BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.14 GUIDEWIRES

    MDR report key: 21322721 · Received February 6, 2025

    Report

    Report Number
    2029214-2025-00312
    Event Type
    Malfunction
    Date Received
    February 6, 2025
    Date of Event
    February 4, 2025
    Report Date
    March 4, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    DQX
    UDI-DI
    00763000338275
    PMA / PMN Number
    K113454
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 190-5091-150 (B698438); IMPLANT DATE N/A; EXPLANT DATE N/A. 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED THAT VESSEL TORTUOSITY WAS NORMAL. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT DISCHARGED. THE GUIDEWIRE WAS ABLE TO PASS THE CATHETER HUB. THE AVIGO WAS STUCK INSIDE AND THERE IS A RESISTANCE FELT. THE GUIDEWIRE TIP WAS NOT SHAPED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING AN AVIGO GUIDEWIRE THAT HAD RESISTANCE/WAS STUCK IN THE ECHELON 10 MICRO CATHETER. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AND CATHETER WAS FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE ECHELON 10 MICROCATHETER WAS CAREFULLY REMOVED FROM THE RETAINER HOOP AND FLUSHED. IT WAS INSERTED IN THE RHV AND THE AVIGO GUIDEWIRE WAS IMMEDIATELY INSERTED. THE GUIDEWIRE WAS ADVANCED UNTIL THE MIDDLE SEGMENT OF THE CATHETER, WHERE RESISTANCE WAS FELT AND THE AVIGO DID NOT CONTINUE ADVANCING THROUGH THE CATHETER. THE SURGEON TRIED TO REMOVE THE GUIDEWIRE BUT IT WAS STUCK IN THE CATHETER. THE WHOLE SYSTEM WAS REMOVED AND REPLACED FOR THE PROCEDURE.  SUBSEQUENTLY, THE GUIDEWIRE WAS FORCEFULLY EXTRACTED FROM THE MICROCATHETER IN VITRO AND BROKE; IT WAS OBSERVED THAT A PART HAD SEPARATED FROM THE PRIMARY WIRE. NO PATIENT INFORMATION WAS REPORTED AND THE GUIDEWIRE BREAK OCCURRED OUTSIDE THE PATIENT'S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298669 0.14 GUIDEWIRES WIRE, GUIDE, CATHETER DQX MICRO THERAPEUTICS, INC. DBA EV3 103-0606-200 B610703 00763000338275

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11...