Skip to content

WEBSTER D7DR252RTRecalls & reported problems

Biosense Webster Inc · 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 10846835005646), received between Feb 20, 2018 and Feb 20, 2018 — 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
  • No Code Available1

Recent adverse event reports

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

  • InjuryFeb 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ORIGINALLY, THIS EVENT WAS REPORTED UNDER THE THERMOCOOL SMARTTOUCH BIDIRECTIONAL SF CATHETER. HOWEVER, ADDITIONAL INFORMATION WAS RECEIVED ON JANUARY 25, 2018 PROVIDING THE RIGHT VENTRICLE (RV) CATHETER PRODUCT INFORMATION OF WEBSTER¿ ELECTROPHYSIOLOGY CATHETER. THEREFORE, SINCE THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT THERE WAS A POSSIBLE PERFORATION WHILE ADVANCING THE RV CATHETER INTO THE RV, IT HAS BEEN ASSESSED TO ALSO REPORT THIS EVENT UNDER THE WEBSTER¿ ELECTROPHYSIOLOGY CATHETER. THE AWARENESS DATE IS JANUARY 25, 2018 FOR THIS REPORT. IT WAS REPORTED THAT AN (B)(6) FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR VENTRICULAR TACHYCARDIA WITH A WEBSTER¿ ELECTROPHYSIOLOGY CATHETER AND THERMOCOOL SMARTTOUCH BIDIRECTIONAL SF CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND SURGICAL INTERVENTION. AFTER TRANSSEPTAL PUNCTURE AND AFTER MAPPING WITH THE THERMOCOOL SMARTTOUCH BIDIRECTIONAL SF CATHETER, BUT PRIOR TO ANY ABLATION, THE PATIENT BECAME HYPOTENSIVE. PERICARDIAL EFFUSION WAS CONFIRMED VIA ULTRASOUND. PERICARDIOCENTESIS YIELDED 1000 ML OF FLUID. PATIENT WAS SENT FOR A SURGICAL REPAIR TO PATCH THE RIGHT VENTRICULAR

    Patient problems: Cardiac Tamponade; No Code Available

    MAUDE report 7284743 ↗

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.