT IS CRITICAL DUE TO THE POTENTIAL OF THROMBUS FORMATION FROM EXPOSURE OF INTERNAL PARTS OF THE CATHETER. IN ADDITION, IF THE PU BORDER IS DAMAGED, THEN THERE IS POTENTIAL RISK TO THE PATIENT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5967312 ↗