BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 1872890 · Received September 29, 2010

    Report

    Report Number
    3004742232-2010-00016
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    August 20, 2010
    Report Date
    August 31, 2010
    Manufacturer
    CARDIOVASCULAR SYSTEMS INCORPORATED
    Product Code
    MCW
    PMA / PMN Number
    K071427
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE DEVICE IS CURRENTLY RETAINED BY THE FACILITY; THEREFORE, A DEVICE ANALYSIS CANNOT BE PERFORMED AT THIS TIME. THE MATERIAL INSPECTION RECORD 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 COMPLAINT. THE DEVICE MET ITS MATERIAL, ASSEMBLY, AND QUALITY CONTROL REQUIREMENTS. THE ROOT CAUSE FOR THE REPORTED EVENT IS UNKNOWN. (B)(4). ADDITIONAL INFORMATION FROM THE IMPORTER REPORT: (B)(4): CARDIOVASCULAR SYSTEMS INC (CSI), VIPER WIRE ADVANCE GUIDEWIRE, (B)(4).

    Description of Event or Problem · 1

    PER THE ATTACHED FACILITY MEDWATCH REPORT# (B)(4) RECEIVED FROM THE FACILITY- REPORTING PRODUCT PROBLEM WITH NO PATIENT INJURY: "DURING PTCA ATHERECTOMY WAS PERFORMED AFTER EXCHANGING THE 1.25 MM BURR TO 2.25 OF MM BURR AT THE LEVEL OF THE DISTAL SUPERFICIAL FEMORAL ARTERY TO ITS CALCIFIC SEGMENT. THE PATIENT WAS ALSO NOTED TO HAVE THE DISTAL TIP OF THE VIPER WIRE DISLODGED AT THE LEVEL OF THE ANTERIOR TIBIAL SEGMENT. SUBSEQUENTLY, THE DEVICE WAS RETRIEVED WITH AND 6 FRENCH MULTIPURPOSE CATHETER WAS SELECTIVELY PLACED AT THE LEVEL OF THE BROKEN TIP OF THE WIRE AND ASPIRATION DONE THROUGH THIS CATHETER TO RETRIEVE THE DISTAL TIP OF THE WIRE WITH POST ANGIOGRAPHIC VIEWS SHOWING PRESERVED FLOW AT THE LEVEL OF THE TIBIOPERONEAL TRUNK AND PERONEAL ARTERY. NO HARM TO PATIENT." PLEASE NOTE THAT THE DESCRIPTION PROVIDED ABOVE BY THE FACILITY STATES, "DURING PTCA ATHERECTOMY..." HOWEVER, THIS WAS A PERIPHERAL ATHERECTOMY PROCEDURE RATHER THAN A CORONARY ATHERECTOMY PROCEDURE AND SHOULD HAVE BEEN DESCRIBED AS A PTA ATHERECTOMY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM MCW CARDIOVASCULAR SYSTEMS INCORPORATED VPR-GW-14 35042

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other