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WEBSTER 1085122RTRecalls & reported problems

Biosense Webster Inc · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10846835000177), received between Apr 8, 2022 and Apr 8, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Entrapment of Device” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Entrapment of Device1
  • Material Twisted/Bent1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionApr 8, 2022Entrapment of Device; Material Twisted/Bent; Entrapment of Device; Material Twisted/Bent

    IT WAS THAT AN UNKNOWN PATIENT UNDERWENT AN ATRIAL FLUTTER RIGHT (R-AFL) ABLATION PROCEDURE WITH A WEBSTER¿ ELECTROPHYSIOLOGY CATHETER. DURING INSERTION OF THE CATHETER THE CATHETER WAS TWISTED AND DAMAGED. THE CATHETER WAS DIFFICULT TO REMOVE AND THE DOCTOR HAD TO DO SEVERAL MANEUVERS TO REMOVE IT. THE DOCTOR WAS RAISING THE CATHETER INTO THE PATIENT, AND SUDDENLY THE CATHETER WAS TWISTED AND DAMAGED AND THE DOCTOR HAD TO DO SEVERAL MANEUVERS TO REMOVE IT. HE WAS FINALLY BEEN ABLE TO REMOVE IT FROM THE PATIENT WITHOUT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE DAMAGE DID NOT RESULT IN WIRES/INTERNAL COMPONENTS BEING EXPOSED OR LIFTED OR SHARP RINGS. IT WAS DIFFICULT TO ADVANCE DURING THE INSERTION OF THE CATHETER TO THE CORONARY SINUS, SO PHYSICIAN DECIDE TO REMOVE THE CATHETER AND IT WAS DIFFICULT AS WELL BECAUSE HE NOTICED UNDER X-RAY CATHETER SHAPED WAS BENT. FINALLY HE WAS ABLE TO REMOVE THE CATHETER OUT THE PATIENT. THE DOCTOR ALWAYS PRE-SHAPES THE CATHETER BEFORE INSERTION. THE SHEATH USED WAS A ABBOTT SHORT SHEATH 5FR. SHAFT BENT IS NOT MDR-REPORTABLE. MEDICAL DEVICE ENTRAPMENT WITH EXCESSIVE MANIPULATION REQUIRED IS MDR-REPORTABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14059556 ↗

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.