BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIPERWIRE, ADVANCE

    MDR report key: 22349658 · Received June 27, 2025

    Report

    Report Number
    3004742232-2025-00181
    Event Type
    Malfunction
    Date Received
    June 27, 2025
    Date of Event
    May 7, 2025
    Report Date
    June 27, 2025
    Manufacturer
    CARDIOVASCULAR SYSTEMS INCORPORATED
    Product Code
    MCW
    PMA / PMN Number
    K180416
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED DIFFICULT TO REMOVE WAS CONFIRMED. A CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. THE PRODUCTION RECORDS FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR COMPLAINT QUERY COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT REPORTED, AND THE PACKAGING WAS NOT RETURNED. BASED ON THE REPORTED INFORMATION AND THE OBSERVATIONS FROM THE RETURNED ANALYSIS, THE INVESTIGATION DETERMINED THAT THE REPORTED DIFFICULT TO REMOVE APPEARS TO BE RELATED TO USER ERROR. DESTRUCTIVE ANALYSIS OF THE DRIVESHAFT REVEALED A SPRING TIP FILAR FRAGMENT LODGED UNDER THE DRIVESHAFT. THE DAMAGED/FRACTURED SPRING TIP INDICATE THAT THE SPINNING OAD DRIVESHAFT MADE CONTACT WITH THE SPRING TIP. THE DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM INSTRUCTIONS FOR USE (IFU) 92-10017 REVISION C), WARNS: ¿NEVER ADVANCE THE ORBITING CROWN TO THE POINT OF CONTACT WITH THE GUIDE WIRE SPRING TIP OR OTHER DISTAL DEVICE. THE MAXIMUM TRAVEL OF THE CROWN ADVANCER KNOB¿AND THEREFORE THE SHAFT TIP¿IS 15 CM. MOVING THE CROWN ADVANCER KNOB FORWARD MOVES THE SHAFT TIP AN EQUAL DISTANCE TOWARD THE GUIDE WIRE SPRING TIP. WHEN MOVING THE CROWN ADVANCER KNOB, MAKE SURE THERE IS SUFFICIENT DISTANCE BETWEEN THE GUIDE WIRE SPRING TIP (OR OTHER DISTAL DEVICE) AND THE DISTAL END OF THE SHAFT (10 CM MINIMUM). IF THE DISTANCE BETWEEN THE SHAFT TIP AND THE GUIDE WIRE SPRING TIP (OR OTHER DISTAL DEVICE) IS INSUFFICIENT, THE SHAFT TIP MAY DAMAGE THE GUIDE WIRE SPRING TIP (OR OTHER DISTAL DEVICE) AND RESULT IN DEVICE OR COMPONENT DISLODGEMENT. DISTAL DETACHMENT AND EMBOLIZATION MAY RESULT.¿ BASED ON THE RESULTS OF THE COMPLAINT INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 0

    FOLLOWING LOW SPEED AND MEDIUM SPEED TREATMENTS, IN A HEAVILY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY, THE STEALTH 360 ORBITAL ATHERECTOMY DEVICE (OAD) STOPPED SPINNING. THE OAD BECAME STUCK ON THE VIPERWIRE ADVANCE PERIPHERAL GUIDE WIRE. THE OAD AND WIRE WERE REMOVED TOGETHER. DURING REMOVAL, THE OAD FELT WARM. THE OAD WAS SPUN EX VIVO AND THE OAD WAS REPORTED TO BE HOT TO THE TOUCH. AN ATTEMPT WAS MADE TO SEPARATE THE OAD AND GUIDE WIRE BUT WAS UNSUCCESSFUL. THE PATIENT WAS STABLE WITH NO ADVERSE EFFECTS. THE WIRE WAS RETURNED ENGAGED IN THE DEVICE. DURING DEVICE ANALYSIS, RESISTANCE WAS OBSERVED WHEN ATTEMPTING TO REMOVE THE WIRE FROM THE DEVICE. FURTHER ANALYSIS REVEALED SPRING TIP COIL MATERIAL WITHIN THE DRIVESHAFT WHICH INDICATED A GUIDE WIRE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004133 VIPERWIRE, ADVANCE CATHETER, PERIPHERAL, ATHERECTOMY MCW CARDIOVASCULAR SYSTEMS INCORPORATED VPR-GW-14

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female