BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 8583728 · Received May 6, 2019

    Report

    Report Number
    3004742232-2019-00128
    Event Type
    Malfunction
    Date Received
    May 6, 2019
    Date of Event
    April 8, 2019
    Report Date
    May 6, 2019
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCW
    UDI-DI
    10852528005022
    PMA / PMN Number
    K110389
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE OAD WAS RECEIVED FOR ANALYSIS. VISUAL EXAMINATION REVEALED AN INSUFFICIENT AMOUNT OF UV ADHESIVE IN THE SEAL AROUND THE NOSECONE CAP. A SYRINGE FILLED WITH FLUID WAS INJECTED INTO THE OAD AND THE FLUID WAS OBSERVED TO BE LEAKING OUT OF THE NOSECONE CAP. THERE WAS NO OTHER DAMAGE OBSERVED WITH THE OAD. AT THE CONCLUSION OF THE ANALYSIS, THE REPORTED ISSUE THAT THE OAD WAS FOUND TO BE LEAKING WAS CONFIRMED. THE ROOT CAUSE WAS REVEALED TO BE A MANUFACTURING ISSUE WHERE AN INSUFFICIENT AMOUNT OF ADHESIVE HAD BEEN APPLIED AT THE NOSECONE CAP. THE DEVICE HISTORY RECORD FOR THIS OAD LOT NUMBER HAS BEEN REVIEWED. NO ISSUES OR DISCREPANCIES WERE NOTED DURING THIS REVIEW THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE MET MATERIAL, ASSEMBLY, AND QUALITY CONTROL REQUIREMENTS. CS ID: (B)(4).

    Description of Event or Problem · 1

    DURING PRIMING OF THE PERIPHERAL STEALTH ORBITAL ATHERECTOMY DEVICE (OAD), THE OAD WAS NOTED TO BE LEAKING VIPERSLIDE FROM THE STRAIN RELIEF. THE OAD WAS ADVANCED THROUGH THE SHEATH AND BLOOD WAS NOTED TO BE FLOWING BACK THROUGH THE SALINE SHEATH. THE DEVICE WAS REPLACED WITH A SECOND OAD TO COMPLETE THE PROCEDURE AND THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375419 DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY DEVICE MCW CARDIOVASCULAR SYSTEMS, INC. DBE-200 251125 10852528005022

    Patients

    Seq Age Sex Outcome Treatment
    1