BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 10322353 · Received July 24, 2020

    Report

    Report Number
    3004742232-2020-00214
    Event Type
    Malfunction
    Date Received
    July 24, 2020
    Date of Event
    July 2, 2020
    Report Date
    July 24, 2020
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCX
    UDI-DI
    10850000491356
    PMA / PMN Number
    P130005
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE OAD AND GUIDE WIRE WERE RECEIVED FOR ANALYSIS. THE OAD AND GUIDE WIRE WERE ENGAGED. THE OAD DRIVESHAFT NEAR THE CROWN WAS DAMAGED, STRETCHED, AND DEFORMED. TWO FILAR FRACTURES WERE OBSERVED. THE OAD FUNCTIONED AS INTENDED DURING TESTING. THE GUIDE WIRE WAS A PERIPHERAL GUIDE WIRE, WHICH IS NOT INDICATED FOR USE WITH A CORONARY OAD. THE SPRING TIP OF THE GUIDE WIRE WAS DAMAGED AND DEFORMED. THERE WAS A FRACTURE IN THE SPRING TIP COIL. DURING THE INVESTIGATION, HOSPITAL STAFF STATED THAT NEITHER CSI COMPONENT HAD FRACTURED IN VIVO. THE STAFF ALSO STATED A TOOL WAS USED IN AN ATTEMPT TO DISENGAGE THE WIRE AND OAD. THEREFORE, THE DAMAGED DRIVESHAFT AND GUIDEWIRE SPRING TIP ARE LIKELY DUE TO REMOVAL ATTEMPTS OF THE WIRE FROM THE DRIVESHAFT. AT THE CONCLUSION OF THE DEVICE ANALYSIS, THE REPORTED EVENT (THAT THE OAD BECAME STUCK ON THE GUIDE WIRE) WAS CONFIRMED, AND THE ROOT CAUSE WAS THE USE OF AN INCOMPATIBLE GUIDE WIRE. THE DIAMONDBACK 360® CORONARY ORBITAL ATHERECTOMY SYSTEM INSTRUCTIONS FOR USE 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 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. CSI ID# (B)(4).

    Description of Event or Problem · 1

    A DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR TREATMENT OF A HEAVILY CALCIFIED LESION IN THE CIRCUMFLEX ARTERY AND OSTIAL MEDIAL ARTERY. THE PERIPHERAL VIPERWIRE GUIDE WIRE WAS PLACED AT THE LESION, AND THE OAD WAS ADVANCED OVER THE WIRE. HOWEVER, THE OAD BECAME STUCK ON THE GUIDE WIRE THE PATIENT EX VIVO. THE GUIDE WIRE WAS REMOVED FROM THE PATIENT WITH THE OAD REMAINING ON THE PROXIMAL END. THE USER ATTEMPTED TO DISENGAGE THE GUIDE WIRE AND OAD BY HAND AND WITH A TOOL EX VIVO. THE PROCEDURE WAS ABORTED, AND ADDITIONAL TREATMENT WAS CONSIDERED FOR THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785232 DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM CORONARY ATHERECTOMY DEVICE MCX CARDIOVASCULAR SYSTEMS, INC. DBEC-125 318250 10850000491356

    Patients

    Seq Age Sex Outcome Treatment
    1