BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MILLIPEDE 088 ACCESS CATHETER

    MDR report key: 20953219 · Received December 17, 2024

    Report

    Report Number
    3015701715-2024-00006
    Event Type
    Injury
    Date Received
    December 17, 2024
    Date of Event
    May 24, 2024
    Report Date
    December 17, 2024
    Manufacturer
    PERFUZE LTD
    Product Code
    QJP
    PMA / PMN Number
    K233648
    Removal / Correction Number
    3015701715-2024-00005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A PATIENT WITH AN NIHSS OF 7 WAS TREATED FOR A LEFT DISTAL M1 MIDDLE CEREBRAL ARTERY (MCA) OCCLUSION. A THIRD PARTY 8F SHEATH WAS USED FOR ACCESS. THE MILLIPEDE 088 CATHETER WAS NAVIGATED OVER THE MILLIPEDE 070 CATHETER. THE MILLIPEDE CATHETERS WERE NAVIGATED OVER A THIRD-PARTY MICROCATHETER AND GUIDEWIRE. A MTICI SCORE OF 2C WAS ACHIEVED AFTER A SINGLE PASS WITH THE MILLIPEDE 088 ASPIRATION CATHETER. AFTER THE PROCEDURE THE SUBJECT'S NIHSS WAS 4. LATER THE SAME DAY, THE SUBJECT SUFFERED NEUROLOGICAL DETERIORATION (AN INCREASE OF 8 POINTS ON THE NIHSS). IT WAS DETERMINED THROUGH IMAGING THAT THE M2 SEGMENT OF THE MCA HAD OCCLUDED, WITHOUT HEMORRHAGIC TRANSFORMATION. A SECOND MECHANICAL THROMBECTOMY WAS PERFORMED WITH ANGIOPLASTY AND STENTING OF THE LEFT M1-M2 SEGMENT OF THE MCA. THE SUBJECT'S NIHSS AT 24 HOURS WAS 9. THE SUBJECT WAS TRANSFERRED TO A LOCAL HOSPITAL 3 DAYS AFTER THE PROCEDURE, AT WHICH POINT THE NIHSS WAS 6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1456441 MILLIPEDE 088 ACCESS CATHETER PERCUTANEOUS CATHETER QJP PERFUZE LTD DHR123

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Hospitalization ASPIRATION PUMP (PENUMBRA)| ASPIRATION TUBE SET (PERFUZE)| FLEXOR SHUTTLE GUIDING SHEATH (COOK)| MILLIPEDE 070 ASPIRATION CATHETER (PERFUZE)| TRANSEND GUIDEWIRE (STRYKER)| WEDGE MICROCATHETER (MICROVENTION)