BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILVERHAWK LX-M

    MDR report key: 5242145 · Received November 23, 2015

    Report

    Report Number
    2183870-2015-00469
    Event Type
    Malfunction
    Date Received
    November 23, 2015
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    PLYMOUTH
    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

    THE PHYSICIAN USED A SILVERHAWK DURING PROCEDURE. IT IS REPORTED THAT TISSUE WAS COLLECTED. IN STENT STENOSIS AND NO TORTUOSITY WAS REPORTED. IT IS REPORTED THAT AS THE DEVICE WAS BEING WITHDRAWN FROM THE PATIENT, THE NOSECONE SEPARATED. EVALUATION SUMMARY: THE SILVERHAWK DEVICE WAS RECEIVED FOR EVALUATION WITH THE CUTTER DRIVER BUT WITHOUT OTHER ANCILLARY DEVICES OR CINE IMAGES FROM THE PROCEDURE. THE DISTAL TIP ASSEMBLY EXHIBITED A SEPARATION BETWEEN THE HOUSING AND THE COLLAR ADAPTOR (HINGE SEPARATION). BOTH HINGE PINS WERE PRESENT BUT THE HOUSING SLEEVE OVER ONE OF THE PINS EXHIBITED SIGNIFICANT MATERIAL DEFORMATION. THE OTHER SIDE OF THE HOUSING AND ITS PIN WERE RELATIVELY UNDAMAGED. THE HINGE PIN CAVITIES EXHIBITED MATERIAL DEFORMATION WITH A PROXIMAL BIAS ON ONE SIDE AND A DISTAL BIAS ON THE OTHER SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775202 SILVERHAWK LX-M CATHETER, PERIPHERAL, ATHERECTOMY MCW PLYMOUTH P4055 9712190

    Patients

    Seq Age Sex Outcome Treatment
    1