BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MILLIPEDE 070 ASPIRATION CATHETER

    MDR report key: 22458189 · Received July 9, 2025

    Report

    Report Number
    3015701715-2025-00003
    Event Type
    Injury
    Date Received
    July 9, 2025
    Date of Event
    October 8, 2024
    Report Date
    July 9, 2025
    Manufacturer
    PERFUZE LTD
    Product Code
    NRY
    UDI-DI
    05391539370081
    PMA / PMN Number
    K250012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICES WERE DISCARDED AFTER USE AND THEREFORE NOT AVAILABLE FOR RETURN AND INVESTIGATION. THERE WERE NO DEVICE DEFICIENCIES NOTED FOR THE MILLIPEDE 088 OR MILLIPEDE 070 CATHETERS. BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPEAT OCCLUSION IS UNKNOWN. A RELATIONSHIP BETWEEN THE EVENT AND THE MILLIPEDE CATHETERS COULD NOT BE CONFIRMED. IT IS UNCLEAR IF THE MILLIPEDE CATHETERS, THE THIRD-PARTY GUIDEWIRE OR THE THIRD-PARTY MICROCATHETER CONTRIBUTED TO THE EVENT. THE MANUFACTURING RECORDS FOR THE MILLIPEDE CATHETERS WERE REVIEWED AND DEMONSTRATED THAT THE PRODUCT MET ALL THE DESIGN AND MANUFACTURING SPECIFICATIONS. THE FOLLOWING MFR # WERE SUBMITTED: MFR # 3015701715-2025-00004 FOR MILLIPEDE 088.

    Description of Event or Problem · 0

    THE PATIENT HAD A LEFT HEMISPHERE OCCLUSION OF THE INTRACRANIAL ICA (CAROTID T OCCLUSION). THE PRE-PROCEDURE MTICI SCORE WAS EVALUATED AS 0. A MECHANICAL THROMBECTOMY PROCEDURE WAS PERFORMED USING THE MILLIPEDE 088 AND MILLIPEDE 070 CATHETERS. A THIRD-PARTY SHEATH WAS USED FOR ACCESS. THE MILLIPEDE 088 CATHETER WAS NAVIGATED TO THE CLOT OVER THE MILLIPEDE 070 CATHETER, A MICROCATHETER AND GUIDEWIRE. AN MTICI SCORE OF 2B WAS ACHIEVED. A RE-OCCLUSION OF THE LEFT CERVICAL ICA WAS IDENTIFIED ON CT PERFUSION TWO DAYS AFTER THE MECHANICAL THROMBECTOMY. NO TREATMENT OR ACTION WAS TAKEN. HOWEVER, THE EVENT WAS CONSIDERED LIFE THREATENING DUE TO POOR FLOW TO THE MCA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702711 MILLIPEDE 070 ASPIRATION CATHETER PERCUTANEOUS CATHETER NRY PERFUZE LTD DHR146 05391539370081

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Life Threatening HEADWAY MICROCATHETER (MICROVENTION)| MILLIPEDE 088 ASPIRATION CATHETER (PERFUZE)| SUPER ARROW-FLEX SHEATH (TELEFLEX)| SYNCHRO GUIDEWIRE (STRYKER)