BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MILLIPEDE 088 ACCESS CATHETER

    MDR report key: 22097345 · Received May 28, 2025

    Report

    Report Number
    3015701715-2025-00002
    Event Type
    Injury
    Date Received
    May 28, 2025
    Date of Event
    October 23, 2024
    Report Date
    May 28, 2025
    Manufacturer
    PERFUZE LTD
    Product Code
    QJP
    UDI-DI
    05391539370128
    PMA / PMN Number
    K232524
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 RELATED TO THE UNDERLYING STENOSIS. 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 # 3015701715-2025-00001 FOR MILLIPEDE 070, MFR # 3015701715-2025-00002 FOR MILLIPEDE 088.

    Description of Event or Problem · 0

    THE PATIENT PRESENTED WITH A LEFT INTRACRANIAL ICA OCCLUSION. THEY HAD SEVERE INTRACRANIAL ARTERIAL DISEASE (ICAD) AND A HISTORY OF ISCHEMIC STROKE. IT WAS NOTED THAT THEY WERE NOT TAKING ASPIRIN OR PLAVIX FOR THE 2 MONTHS PRIOR TO THIS EVENT. BASELINE CTA IMAGING SHOWED AN MTICI SCORE OF 2C AND SEVERE STENOSIS IN THE LEFT ICA. IT WAS THE PHYSICIAN'S OPINION THAT A PARTIAL CLOT IN THE REGION COULD NOT BE EXCLUDED, SO A MECHANICAL THROMBECTOMY WAS PERFORMED USING THE MILLIPEDE 088 AND MILLIPEDE 070 CATHETERS. A THIRD PARTY 8F SHEATH WAS USED FOR ACCESS. THE MILLIPEDE 088 CATHETER WAS NAVIGATED TO THE CLOT OVER THE MILLIPEDE 070 CATHETER, WHICH WAS SUPPORTED BY A THIRD PARTY MICROCATHETER AND GUIDEWIRE. AN MTICI SCORE OF 2C WAS ACHIEVED AFTER ONE PASS. ACCORDING TO THE PHYSICIAN, NO THROMBUS WAS OBTAINED BUT THERE WAS PERSISTENT SEVERE STENOSIS. NO PROCEDURAL COMPLICATIONS WERE RECORDED. A FEW HOURS AFTER THE PROCEDURE THE PATIENT HAD A WORSENING NEURO EXAM AND REPEAT IMAGING SHOWED A NEW OCCLUSION IN THE SAME REGION AS THE ORIGINAL STROKE (SUPERCLINOIDAL ICA, AT THE SITE OF THE STENOSIS). THE SUBJECT WAS TREATED WITH ASPIRIN AND TICAGRELOR AND ANOTHER MECHANICAL THROMBECTOMY PROCEDURE WAS PERFORMED SUCCESSFULLY. THE EVENT RESOLVED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889092 MILLIPEDE 088 ACCESS CATHETER PERCUTANEOUS CATHETER QJP PERFUZE LTD DHR153 05391539370128

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Required Intervention ARISTOTLE 18 GUIDEWIRE (SCIENTIA).| ASPIRATION PUMP (PENUMBRA).| ASPIRATION TUBE SET (PERFUZE).| FLEXOR SHUTTLE GUIDING SHEATH (COOK).| MILLIPEDE 070 ASPIRATION CATHETER (PERFUZE).| REBAR 18 MICROCATHETER (MEDTRONIC).