BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILVERHAWK LX-M

    MDR report key: 5252826 · Received November 27, 2015

    Report

    Report Number
    2183870-2015-00485
    Event Type
    Malfunction
    Date Received
    November 27, 2015
    Date of Event
    February 17, 2015
    Report Date
    February 18, 2015
    Manufacturer
    PLYMOUTH
    Product Code
    MCW
    PMA / PMN Number
    K053460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. INITIAL REPORTER TELEPHONE: (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT AFTER SEVERAL PASSAGES AND CLEANING OF THE NOSECONE, THE CUTTER BLADE WOULD NOT ADVANCE INTO THE NOSECONE. A SILVERHAWK WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY IS REPORTED. EVALUATION SUMMARY: THE SILVERHAWK DEVICE WAS RECEIVED FOR EVALUATION WITHOUT THE CUTTER DRIVER OR ANY OTHER ANCILLARY DEVICES OR CINE IMAGES FROM THE PROCEDURE. THE CUTTER HEAD ASSEMBLY WAS NESTED IN THE HOUSING RAMP. THE CUTTER BLADE EXHIBITED SEVERAL CHIPS . THE CUTTER HEAD ASSEMBLY WAS ABLE TO ADVANCE INTO THE DISTAL TIP ASSEMBLY LUMEN BUT THE BLADE WOULD ONLY ADVANCE TO APPROXIMATELY THE JOINT BETWEEN THE HOUSING COIL AND THE STAINLESS STEEL COIL. THERE WAS AN ACCUMULATION OF A TRANSLUCENT/ CLEAR POLYMER IMMEDIATELY DISTAL TO THE PLUNGER. THE PLUNGER WAS PUSHED TO THE HOUSING WINDOW BUT THE POLYMER WOULD NOT ENTER THE WINDOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783011 SILVERHAWK LX-M CATHETER, PERIPHERAL, ATHERECTOMY MCW PLYMOUTH P4055V02 A010047

    Patients

    Seq Age Sex Outcome Treatment
    1