BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REBAR

    MDR report key: 21911016 · Received April 25, 2025

    Report

    Report Number
    2029214-2025-01067
    Event Type
    Malfunction
    Date Received
    April 25, 2025
    Date of Event
    April 22, 2025
    Report Date
    July 1, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    UDI-DI
    00847536026834
    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.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 103-0606-200 (LOT: B767091); PRODUCT TYPE: 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.

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS: ¿ AS FOUND CONDITION: THE REBAR-18 CATHETER AND AVIGO GUIDEWIRE WERE RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX AND A PLASTIC BIO-POUCH. ¿ VISUAL INSPECTION/DAMAGE LOCATION DETAILS: NO DAMAGE WAS FOUND WITH THE REBAR-18 CATHETER HUB. NO BENDS OR KINKS WERE FOUND WITH THE REBAR-18 CATHETER BODY. THE REBAR-18 CATHETER DISTAL TIP WAS FOUND TO BE IN GOOD CONDITION. NO BENDS OR KINKS WERE FOUND WITH THE AVIGO GUIDEWIRE PROXIMAL PUSHER. HOWEVER, THE AVIGO GUIDEWIRE DISTAL TIP WAS FOUND BENT. THE CHARACTERISTIC OF THE BENT GUIDEWIRE DISTAL TIP IS CONSISTENT WITH TIP SHAPING. ¿ TESTING/ANALYSIS: THE REBAR-18 CATHETER WAS FLUSHED AND THE AVIGO GUIDEWIRE WAS INSERTED THROUGH THE REBAR-18 CATHETER WITHOUT ISSUE. 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 WAS RECEIVED STATING THAT THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. PATIENT¿S BASELINE WAS UNKNOWN, BUT POST-THROMBECTOMY CONDITION: NIHSS GRADE 3. THE GUIDEWIRE WAS ABLE TO PASS THE CATHETER HUB. THERE WAS NO DAMAGE FOUND TO THE CATHETER. THE GUIDEWIRE TIP WAS NOT SHAPED. THERE WAS NO KINK DAMAGED FOUND ON THE GUIDEWIRE.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED REPORT THAT THE AVIGO GUIDEWIRE HAD RESISTANCE ADVANCING THROUGH THE MIDDLE SEGMENT OF THE REBAR MICROCATHETER DURING A THROMBECTOMY PROCEDURE VIA FEMORAL ARTERY ACCESS. THE GUIDEWIRE COULD NOT PASS THROUGH THE CATHETER. IT WAS NOTED THAT THE DEVICES WERE PREPARED AND CATHETER FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). BOTH DEVICES WERE REPLACED TO CONTINUE THE PROCEDURE. PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997264 REBAR CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 105-5081-153 B779556 00847536026834

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female SEE H11...