CORPATH GRX
Received Sep 21, 2021 · Event occurred Aug 12, 2021
Report 3007822508-2021-00003 · MDR key 12509398
Device
Product problems
- Activation Problem
Patient
Not reported
- Chest Pain
- Chest Pain
Narrative
Description of Event or Problem
AFTER 1ST STENT PLACEMENT AN KB INFLATION (CRUX CORDS) PROXIMAL TO THE STENT IN 3RD SEG. OF RCA FLOW LIMITING DISSECTION APPEARED. THE ATTEMPT TO ROBOTICALLY DELIVER THE STENT TO COVER IT OR BALLOON TO DO ADDITIONAL LESION PREPARATION FAILED. DUE TO CLINICAL CONDITION (CHEST PAIN AND ECG CHANGES) DECISION WAS TO SWITCH TO MANUAL. AFTER SUCCESSFUL 2ND STENT IMPLANTATION AND CLINICAL STABILIZATION 3RD STENT AND FINAL BALLOONING DONE ONCE MORE ROBOTICALLY.
Additional Manufacturer Narrative
INCIDENT REPORTED TO THE MANUFACTURER ON 8/27/2021. THERE WAS NO PROBLEM WITH THE DEVICE DURING THE PROCEDURE AND THE PROCEDURE WAS COMPLETED. THE EVENT WAS NOT DEVICE RELATED AND IS A KNOWN RISK OF PCI PROCEDURES. THE DEVICE FUNCTIONED AS IT WAS INTENDED TO AND THERE WAS NO PROBLEM WITH THE WAY DEVICE WAS USED.