BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 16077556 · Received December 30, 2022

    Report

    Report Number
    3004742232-2022-00305
    Event Type
    Malfunction
    Date Received
    December 30, 2022
    Date of Event
    September 29, 2022
    Report Date
    August 5, 2024
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCX
    PMA / PMN Number
    P130005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE OAD WAS RETURNED TO CSI FOR ANALYSIS WHICH IDENTIFIED THE PRESENCE OF MATERIAL WITHIN THE DRIVESHAFT OF THE OAD. THE MATERIAL PREVENTED THE PASSAGE OF THE VIPERWIRE THROUGH THE OAD. THE ROOT CAUSE OF THE OBSERVED MATERIAL IS UNDER INVESTIGATION. CSI WILL SUBMIT A SUPPLEMENTAL REPORT ONCE THE INVESTIGATION IS COMPLETE. CSI ID: (B)(4).

    Additional Manufacturer Narrative · 0

    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. FOLLOWING OAD ANALYSIS, CSI PERFORMED ANALYSIS AND INVESTIGATION RELATED TO THE PRODUCTION OF THE DEVICE. DURING THIS INVESTIGATION, ATTEMPTS WERE MADE TO CREATE THE EVENT OF FOREIGN PARTICULATE IN THE OAD DRIVESHAFT BUT WERE UNSUCCESSFUL. A REVIEW OF MANUFACTURING PROCESSES AND FINAL FUNCTIONAL TESTS COULD NOT IDENTIFY HOW THE EVENT COULD HAVE OCCURRED DURING THE MANUFACTURING OF THE DEVICE. THEREFORE, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. CSI ID: (B)(4).

    Additional Manufacturer Narrative · 0

    FURTHER INVESTIGATION OF THIS ISSUE DETERMINED THE POTENTIAL RISK IS LOWER THAN INITIALLY ANTICIPATED AND DOES NOT MEET MDR REPORTING CRITERIA AS THE MALFUNCTION IS NOT LIKELY TO LEAD TO DEATH OR SERIOUS INJURY. CSI ID: (B)(4).

    Description of Event or Problem · 0

    DURING AN ATTEMPT TO PASS A VIPERWIRE ADVANCE GUIDE WIRE THROUGH A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD), THE VIPERWIRE COULD NOT PASS THROUGH THE OAD. THE VIPERWIRE APPEARED TO STOP AT THE BRAKE AREA OF THE OAD. NO DAMAGE WAS OBSERVED ON THE VIPERWIRE OR THE OAD. THE OAD WAS EXCHANGED FOR A SECOND OAD, WHICH WAS USED FOR THE PROCEDURE WITH THE SAME VIPERWIRE. THE OAD WHICH DID NOT ALLOW FOR VIPERWIRE PASSAGE WAS RETURNED TO CSI FOR ANALYSIS WHICH IDENTIFIED THE PRESENCE OF MATERIAL WITHIN THE DRIVESHAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2355441 DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM CORONARY ATHERECTOMY DEVICE MCX CARDIOVASCULAR SYSTEMS, INC. DBEC-125 425092-1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown