BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK CORONARY

    MDR report key: 20248666 · Received September 18, 2024

    Report

    Report Number
    3004742232-2024-00335
    Event Type
    Injury
    Date Received
    September 18, 2024
    Date of Event
    August 22, 2024
    Report Date
    October 8, 2024
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCX
    PMA / PMN Number
    P130005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS INACCURATELY MARKED AS AVAILABLE FOR RETURN IN THE INITIAL REPORT. THE DEVICES ARE NOT AVAILABLE FOR RETURN. CSI ID: (B)(4).

    Additional Manufacturer Narrative · 0

    D10: MODEL NUMBER: GWC-12325LG-FT. CATALOG NUMBER: 7-10038-01. LOT NUMBER: 457059-1. UDI: (B)(4). EXPIRATION DATE: 1/31/2024. MANUFACTURING DATE:10/12/2022. H6: 4019 IS ASSOCIATED WITH THE ORBITAL ATHERECTOMY DEVICE AND 1562 IS ASSOCIATED WITH THE VIPERWIRE ADVANCE GUIDE WIRE. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. CSI ID: (B)(4).

    Description of Event or Problem · 0

    A VIPERWIRE ADVANCE GUIDE WIRE FLEX TIP WAS ADVANCED DOWN A HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD) THROUGH THE GROIN ACCESS SITE. NEXT, THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS ADVANCED, AND ONCE OUT OF THE GUIDE CATHETER, GLIDEASSIST MODE WAS ACTIVATED. THE OAD POWERED OFF ON ITS OWN AND WAS UNABLE TO BE POWERED BACK ON. THE OAD WAS REMOVED FROM THE PATIENT. NEXT, A MICROCATHETER WAS ADVANCED TO ASSIST WITH EXCHANGING THE VIPERWIRE OUT FOR A WORKHORSE WIRE. AS THE VIPERWIRE WAS BEING PULLED BACK, THE PHYSICIAN FELT RESISTANCE AND THE TIP OF THE VIPERWIRE WAS OBSERVED DISLODGED IN THE DISTAL LAD. THE REMAINDER OF THE VIPERWIRE WAS REMOVED. A SNARE WAS ATTEMPTED TO BE USED TO RETRIEVE THE FRACTURED COMPONENT, HOWEVER, THIS WAS UNSUCCESSFUL. THE FRACTURED COMPONENT REMAINED IN THE PATIENT. A NON-ABBOTT DEVICE AND A XIENCE STENT WAS PLACED TO COMPLETE THE PROCEDURE. IN THE PHYSICIAN'S OPINION, THE VIPERWIRE MAY HAVE CAUGHT ONTO CALCIUM UPON REMOVAL, LEADING TO THE FRACTURE. THE PATIENT WAS HOSPITALIZED FOR 24 HOURS AND DISCHARGED IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1319251 DIAMONDBACK CORONARY CORONARY ATHERECTOMY DEVICE MCX CARDIOVASCULAR SYSTEMS, INC. DBEC-125

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O| H VIPERWIRE ADVANCE GUIDE WIRE