BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILVERHAWK LX-M

    MDR report key: 5203818 · Received November 5, 2015

    Report

    Report Number
    2183870-2015-00438
    Event Type
    Malfunction
    Date Received
    November 5, 2015
    Date of Event
    September 24, 2013
    Report Date
    September 25, 2013
    Manufacturer
    COVIDIEN
    Product Code
    MCW
    PMA / PMN Number
    K053460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW / REMEDIATION EFFORT PERFORMED AT THE COVIDIEN (B)(4) LOCATION, FOLLOWING MEDTRONIC¿S ACQUISITION OF COVIDIEN. A CAPA HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SLIVERHAWK NOSECONE WAS FOUND TO BE DETACHED FROM CATHETER SHAFT UPON RETRIEVAL. NO PATIENT INJURY REPORTED. DEVICE EVALUATION: THE DISTAL TIP ASSEMBLY WAS SEPARATED FROM THE ADAPTOR COLLAR AT THE HINGE ASSEMBLY. BOTH HINGE PINS WERE PRESENT BUT ONE WAS SIGNIFICANTLY FOLDED IN A PROXIMAL DIRECTION. ONE OF THE HINGE CAVITIES WAS PACKED WITH A GREEN POLYMER RESIDUE THAT WAS CONSISTENT IN APPEARANCE WITH SCRAPED PTFE FROM A COATED GUIDEWIRE OR THE OUTER JACKET OF A GUIDE SHEATH. THERE IS NOTHING INHERENT IN THE SILVERHAWK BILL OF MATERIAL THAT APPEARS SIMILAR TO THE NOTED POLYMER RESIDUE. THE RESIDUE WAS ALSO NOTED IN THE COLLECTED RESIDUE ON THE HOUSING WINDOW AND ON THE OUTSIDE OF THE HOUSING. THE SOURCE AND ACTUAL COMPOSITION OF THE GREEN RESIDUE COULD NOT BE DETERMINED. THE HINGE CAVITIES OF THE SHAFT ADAPTOR EXHIBITED MATERIAL DEFORMATION INDICATING THAT THE HOUSING PINS WERE FORCED TORSIONALLY WITH A BEND BIAS APPROXIMATELY PERPENDICULAR TO THE HINGE TRACK THAT OVERWHELMED THE MATERIAL STRENGTH OF THE HINGE COMPONENTS. THE SOURCE OF THE FORCES COULD NOT BE DETERMINED. THE TIP ASSEMBLY WAS ATTACHED TO THE SILVERHAWK DEVICE BY THE DRIVESHAFT ASSEMBLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735394 SILVERHAWK LX-M CATHETER PERIPHERAL ATHERECTOMY MCW COVIDIEN P4055 9758301

    Patients

    Seq Age Sex Outcome Treatment
    1