BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILVERHAWK BTK

    MDR report key: 5498592 · Received March 14, 2016

    Report

    Report Number
    2183870-2016-00249
    Event Type
    Malfunction
    Date Received
    March 14, 2016
    Date of Event
    May 12, 2015
    Report Date
    May 14, 2015
    Manufacturer
    COVIDIEN
    Product Code
    MCW
    PMA / PMN Number
    K053460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 IS REPORTED THAT THE DEVICE WOULD NOT PASS WHEN PUSHED THROUGH THE LESION AND WHEN THE DEVICE WAS BROUGHT OUT AND THE LESION WAS PRE DILATED IT WAS NOTICED THAT THE DISTAL TIP WAS SPLIT. THE PHYSICIAN ALSO NOTED A KINK NEAR THE HUB SO REMOVED THE DEVICE AND COMPLETED THE PROCEDURE WITH A NEW DEVICE. NO PATIENT INJURY IS REPORTED. EVALUATION SUMMARY: THE SILVERHAWK DEVICE WAS RECEIVED FOR EVALUATION WITHOUT THE CUTTER DRIVER (ATTACHED) OR ANY OTHER ANCILLARY DEVICES. THE DISTAL TIP ASSEMBLY HOUSING EXHIBITED ASYMMETRICAL DEFORMATION THAT COULD HAVE BEEN EITHER PRESENT DURING THE PROCEDURE OR GENERATED POST-PROCEDURE. THE POLYIMIDE GUIDEWIRE LUMEN (GWL) WAS FRACTURED AT THE DISTAL EDGE OF THE TIP ASSEMBLY HOUSING. THE GWL PROXIMAL TO THE FRACTURE SITE EXHIBITED A LONGITUDINAL TEAR FROM THE PROXIMAL EDGE TO THE FRACTURE. THE GWL DISTAL TO THE FRACTURE HAD PEELED FROM THE TECOTHANE JACKET UNTIL THE GWL WAS INCORPORATED DEEP ENOUGH INTO THE TECOTHANE TAPERED TIP TO STOP THE DAMAGE. THE WHITE TORQUE SHAFT SLEEVE WAS FULLY INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155606 SILVERHAWK BTK CATHETER, PERIPHERAL, ATHERECTOMY MCW COVIDIEN P4028 A064593

    Patients

    Seq Age Sex Outcome Treatment
    1