ECHELON
Report
- Report Number
- 9612501-2025-00478
- Event Type
- Malfunction
- Date Received
- February 19, 2025
- Date of Event
- February 18, 2025
- Report Date
- April 17, 2025
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- KRA
- UDI-DI
- 00847536005983
- PMA / PMN Number
- K093750
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PRODUCT ANALYSIS: AS FOUND CONDITION: THE ECHELON-14 MICRO CATHETER AND AXIUM PRIME DEVICE WERE RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX; WITHIN A SEALED TYVEK BIOHAZARD POUCH AND WITHIN THEIR OPENED INNER POUCHES. VISUAL INSPECTION/DAMAGE LOCATION DETAILS: NO DAMAGES OR IRREGULARITIES WERE FOUND WITH THE ECHELON-14 HUB. NO BENDS OR KINKS WERE FOUND WITH THE ECHELON-14 CATHETER BODY. LIQUID BLOOD WAS FOUND THROUGHOUT THE MICRO CATHETER. NO DAMAGES WERE FOUND WITH THE ECHELON-14 DISTAL TIP OR MARKER BANDS. TESTING/ANALYSIS: THE AXIUM PRIEM DEVICE COULD NOT BE USED FOR RESISTANCE TESTING DUE TO THE DAMAGED CONDITION. THE ECHELON-14 TOTAL LENGTH WAS MEASURED TO BE ~155.1CM AND THE USEABLE LENGTH WAS MEASURED TO BE ~147.2CM WHICH IS WITHIN SPECIFICATION (SPECIFICATION: TOTAL (REF) = 155CM; USABLE = 147.0 CM ± 1.5CM). THE ECHELON-14 MICRO CATHETER WAS FLUSHED, WATER AND THE BLOOD EXITED FROM THE DISTAL TIP WITH NO OCCLUSIONS FOUND. AN IN-HOUSE COIL (MODEL: APB-4-6-HX-SS LOT: A143100) WAS INSERTED INTO THE HUB WITH INITIAL RESISTANCE ENCOUNTERED, THEN THROUGH THE MICRO CATHETER AND OUT THE DISTAL END WITH NO ADDITIONAL RESISTANCE ENCOUNTERED. THE INNER DIAMETER OF THE HUB WAS MEASURED TO BE 0.0165¿, WHICH IS WITHIN SPECIFICATION (SPECIFICATION: 0.0165¿ MINIMUM). NO GAP WAS FOUND BETWEEN THE HUB AND GRILAMID. HOWEVER, A STEP WAS FOUND BETWEEN THE GRILAMID AND PROXIMAL CATHETER. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
ADDITIONAL INFORMATION RECEIVED REPORTED DOCTORS IN THIS DEPARTMENT HAD FEW TIMES PROBLEMS WITH ECHELON, BUT THEY DIDN¿T REPORT IT. THE COIL COME OUT OF THE INTRODUCER SHEATH SMOOTHLY. EVERYTHING WAS DONE AND INDICATED IN THE INSTRUCTUTIONS FOR USE (IFU).
MEDTRONIC RECEIVED A REPORT THAT AND ECHELON CATHETER HAD A LEAK AND AN AXIUM COIL ENCOUNTERED RESISTANCE AND WAS STUCK AT THE CATHETER HUB. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE DOCTOR TRIED TO EMBOLIZE THE ANEURYSM WITH THE ECHELON AND COIL, BUT THE COIL GOT STUCK AT THE ECHELON HUB AND COULDN'T GET THROUGH BECAUSE OF A "BLOCKADE". THE DOCTOR CHANGED THE MICROCATHETER AND THE COIL TO ANOTHER MANUFACTURER'S. IT WAS NOTED THE CATHETER WAS INSPECTED PRIOR TO USE. THE CATHETER AND COIL WERE NOTED TO BE DAMAGED. IT WAS STATED THAT IT WASN'T THE FIRST TIME IN THIS HOSPITAL THAT THERE WERE PROBLEMS WITH THE HUB OF THE ECHELON. THE REPORTED DEVICES AND ANY ACCESSORY DEVICES WERE PREPARED AND THE CATHETER WAS FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES INCLUDE A GUIDEWIRE AND AXIUM COILS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 43569 | ECHELON | CATHETER, CONTINUOUS FLUSH | KRA | MICRO THERAPEUTICS, INC. DBA EV3 | 105-5092-150 | B711025 | 00847536005983 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | SEE H11... |