BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 10089273 · Received May 26, 2020

    Report

    Report Number
    3004742232-2020-00146
    Event Type
    Malfunction
    Date Received
    May 26, 2020
    Date of Event
    April 30, 2020
    Report Date
    June 15, 2020
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCW
    PMA / PMN Number
    K190634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED OAS PUMP AND TWO OADS WERE RECEIVED FOR ANALYSIS. NO VISIBLE DAMAGE WAS OBSERVED ON ANY DEVICE. A GUIDE WIRE PASSED THROUGH EACH OF THE OADS WITH NO RESISTANCE. THE RETURNED OAS PUMP WAS TESTED, AND THE PUMP FUNCTIONED AS INTENDED WITH NO ABNORMALITIES. DIAGNOSTIC ANALYSIS WAS PERFORMED AND DID NOT REVEAL ANY ISSUES WITH THE PUMP OR IT'S COMPONENTS. THE FIRST OAD WAS TESTED USING THE RETURNED OAS PUMP AND FUNCTIONED AS INTENDED. THE SECOND OAD WAS TESTED USING THE RETURNED OAS PUMP. WHEN POWER WAS APPLIED, THE PUMP WOULD INCREASE TO HIGH SPEED WITHOUT ACTIVATING THE OAD, AND THE OAD DID NOT SPIN. THE OAD WAS ALSO TESTED USING A DIFFERENT PUMP, AND THE SAME ISSUE OCCURRED. ELECTRICAL ANALYSIS WAS PERFORMED AND DID NOT REVEAL ANY ISSUES WITH THE OAD. THE OAD WAS THEN RE-TESTED WITH THE RETURNED PUMP AND THE SECOND PUMP AND WAS FOUND TO SPIN BOTH TIMES AS EXPECTED WITH NO ABNORMALITIES OBSERVED. THE NOTED ISSUE WAS DETERMINED TO BE AN INTERMITTENT ISSUE. THE INTERMITTENT FAILURE MAY BE DUE TO A DAMAGED PCBA COMPONENT. HOWEVER, SINCE THE FAILURE WAS INTERMITTENT AND DID NOT REOCCUR DURING ELECTRICAL ANALYSIS, THE EXACT CAUSE OF PCBA ISSUE COULD NOT BE DETERMINED. AT THE CONCLUSION OF THE DEVICE ANALYSIS, THE REPORTED COMPLAINT OF THE OADS STOPPING WERE UNABLE TO BE CONCLUSIVELY CONFIRMED. THE DEVICE HISTORY RECORD FOR THE LOT NUMBERS OF THESE THREE DEVICES HAVE BEEN REVIEWED. NO ISSUES OR DISCREPANCIES WERE NOTED DURING THIS REVIEW THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DEVICES MET MATERIAL, ASSEMBLY, AND QUALITY CONTROL REQUIREMENTS. D4: AS NO OAS PUMP FAILURE WAS IDENTIFIED DURING PRODUCT ANALYSIS, PRODUCT UPDATED TO THE OAD ON WHICH A FAILURE WAS FOUND. CSI ID#: (B)(4).

    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

    A PROCEDURE WAS PERFORMED TO TREAT A HIGH GRADE 90% STENOSED PERIPHERAL LESION IN THE PERONEAL ARTERY. A STEALTH PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED WITH AN OAS PUMP, HOWEVER, THE OAD STOPPED SPINNING AFTER ONE SECOND. THE OAD WAS REMOVED AND REPLACED WITH A DIAMONDBACK PERIPHERAL OAD. HOWEVER, THE ISSUE RECURRED, AND THE SECOND OAD STOPPED SPINNING AFTER ONE SECOND. THE PHYSICIAN STATED THE OADS WERE NOT STUCK IN THE LESION, AND THE ISSUE WAS THOUGHT TO BE DUE TO THE PUMP. IT WAS NOTED THAT THE OAS PUMP WAS NOT WORKING AS INTENDED AND THE LIGHTS SWITCHED FROM GREEN TO YELLOW DURING EACH INSTANCE. THE PROCEDURE WAS DELAYED BY GREATER THAN 30 MINUTES, AND THE PROCEDURE WAS COMPLETED WITH ALTERNATE THERAPY. THE PATIENT WAS HEALTHY FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553318 DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY DEVICE MCW CARDIOVASCULAR SYSTEMS, INC. DBP-125MICRO145 226528

    Patients

    Seq Age Sex Outcome Treatment
    1