ST. JUDE MEDICAL
Received Apr 16, 2019 · Event occurred Mar 15, 2019
Report 3032391-2019-00008 · MDR key 8520390
Device
Generic name
Agilis Nxt Steerable Introducer 22.4mm Curl Dimension 8.5fr X 71cm
Manufacturer
Medline RenewalCatalog number
408310RH
Lot number
UNK
Product problems
- Break
Patient
Not reported
- Cardiac Tamponade
- Cardiac Tamponade
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT A REPROCESSED ST. JUDE MEDICAL'S AGILIS NXT STEERABLE INTRODUCER, 22.4MM CURL DIMENSION 8.5FR X 71CM, BROKE DURING AN ABLATION. PER REPORT, THE PATIENT WENT INTO CARDIAC TAMPONADE AND THE PHYSICIAN DRAINED THE ACCUMULATED FLUIDS. IT WAS ADDED THAT THE PHYSICIAN IS CONCERNED THAT THE "BLUNT PORTION IS TOO BLUNT" AND THAT DIFFICULTY WAS ENCOUNTERED WHEN CROSSING THE SEPTUM. DUE TO THE REPORTED EVENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. THE DEVICE USED FOR THE PROCEDURE WAS RETURNED TO INNOVATIVE HEALTH (REPROCESSOR OF ELECTROPHYSIOLOGY CATHETER DEVICES FOR MEDLINE RENEWAL) FOR EVALUATION AND THE COMPLAINT COULD NOT BE CONFIRMED. IT WAS REPORTED THAT THE DEVICE FUNCTIONED AS EXPECTED. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT THE REPROCESSED AGILIS NXT STEERABLE INTRODUCER BROKE DURING AN ABLATION AND PATIENT DEVELOPED CARDIAC TAMPONADE.