BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 2590878 · Received May 29, 2012

    Report

    Report Number
    3004742232-2012-00062
    Event Type
    Malfunction
    Date Received
    May 29, 2012
    Date of Event
    April 13, 2012
    Report Date
    May 11, 2012
    Manufacturer
    CARDIOVASCULAR SYSTEMS INCORPORATED
    Product Code
    MCW
    PMA / PMN Number
    K071427
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE OAD WAS RECEIVED WITHOUT THE ORIGINAL SALINE LINE OR GUIDE WIRE. THE INITIAL VISUAL AND TACTILE EXAMINATION OF THE HANDLE ASSEMBLY, SALINE SHEATH AND DRIVESHAFT REVEALED THAT THE DRIVESHAFT CROWN WAS LODGED WITHIN THE DISTAL END OF THE SALINE SHEATH. THE CROWN BOND HAD FAILED AND THE CROWN HAD MIGRATED APPROXIMATELY 5 CENTIMETERS PROXIMALLY FROM THE BOND SITE. THE SALINE SHEATH LENGTH, DRIVESHAFT AND CROWN WERE ALL MEASURED USING A CALIBRATED RULER AND MET THE PRODUCT SPECIFICATIONS. NO OTHER DAMAGE OR ABNORMALITIES WERE OBSERVED WITH THE OAD OR ITS COMPONENTS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE CROWN AND DRIVESHAFT BOND SITE SECTIONS WERE EXAMINED IN A SCANNING ELECTRON MICROSCOPE (SEM). THE DRIVESHAFT BOND SITE EXHIBITED LITTLE SOLDER RESIDUE ON THE SURFACE OF THE FILARS. AT THE CONCLUSION OF THE FAILURE ANALYSIS INVESTIGATION, THE ROOT CAUSE OF THE REPORTED EVENT IS AN INADEQUATE CROWN SOLDER BOND. 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. ADDITIONAL INVESTIGATION AND CORRECTIVE ACTIONS HAVE BEEN INITIATED TO PREVENT THE RECURRENCE OF THIS TYPE OF EVENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED PER THE ATTACHED FACILITY MEDWATCH: "EVENT DESC: THE CROWN BURROWED ITS WAY INTO A PROTECTIVE COVERING, PLASTIC CATHETER OVER IT. IT WAS NOT TRACKING THE WAY THE PHYSICIAN WAS DIRECTING THE CATHETER. IT APPEARED THAT THE WELD HAD BROKEN OVER THE DIAMOND; NOT SPINNING OR ADVANCING AS IT SHOULD. IT WAS NOT ATHERECTOMIZING THE VESSEL AS IT SHOULD. WHAT WAS THE ORIGINAL INTENDED PROCEDURE: ORBITAL ATHERECTOMY OF THE RIGHT ANTERIOR TIBIAL/POSTERIOR TIBIAL ARTERY WITH A 1.25 DIAMONDBACK CARDIOVASCULAR SYSTEMS, INC. (CSI). DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO OTHER THERAPIES IN USE ON PATIENT: NOT KNOWN ETHNIC BACKGROUND: UNKNOWN OTHER PERTINENT INFO: PERIPHERAL VASCULAR DISEASE - TORTUOUS VESSELS." THE LESION BEING TREATED WAS MODERATELY CALCIFIED, 90% STENOTIC, 8CM IN LENGTH, AND EXTENDED FROM THE DISTAL POPLITEAL (POP) INTO THE PROXIMAL ANTERIOR TIBIAL (AT) ARTERY. THE PHYSICIAN USED A 6F INTRODUCER SHEATH FROM AN ANTEGRADE APPROACH TO ACCESS THE TARGET LESION. THE PHYSICIAN SUCCESSFULLY SPUN 5 RUNS IN THE POSTERIOR TIBIAL (PT) ARTERY AND THEN 2 RUNS IN THE POP/AT FOR A TOTAL RUN TIME OF 3.5 MINS WITH THIS DEVICE PRIOR TO THE REPORTED MALFUNCTION. THE CROWN REMAINED INSIDE THE SALINE SHEATH AND EVERYTHING WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT. THE PHYSICIAN OPENED A 1.25 OAD AND COMPLETED THE CASE WITHOUT INCIDENT. THE PATIENT STATUS REMAINED STABLE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM MCW MCW CARDIOVASCULAR SYSTEMS INCORPORATED PRD-SC30-125S 59887

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR