BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REBAR

    MDR report key: 21701611 · Received March 26, 2025

    Report

    Report Number
    9612501-2025-00856
    Event Type
    Malfunction
    Date Received
    March 26, 2025
    Date of Event
    March 23, 2025
    Report Date
    March 26, 2025
    Manufacturer
    MEDTRONIC DOMINICANA
    Product Code
    KRA
    PMA / PMN Number
    K093750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    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

    IT WAS REPORTED THAT DURING A MECHANICAL THROMBECTOMY, THE 105-5081-153 REBAR IR MICROCATHETER EXPERIENCED SEVERAL DEVICE-RELATED ISSUES. THE CATHETER'S DISTAL SEGMENT BECAME FLOPPY AFTER THE FIRST PASS, AND A SMALL FRAGMENT SEPARATED FROM THE DISTAL CATHETER TIP. THE CATHETER WAS CRUSHED AT THE DISTAL LOCATION. THE CATHETER WAS PREPARED AND FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570786 REBAR CATHETER, CONTINUOUS FLUSH KRA MEDTRONIC DOMINICANA 105-5081-153 0227836939

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown