SWAN-GANZ BIPOLAR PACING CATHETER FOR FEMORAL INSERTION
Received Mar 27, 2025 · Event occurred Mar 10, 2025
Report 2015691-2025-02333 · MDR key 21715463
Device
Generic name
Electrode, Pacemaker, Temporary
Manufacturer
Edwards LifesciencesModel number
PE075F5Lot number
65651123
Product problems
- Pacing Problem
- Pacing Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
AS REPORTED, RIGHT AFTER INSERTION IN THE PATIENT, A SWAN-GANZ PACING CATHETER DID NOT PACE. WHEN THE CATHETER WAS REPLACED, THE PROBLEM WAS SOLVED. THERE WAS NO ALLEGATION OF PATIENT INJURY.
Additional Manufacturer Narrative
THE DEVICE EVALUATION IS ANTICIPATED. HOWEVER, THE COMPLAINT CANNOT BE CONFIRMED WITHOUT THE COMPLETION OF A PRODUCT EVALUATION. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS A PART OF THE MONTHLY REVIEW.