BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MILLIPEDE 088 ACCESS CATHETER

    MDR report key: 23004671 · Received September 9, 2025

    Report

    Report Number
    3015701715-2025-00006
    Event Type
    Injury
    Date Received
    September 9, 2025
    Date of Event
    October 22, 2024
    Report Date
    September 9, 2025
    Manufacturer
    PERFUZE LTD
    Product Code
    QJP
    UDI-DI
    05391539370128
    PMA / PMN Number
    K242504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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 # 3015701715-2025-00005 FOR MILLIPEDE 070, MFR # 3015701715-2025-00006 FOR MILLIPEDE 088.

    Description of Event or Problem · 0

    THE PATIENT HAD A LEFT HEMISPHERE OCCLUSION OF THE PROXIMAL M1. THE PRE-PROCEDURE MTICI SCORE WAS EVALUATED AS 0. A MECHANICAL THROMBECTOMY 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, A MICROCATHETER AND GUIDEWIRE. AN MTICI SCORE OF 2C WAS ACHIEVED. FIVE HOURS POST PROCEDURE, THE PATIENT PRESENTED WITH A WORSENING NEUROLOGICAL EXAM AND A RE-OCCLUSION OF THE LEFT M1 WAS IDENTIFIED ON IMAGING. A SECOND THROMBECTOMY WAS PERFORMED, OBTAINING MTICI3. INTRACRANIAL ATHEROSCLEROTIC DISEASE WAS ALSO OBSERVED AND AN ELUTING CORONARY STENT WAS PLACED IN THE LEFT M1. THE EVENT WAS CONSIDERED A SERIOUS ADVERSE EVENT AS IT LED TO SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2333277 MILLIPEDE 088 ACCESS CATHETER PERCUTANEOUS CATHETER QJP PERFUZE LTD DHR151 05391539370128

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention ARISTOTLE 24 (SCIENTIA)| FLEXOR SHUTTLE GUIDING SHEATH (COOK)| MILLIPEDE 070 ASPIRATION CATHETER (PERFUZE)| RED 43 REPERFUSION CATHETER (PENUMBRA)