BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILVERHAWK LX-M

    MDR report key: 5242115 · Received November 23, 2015

    Report

    Report Number
    2183870-2015-00467
    Event Type
    Malfunction
    Date Received
    November 23, 2015
    Date of Event
    July 24, 2014
    Report Date
    July 21, 2014
    Manufacturer
    PLYMOUTH
    Product Code
    MCW
    PMA / PMN Number
    K053460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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.

    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 PHYSICIAN USED THE DEVICE TO TREAT IN STENT RESTENOSIS IN THE RIGHT SFA. WHEN ADVANCING DEVICE INTO STENOSED AREA WITHIN THE STENT RESISTANCE WAS MET. A FEW ATTEMPTS TO TURN THUMB SWITCH OFF WERE MADE BUT CUTTER SEEMED "CAUGHT" AND WOULD NOT ADVANCE INTO NOSE CONE. THE PHYSICIAN THEN SLIGHTLY PULLED BACK DEVICE AND ROTATED CUTTER. THIS ALLOWED THE DEVICE TO ADVANCE WITHOUT RESISTANCE. THE DEVICE WAS REMOVED TO CLEAN. THE TECH WAS NOT ABLE TO GET THE THUMB SWITCH TO PULL BACK INTO THE "ON" OR OPEN POSITION FOR PROPER CLEANING. A NEW DEVICE WAS OPENED TO FINISH TREATING. NO PATIENT INJURY IS REPORTED. DEVICE EVALUATION: THE SILVERHAWK DEVICE WAS RECEIVED FOR EVALUATION WITHOUT ANY ANCILLARY DEVICES OR CINE IMAGES FROM THE PROCEDURE. THE CUTTER HEAD ASSEMBLY WAS LOCATED FULLY WITHIN THE DISTAL TIP ASSEMBLY AS DEFINED BY THE THUMBSWITCH TRAVEL. THERE WAS SOME DRIED BLOOD IN THE TIP ASSEMBLY WINDOW . THE THUMBSWITCH WAS PULLED BACK AND THE CUTTER HEAD ASSEMBLY NESTED IN THE HOUSING RAMP. THE CUTTER BLADE EXHIBITED A CHIP AND THE EDGE OF THE HOUSING WINDOW EXHIBITED A CUT IN THE DISTAL WALL. THE INNER WALL OF THE HOUSING EXHIBITED A DEFORMATION AND SHAVING OF THE HOUSING WALL CORRESPONDING WITH THE NOTED WALL-CUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772810 SILVERHAWK LX-M CATHETER, PERIPHERAL, ATHERECTOMY MCW PLYMOUTH P4055V02 9872594

    Patients

    Seq Age Sex Outcome Treatment
    1