BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILVERHAWK MS-M

    MDR report key: 5235236 · Received November 19, 2015

    Report

    Report Number
    2183870-2015-00462
    Event Type
    Malfunction
    Date Received
    November 19, 2015
    Date of Event
    March 17, 2015
    Report Date
    March 17, 2015
    Manufacturer
    COVIDIEN
    Product Code
    MCW
    PMA / PMN Number
    K053460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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). INITIAL REPORTER TELEPHONE NUMBER: (B)(6).

    Description of Event or Problem · 1

    EVENT DESCRIPTION: IT WAS REPORTED THAT THE SILVERHAWK HAD TROUBLE CLOSING ITS CUTTER, NO PATIENT INJURY REPORTED. DEVICE EVALUATION: THE CUTTER HEAD WAS LOCATED IN THE DISTAL TIP ASSEMBLY LUMEN. THE THUMBSWITCH WAS PULLED BACK. THE DRIVE SHAFT PROXIMAL TO THE CUTTER HEAD ASSEMBLY (CUTTER AND BLANK) EXHIBITED A WRAPPED SECTION OF A STENT (UNKNOWN MAKE/MODEL). THE ENTANGLING OF THE STENT COMPONENT IN THE TURBOHAWK DRIVE SHAFT PREVENTED THE THUMBSWITCH-DRIVE SHAFT-CUTTER HEAD ASSEMBLY FROM NESTING IN THE HOUSING RAMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766105 SILVERHAWK MS-M CATHETER, PERIPHERAL, ATHERECTOMY MCW COVIDIEN P4056V02 A045487

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR