FDA Adverse Event Malfunction Summary report: N

ECHELON 10 CATHETER

MDR report key: 18776917 · Received February 26, 2024

Report

Report Number
18776917
Event Type
Malfunction
Date Received
February 26, 2024
Date of Event
February 4, 2024
Report Date
February 9, 2024
Manufacturer
MICRO THERAPEUTICS, INC.
Product Code
KRA
Product Problem
Yes
Report Source
User Facility report
Reporter Location
FL
Reporter Occupation
RISK MANAGER
Health Professional
N

Narratives

Description of Event or Problem · 0

TRANSARTERIAL EMBOLIZATION OF THE OCCIPITAL ARTERY PERFORMED. DISTAL ACCESS INTO THE RIGHT OCCIPITAL ARTERY WAS OBTAINED WITH AN ECHELON 10 MICROCATHETER AND SYNCHRO 2 MICROWIRE. MICROCATHETER RUN DEMONSTRATED GOOD POSITIONING OF THE MICROCATHETER. THE CATHETER WAS THEN FLUSHED WITH DMSO AND ONYX18 WAS THEN SLOWLY INJECTED UNDER CONSTANT FLUOROSCOPIC GUIDANCE UTILIZING A BLANK ROADMAP. THREE VIALS OF ONYX 18 WAS USED WITH CARE TO AVOID REFLUX AS WE EMBOLIZED BACK TO THE INTERMEDIATE CATHETER. PERIODIC RUNS WERE PERFORMED CONFIRMING PROGRESSIVE EMBOLIZATION WITH SIGNIFICANT REDUCTION IN SUPPLY TO THE FISTULA. AT THIS POINT, WE ELECTED TO CONCLUDE THE PROCEDURE AND PERFORMED A STAGED APPROACH TO TREATMENT OF THIS COMPLEX FISTULA WITH MULTIPLE FEEDERS. WE ATTEMPTED TO WITHDRAW THE ECHELON 10 MICROCATHETER; HOWEVER, THERE WAS SIGNIFICANT RESISTANCE AND ULTIMATELY THE CATHETER FRACTURED. REMNANT CATHETER WAS OBSERVED WITHIN THE INTERMEDIATE CATHETER DOWN INTO THE COMMON CAROTID ARTERY. WE ATTEMPTED TO USE A GLIDEWIRE TO PUSH THE REMNANT CATHETER UP INTO THE OCCIPITAL ARTERY; HOWEVER, THE WIRE WAS SLIDING PAST THE CATHETER. THE PXS SLIM MICROCATHETER WAS THEN INTRODUCED INTO THE SOFIA AND WAS NOTED TO CAPTURE THE REMNANT ECHELON 10 MICROCATHETER. THE PXS SLIM MICROCATHETER WAS THEN ADVANCED INTO THE OCCIPITAL ARTERY AND A WIRE WAS USED TO PUSH OUT THE ECHELON 10 MICROCATHETER WHICH WAS NOTED TO BE COILED IN THE OCCIPITAL ARTERY. FINAL RUNS WERE PERFORMED DEMONSTRATING NO EVIDENCE OF ANY THROMBOEMBOLIC COMPLICATIONS AND DECREASED FILLING OF THE FISTULA.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1920315 ECHELON 10 CATHETER CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. 105-5091-150 B456169

Patients

Seq Age Sex Outcome Treatment
1 65 YR Male