BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREECLIMB 70 REPERFUSION SYSTEM

    MDR report key: 20656277 · Received November 11, 2024

    Report

    Report Number
    3016522967-2024-00007
    Event Type
    Injury
    Date Received
    November 11, 2024
    Date of Event
    October 7, 2024
    Report Date
    October 7, 2024
    Manufacturer
    ROUTE 92 MEDICAL, INC.
    Product Code
    NRY
    UDI-DI
    00853799007541
    PMA / PMN Number
    K223530
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION THEREFORE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Description of Event or Problem · 0

    PATIENT WITH A MID-RIGHT M1 OCCLUSION. PENUMBRA BMX 96 SHEATH AND FREECLIMB 70 SYSTEM WERE USED AND ASPIRATION WAS INITIATED. CATHETERS WERE WITHDRAWN WITH SOME RESISTANCE, AND IT WAS FOUND THE FREECLIMB 70 TIP HAD SEPARATED. IMAGING SHOWED THE TIP EMBOLIZED TO THE ANTERIOR SEGMENT (A1/A2), BUT DID NOT CAUSE AN INFARCT AND BLOOD FLOW CONTINUED, THEREFORE REMOVAL WAS NOT ATTEMPTED. SECOND PASS WITH A NEW FREECLIMB 70 SYSTEM PERFORMED WITHOUT INCIDENT BUT UNSUCCESSFUL. THIRD PASS WITH A STENT RETRIEVER PERFORMED AND THE CLOT IN THE M1 WAS REMOVED. PHYSICIAN NOTED THE CLINICAL CONDITION OF THE PATIENT CONTINUED TO DETERIORATE FROM THE ORIGINAL INFARCT, AND THE EMBOLIZED TIP APPEARED TO HAVE NO CLINICAL IMPACT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2257419 FREECLIMB 70 REPERFUSION SYSTEM PERCUTANEOUS CATHETER NRY ROUTE 92 MEDICAL, INC. 24082103 00853799007541

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Other BMX 96 SHEATH.| FREECLIMB 70 SYSTEM.