BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 11563116 · Received March 24, 2021

    Report

    Report Number
    3004742232-2021-00091
    Event Type
    Injury
    Date Received
    March 24, 2021
    Date of Event
    February 26, 2021
    Report Date
    March 26, 2021
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCX
    UDI-DI
    30852528005187
    PMA / PMN Number
    P130005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: THE GUIDE WIRE WAS RETURNED FOR ANALYSIS ALONG WITH THE OAD USED DURING THE PROCEDURE. THE GUIDE WIRE WAS CONFIRMED TO BE FRACTURED AND THE WIRE SPRING TIP WAS NOT RETURNED. THERE WAS ADHERED BIOLOGICAL MATERIAL ON THE CORE WIRE. THE EXACT CAUSE AND MORPHOLOGY OF THE MATERIAL IS UNKNOWN. EXAMINATION IN THE AREA DID NOT REVEAL ANY DAMAGE THAT WOULD HAVE CONTRIBUTED TO THE ACCUMULATION. SCANNING ELECTRON MICROSCOPY ANALYSIS OF THE SPRING TIP FRACTURE FACE SHOWED EVIDENCE OF TORSION. IT IS HYPOTHESIZED THAT THE SPINNING OAD DRIVESHAFT MADE CONTACT WITH THE GUIDE WIRE SPRING TIP CAUSING THE DAMAGE. THIS IS CONSISTENT WITH THE EVENT DETAILS WHICH STATE "THE CROWN JUMPED FORWARD AND BECAME STUCK ON THE VIPERWIRE GUIDE WIRE". AT THE CONCLUSION OF THE DEVICE ANALYSIS INVESTIGATION, THE ROOT CAUSE OF THE EVENT IS CONSIDERED USER ERROR. THE INSTRUCTIONS FOR USE FOR THE CORONARY OAS WARN: DO NOT COME WITHIN 5 MM OF THE PROXIMAL END OF THE VIPERWIRE GUIDE WIRE SPRING TIP WITH THE DISTAL END OF THE OAD DRIVE SHAFT. IF THE DISTANCE BETWEEN THE SHAFT TIP AND THE VIPERWIRE GUIDE WIRE SPRING TIP IS INSUFFICIENT, THE SHAFT TIP MAY CONTACT THE GUIDE WIRE SPRING TIP AND RESULT IN DISLODGING THE GUIDE WIRE SPRING TIP. USE FLUOROSCOPY TO MONITOR MOVEMENT OF THE SHAFT TIP IN RELATION TO THE VIPERWIRE GUIDE WIRE SPRING TIP. 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 PRIOR TO DISTRIBUTION. CSI ID: 09807

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE REPORTED DEVICE IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    WHEN THE DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS ACTIVATED IN THE CIRCUMFLEX, THE CROWN JUMPED FORWARD AND BECAME STUCK ON THE VIPERWIRE GUIDE WIRE. DURING ATTEMPTS TO REMOVE THE OAD BY PULLING IT BACKWARDS, THE TIP OF THE VIPERWIRE BECAME DETACHED. THE WIRE FRAGMENT WAS UNABLE TO BE REMOVED AND REMAINED IN THE PATIENT. THE PROCEDURE WAS CONTINUED WITH BALLOON ANGIOPLASTY AND STENT PLACEMENT, AND THE PATIENT WAS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457590 DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM CORONARY ATHERECTOMY DEVICE MCX CARDIOVASCULAR SYSTEMS, INC. GWC-12325LG-FLP 11144567 30852528005187

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other