BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REBAR CATHETER

    MDR report key: 20873047 · Received December 6, 2024

    Report

    Report Number
    2029214-2024-02253
    Event Type
    Malfunction
    Date Received
    December 6, 2024
    Date of Event
    November 7, 2024
    Report Date
    December 6, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    PMA / PMN Number
    K093750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING A SOLITAIRE AB (SAB) THAT HAD RESISTANCE DURING DELIVERY AND BECAUSE KINKED/DAMAGED. IT WAS REPORTED THAT THE SAB AND ALL ACCESSORY DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THE MICROCATHETER WAS FLUSHED AND DELIVERED NORMALLY. HOWEVER, DURING DELIVERY OF THE SAB INTO THE MICROCATHETER, THE SAB WAS STUCK AT "THE TERMINAL." RESISTANCE WAS SEVERE AND THE SAB COULD NOT BE ADVANCED. THE SAB WAS THEN REMOVED AND IT WAS OBSERVED THE TIP WAS KINKED AT THE WELDING POINT. THE SAB WAS REPLACED WITH ANOTHER OF THE SAME MODEL TO COMPLETE THE PROCEDURE SUCCESSFULLY. ONLY ONE PASS WAS MADE WITH THE COMPLAINT SAB DEVICE. THE RESISTANCE OCCURRED AT THE RELATIVE MIDSECTION OF THE CATHETER. THERE WAS NO HARM OR INJURY TO THE PATIENT WHO WAS UNDERGOING A PROCEDURE TO TREAT ISCHEMIC STROKE AT THE INTERNAL CAROTID ARTERY (ICA) TERMINUS. IT WAS NOTED THAT IV TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS NOT CONTRAINDICATED. THE PATIENT'S BASELINE MRS WAS 5, NIHSS WAS 17, AND TICI WAS 0. A TICI OF 2B WAS ACHIEVED WITH THE PROCEDURE. POST-OPERATIVE MRS REMAINED 5 AND NIHSS WAS IMPROVED TO 13. PATIENT VESSEL TORTUOSITY WAS MINIMAL. STROKE ONSET TO REPERFUSION TIME WAS 5.5 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2114167 REBAR CATHETER CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 105-5081-153 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female