BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 19485008 · Received June 7, 2024

    Report

    Report Number
    3004742232-2024-00202
    Event Type
    Injury
    Date Received
    June 7, 2024
    Date of Event
    May 9, 2024
    Report Date
    July 3, 2024
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC. (ABBOTT)
    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

    D10 VIPERWIRE ADVANCE CORONARY GUIDE WIRE INFORMATION: MODEL NUMBER: GWC-12325LG-FT. LOT NUMBER: 458264-1. MANUFACTURING DATE: 19 OCTOBER 2022. EXPIRATION DATE: 31 OCTOBER 2024. UDI: (B)(4). THE DEVICE HISTORY RECORD FOR THE REPORTED OAD COULD NOT BE REVIEWED AS THE LOT NUMBER WAS NOT PROVIDED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE REPORTED DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE MATERIAL INSPECTION REPORT FOR THIS GUIDE WIRE 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. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE REPORTED DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM INSTRUCTIONS FOR USE MANUAL WARNS: ENSURE FLUOROSCOPY PROVIDES ADEQUATE VISUALIZATION OF THE OAS SYSTEM. ALWAYSUSE FLUOROSCOPY TO MONITOR THE GUIDE WIRE SPRING TIP AND DRIVESHAFT POSITIONS AT ALL TIMES THROUGHOUT THE PROCEDURE. IF WIRE MOVEMENT OCCURS, IT IS SUGGESTED TO REPOSITION THE GUIDE WIRE BEFORE ADVANCING THE DEVICE OR CONTINUING TREATMENT. (B)(4).

    Additional Manufacturer Narrative · 0

    CSI ID: (B)(4).

    Description of Event or Problem · 0

    FOLLOWING TEN TO THIRTEEN TREATMENTS OF A TIGHT HEAVILY CALCIFIED LESION IN THE MID RIGHT CORONARY ARTERY (RCA) VIA FEMORAL ACCESS USING DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD), THE VIPERWIRE ADVANCE CORONARY GUIDE WIRE WITH FLEX TIP CAME BACK PROXIMAL. THE VESSEL WAS PRIMARY WIRED WITH THE VIPERWIRE. THE OAD CROWN WAS ABLE TO CROSS THE LESION, BUT IT JUMPED FORWARD AND CAME IN CONTACT WITH THE VIPERWIRE RADIOPAQUE TIP, SHEARING IT OFF. IN THE OPINION OF THE PHYSICIAN, THE EVENT OCCURRED DUE TO NOT MONITORING THE VIPERWIRE SPRING TIP DISTANCE FROM THE OAD DRIVESHAFT TIP. ATTEMPTS TO SNARE THE RADIOPAQUE TIP WERE UNSUCCESSFUL BECAUSE THEY WERE UNABLE TO GET THE SNARE TO THE RCA. THE FRACTURED COMPONENT REMAINED IN VIVO. STENT PLACEMENT WAS PERFORMED TO COMPLETE THE PROCEDURE. THE PATIENT WAS STABLE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE LESION WAS 75-95% STENOSED REQUIRING PERCUTANEOUS CORONARY INTERVENTION (PCI).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1259573 DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM CORONARY ORBITAL ATHERECTOMY SYSTEM MCX CARDIOVASCULAR SYSTEMS, INC. (ABBOTT) DBEC-125

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention| O VIPERWIRE ADVANCE CORONARY GUIDE WIRE