ECHELON
Report
- Report Number
- 9612501-2025-01619
- Event Type
- Malfunction
- Date Received
- June 25, 2025
- Date of Event
- May 14, 2025
- Report Date
- July 25, 2025
- Manufacturer
- MEDTRONIC DOMINICANA
- Product Code
- KRA
- UDI-DI
- 00763000412326
- PMA / PMN Number
- K093750
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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 RECEIVED A REPORT THAT THE SURGEON ROUTINELY USED 103-0606-200 GUIDE WIRE, BUT REPORTED THAT THIS GUIDE WIRE WAS NOT AS SMOOTH AS BEFORE. THE FIRST GUIDE WIRE FELT VERY ASTRINGENT (WITH GREAT RESISTANCE), COULD NOT GO UPPER TO THE LESION AREA, AND WAS VERY DIFFICULT TO PASS THROUGH THE SIPHON BEND. DURING THE SURGERY, A DIFFERENT GUIDE WIRE WAS TRIED, BUT THE RESULT WAS THE SAME. THE ECHELON WAS NOT DAMAGED AND CONTINUED TO BE USED NORMALLY DURING THE SURGERY. IT WAS NOTED THAT THIS LOT (B767109) HAS HAD MULTIPLE SIMILAR REPORTS. THE SURGEON WAS EXPERIENCED AND THE DEVICE WAS FULLY HYDRATED. THE MICROCATHETER MATCHED THE MICROGUIDEWIRES OF THE SAME DIAMETER OF OTHER BRANDS WITHOUT MUCH RESISTANCE. THEREFORE, THE SURGEON AND THE DISTRIBUTOR INITIALLY DETERMINED THAT THIS WAS A SPECIAL CIRCUMSTANCES OF THIS LOT OF GUIDEWIRES. 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. THE PATIENT WAS UNDERGOING SURGERY FOR THROMBOLYTIC THERAPY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY. PATIENT MEDICAL HISTORY: NO UNDERLYING DISEASE, ALCOHOLISM AND SMOKING, ETC. ANCILLARY DEVICES INCLUDE A 6F GUIDING.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE SURGERY WAS COMPLETED BY REPLACING THE GUIDEWIRE. THE CUSTOMER THOUGHT THE EVENT MIGHT HAVE BEEN CAUSED BY THE GUIDEWIRE. THE GUIDEWIRE WAS ABLE TO PASS THROUGH THE CATHETER HUB. THERE WAS NO DAMAGE FOUND TO THE CATHETER HUB. THE GUIDEWIRE TIP HAD BEEN SHAPED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1069670 | ECHELON | CATHETER, CONTINUOUS FLUSH | KRA | MEDTRONIC DOMINICANA | 105-5091-150 | 0229237872 | 00763000412326 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Female |