BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE)

    MDR report key: 10733303 · Received October 26, 2020

    Report

    Report Number
    3004742232-2020-00336
    Event Type
    Malfunction
    Date Received
    October 26, 2020
    Date of Event
    September 17, 2020
    Report Date
    October 26, 2020
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCW
    PMA / PMN Number
    K190634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE RECEIVED BY MANUFACTURER: THE EVENT WAS REPORTED TO CSI ON (B)(6) 2020, BUT THE REPORT DID NOT INCLUDE REPORTABLE INFORMATION AT THAT TIME. REPORTABLE INFORMATION WAS PROVIDED ON 10/4/2020. DEVICE ANALYSIS CONCLUSION: THE OAD WAS RETURNED WITH THE GUIDEWIRE ENGAGED. ANALYSIS IDENTIFIED THE WIRE AS A WIRE INTENDED FOR USE WITH A PERIPHERAL OAD. THE OAD WAS TESTED AND FUNCTIONED AS INTENDED. THE FAILURE IS CONSIDERED USER ERROR SINCE AN INCOMPATIBLE WIRE WAS USED. AT THE CONCLUSION OF THE DEVICE ANALYSIS INVESTIGATION, THE REPORTED INABILITY OF THE WIRE TO ADVANCE THROUGH THE OAD WAS CONFIRMED. THE DIAMONDBACK 360® CORONARY ORBITAL ATHERECTOMY SYSTEM INSTRUCTIONS FOR USE MANUAL STATES, "DO NOT USE OTHER COMMERCIALLY-AVAILABLE GUIDE WIRES WITH THE OAD. ONLY USE THE MODEL GWC-12325LG-FLP VIPERWIRE ADVANCE® OR GWC-12325LG-FT VIPERWIRE ADVANCE® WITH FLEX TIP CORONARY GUIDE WIRE WITH THE CORONARY OAD. THE VIPERWIRE GUIDE WIRE IS DESIGNED FOR USE WITH ALL CORONARY OAD CROWN AND SHAFT CONFIGURATIONS." THE MATERIAL INSPECTION REPORT FOR THE REPORTED GUIDE WIRE COULD NOT BE REVIEWED, AS THE LOT NUMBER WAS NOT PROVIDED. CSI ID: (B)(4).

    Description of Event or Problem · 1

    THE ORBITAL ATHERECTOMY DEVICE (OAD) COULD NOT BE ADVANCED OVER THE VIPERWIRE DURING DEVICE PREPARATION AND LOADING. THE WIRE BECAME COMPLETELY STUCK IN THE OAD AND COULD NOT BE REMOVED. THE PROCEDURE WAS CONTINUED WITH NON-CSI DEVICES. THE PROCEDURE WAS DELAYED BY 30 MINUTES OR MORE DUE TO THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1200774 DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE) PERIPHERAL ATHERECTOMY DEVICE (GUIDE WIRE) MCW CARDIOVASCULAR SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1