BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MILLIPEDE 088 ACCESS CATHETER

    MDR report key: 20851300 · Received December 5, 2024

    Report

    Report Number
    3015701715-2024-00004
    Event Type
    Injury
    Date Received
    December 5, 2024
    Date of Event
    July 28, 2024
    Report Date
    December 4, 2024
    Manufacturer
    PERFUZE LTD
    Product Code
    QJP
    UDI-DI
    05391539370142
    PMA / PMN Number
    K233648
    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 MALFUNCTIONS NOTED FOR THE MILLIPEDE 088 OR MILLIPEDE 070 CATHETERS. BASED ON THE INFORMATION PROVIDED, THE EXACT CAUSE OF THE EVENTS IS UNKNOWN. THE RELATIONSHIP OF THE MILLIPEDE CATHETERS TO THE EVENTS COULD NOT BE ESTABLISHED. IT IS UNCLEAR IF THE EVENTS WERE CAUSED BY THE MILLIPEDE CATHETERS, THE THIRD-PARTY GUIDEWIRE OR THE THIRD-PARTY MICROCATHETER. 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 # 3015701715-2024-00003 FOR MILLIPEDE 070,

    Description of Event or Problem · 0

    A PATIENT WITH A NIHSS SCORE OF 17 AND BASELINE MTICI SCORE OF 0 WAS TREATED FOR A LEFT MIDDLE CEREBRAL ARTERY OCCLUSION. A THIRD PARTY 8F SHEATH WAS USED FOR ACCESS. THE MILLIPEDE 088 CATHETER WAS NAVIGATED OVER A MILLIPEDE 070 CATHETER. THE MILLIPEDE CATHETERS WERE NAVIGATED OVER A THIRD PARTY MICROCATHETER AND GUIDEWIRE. IT WAS RECORDED THAT THE CLOT WAS CROSSED WITH THE THIRD PARTY MICROCATHETER AND GUIDEWIRE DURING EACH PASS. AFTER 3 PASSES, IT WAS NOTED THAT THERE WAS EMBOLIZATION OF CLOT TO THE LEFT ANTERIOR CEREBRAL ARTERY. A THIRD PARTY STENTRIEVER WAS USED IN COMBINATION WITH ASPIRATION FOR TWO SUBSEQUENT PASSES, BUT THE EMBOLUS COULD NOT BE RETRIEVED. THE FINAL MTICI SCORE AT THE END OF THE PROCEDURE WAS 2B. FOLLOWING THE PROCEDURE, THE PATIENT RAPIDLY DETERIORATED AND THE PATIENT'S FAMILY DECLINED FURTHER CONTINUANCE OF CARE. THE PATIENT DIED 5 DAYS AFTER THE PROCEDURE. THE TREATING PHYSICIAN ATTRIBUTED THE DEATH TO THE SEVERITY OF THE STROKE AND THE PATIENT'S AGE. ACCORDING TO THE PHYSICIAN, THE STROKE WAS RAPIDLY EVOLVING TO A LARGER ISCHEMIC STROKE WHICH LED TO EARLY NEUROLOGICAL DETERIORATION DESPITE ARTERIAL RECANALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1850487 MILLIPEDE 088 ACCESS CATHETER PERCUTANEOUS CATHETER QJP PERFUZE LTD DHR143 05391539370142

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Disability 027 HEADWAY MICROCATHETER (MICROVENTION)| 8F SUPER ARROW-FLEX SHEATH (TELEFLEX)| ASPIRATION PUMP (PENUMBRA)| CHIKAI 18 GUIDEWIRE (ASAHI)| EMBOTRAP 5MM X 37MM (CERENOVOUS)| MILLIPEDE 070 ASPIRATION CATHETER (PERFUZE)