BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILVERHAWK MS-M

    MDR report key: 4466195 · Received January 29, 2015

    Report

    Report Number
    2183870-2015-00025
    Event Type
    Injury
    Date Received
    January 29, 2015
    Date of Event
    December 29, 2014
    Report Date
    December 30, 2014
    Manufacturer
    COVIDIEN
    Product Code
    MCW
    PMA / PMN Number
    K053460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW / REMEDIATION EFFORT PERFORMED AT THE COVIDIEN PLYMOUTH 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.

    Description of Event or Problem · 1

    THE PROCEDURE WAS AN INTERVENTION ON THE LEFT SFA VIA ACCESS FROM THE RIGHT SFA. THE PATIENT HAS A VERY STEEP AORTIC BIFURCATION. THE PHYSICIAN USED A 7F SHEATH. DUE TO THE STEEP BIFURCATION THE PHYSICIAN WAS ONLY ABLE TO ADVANCE THE SHEATH TO THE DISTAL EXTERNAL ILIAC. AN 014 WIRE WAS ADVANCED TO THE LEFT BTK. THE SILVERHAWK MSM WAS ADVANCED OVER THE WIRE TO THE DISTAL SFA. THE PHYSICIAN WAS HAVING DIFFICULTY TORQUING THE NOSECONE DUE TO THE AORTIC BIFURCATION. FOUR PASSES WERE MADE. AS THE PHYSICIAN WAS TAKING THE SILVERHAWK MSM OUT OF BODY TO TAKE AN ANGIO, THE DEVICE BECAME STUCK INSIDE SHEATH. THE PHYSICIAN WAS UNABLE TO TAKE THE DEVICE OUT WITHOUT TAKING THE WIRE AND SHEATH OUT WITH IT. AS A RESULT, THE PHYSICIAN REMOVED THE SILVERHAWK, WIRE, AND SHEATH. THE FORCE THE PHYSICIAN USED TRYING TO REMOVE THE DEVICE OUT OF BODY CAUSED THE NOSECONE ON THE SILVERHAWK TO SEPARATE. THE PHYSICIAN PLACED ANOTHER SHORT SHEATH IN TO TAKE AN ANGIO OF THE LEFT SFA. THE LESION LOOKED BETTER BUT COULD USE ADDITIONAL ATHERECTOMY. THE PHYSICIAN DECIDED TO END THE CASE AND BRING PATIENT BACK FOR AN ANTEGRADE STICK.

    Description of Event or Problem · 1

    DEVICE EVALUATION: THE SILVERHAWK DISTAL TIP ASSEMBLY WAS SEPARATED AT THE HOUSING-ADAPTOR COLLAR HINGE. THE TWO COMPONENTS WERE CONNECTED BY THE DRIVE COIL AND WERE NOT DETACHED FROM THE SILVERHAWK DEVICE. THE DEFORMATION OF THE HINGE PINS INDICATE A DUCTILE DEFORMATION CAUSED BY TENSILE FORCES. THE DISTAL EDGE OF THE GUIDE SHEATH EXHIBITED MATERIAL DEFORMATION CONSISTENT WITH LONGITUDINALLY COMPRESSIVE INTERACTION WITH A PROLAPSED GUIDEWIRE. THE BODY OF THE GUIDE SHEATH ALSO EXHIBITED LONGITUDINAL COMPRESSIONS (BUCKLING) INDICATING LONGITUDINAL FORCES EXCEEDING THE SHEATH COLUMN STRENGTH. THE GUIDEWIRE EXHIBITED SEVERAL BENDS SUGGESTING PROLAPSE FOLDING. THE SILVERHAWK GUIDEWIRE LUMEN DID NOT EXHIBIT ANY LONGITUDINAL TEARING BUT SOME OF THE BENDS NOTED ON THE GUIDEWIRE WOULD HAVE TORN THE GUIDEWIRE LUMEN HAD IT PASSED THROUGH IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67207 SILVERHAWK MS-M ATHERECTOMY PERIPHERAL CATHETER MCW COVIDIEN P4056V02 9953952

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other