BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILVERHAWK ATK

    MDR report key: 5544201 · Received April 4, 2016

    Report

    Report Number
    2183870-2016-00294
    Event Type
    Malfunction
    Date Received
    April 4, 2016
    Date of Event
    March 1, 2016
    Report Date
    March 10, 2016
    Manufacturer
    COVIDIEN
    Product Code
    MCW
    PMA / PMN Number
    K061188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PHYSICIAN INSERTED THE SILVERHAWK LX-M THROUGH THE 7F SHEATH WITH DIFFICULTY. FOUR PASSES WERE MADE IN THE SFA. THERE WAS DIFFICULTY REMOVING THE SILVERHAWK FROM THE SHEATH TO CLEAN. THE PHYSICIAN NOTICED A PIECE OF THE NOSE CONE PEELED AWAY NEAR THE CUTTER CHAMBER. AS A RESULT A NEW SILVERHAWK WAS OPENED TO COMPLETE THE PROCEDURE. NO INJURY REPORTED. EVALUATION OF THE RETURNED DEVICE WAS COMPLETED ON MARCH 28, 2016. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT DID NOT REVEAL ANY NON-CONFORMITY RELEVANT TO THIS REPORTED EVENT. THE REPORTED EVENT HAS BEEN CONFIRMED. THE SURFACE OF THE DISTAL ASSEMBLY BENEATH THE CUTTER WINDOW SHOWED THE MATERIAL WAS SLICED/SHAVED. THE STAINLESS STEEL COILS AT THE SEGMENT OF THE DISTAL ASSEMBLY WHERE THE DAMAGE WAS OBSERVED SHOWED SIGNS OF DEFORMATION. THE COILS WERE ELONGATED OR COMPRESSED AT AREAS AROUND/AT THE SHAVED SEGMENT. THE ROOT CAUSE OF THE DAMAGE ENCOUNTERED COULD NOT BE DETERMINED. POSSIBLE CONTRIBUTING FACTORS SUCH AS; LESION MORPHOLOGY, VESSEL ANATOMY, SHEATH INTERACTION, AND PROCEDURAL TECHNIQUE COULD NOT BE EVALUATED IN THIS INVESTIGATION, HOWEVER, ACCORDING TO THE PRODUCT LABELING FOR THE SILVERHAWK LX-M THE RECOMMENDED SHEATH SIZE IS 8F. THE INSTRUCTIONS FOR USES INCLUDES THE FOLLOWING: USE OF SHEATHS SMALLER THAN THOSE RECOMMENDED MAY COMPROMISE DEVICE PERFORMANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200916 SILVERHAWK ATK CATHETER, PERIPHERAL, ATHERECTOMY MCW COVIDIEN P4055 A111789

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR