BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILVERHAWK MS-M

    MDR report key: 5252791 · Received November 27, 2015

    Report

    Report Number
    2183870-2015-00484
    Event Type
    Malfunction
    Date Received
    November 27, 2015
    Date of Event
    December 2, 2014
    Report Date
    December 2, 2014
    Manufacturer
    COVIDIEN
    Product Code
    MCW
    PMA / PMN Number
    K053460
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    EVENT DESCRIPTION: IT WAS REPORTED THAT THE SILVERHAWK WAS SELECTED TO TREAT THE PATIENT'S LEFT DISTAL SFA. A 7F SHEATH WAS USED TO GAIN ACCESS AND A 6MM SPIDER WAS DEPLOYED DISTAL TO THE LESION. THE LESION HAD APPROXIMATELY 90% BLOCKAGE AND WAS 4CM IN LENGTH. THE SILVERHAWK WAS BROUGHT TO THE LESION IN AN ATTEMPT TO DOTTER DOWN BEFORE SHAVING AND IT WOULD NOT CROSS THE LESION. AS THE PHYSICIAN PULLED BACK THE 7F COMPATIBLE DEVICE FROM THE 7F SHEATH, HE EXPERIENCED DIFFICULTY. THE SILVERHAWK COULD NOT BE RETRIEVED THROUGH THE SHEATH AFTER SEVERAL ATTEMPTS. THE PHYSICIAN NEEDED TO PULL THE SHEATH OUT COMPLETELY IN ORDER TO REMOVE THE SILVERHAWK. HE WAS ABLE TO REMOVE THE SILVERHAWK AND SPIDER WITHOUT INJURY TO THE PATIENT; HOWEVER, HE LOST ACCESS IN THIS SCENARIO AND WAS FORCED TO STOP THE CASE. DEVICE EVALUATION: THE DEVICE WAS RECEIVED FOR EVALUATION WITH A SPIDER FX CAPTURE WIRE (REFERENCED IN THE COMPLAINT DESCRIPTION) AND THE GUIDE SHEATH. THE DISTAL TIP ASSEMBLY WAS SEPARATED FROM THE TORQUE SHAFT AT THE ADAPTOR COLLAR BUT REMAINED ATTACHED BY THE DRIVE COIL ASSEMBLY. THE CAPTURE WIRE WAS NOT THREADED THROUGH THE SILVERHAWK'S RX GUIDEWIRE LUMEN. THE CORE OF THE CAPTURE WIRE EXHIBITED SEVERAL BENDS AND A KINK. THE RX GUIDEWIRE LUMEN (GWL) OF THE DEVICE DISTAL TIP EXHIBITED A LONGITUDINAL TEAR THE LENGTH OF THE TIP ASSEMBLY BODY TO THE MARKER BAND. THE GUIDE SHEATH EXHIBITED DEFORMATIONS SUGGESTING THE LONGITUDINAL COMPRESSION (ACCORDION FOLDING) AND THE TIP EXHIBITED TEARS SUGGESTING THAT THE DAMAGED CAPTURE WIRE WAS PULLED AGAINST THE SHEATH EDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782886 SILVERHAWK MS-M CATHETER PERIPHERAL ATHERECTOMY MCW COVIDIEN P4056V02 9692885

    Patients

    Seq Age Sex Outcome Treatment
    1