BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILVERHAWK MS-M

    MDR report key: 4743167 · Received May 1, 2015

    Report

    Report Number
    2183870-2015-00171
    Event Type
    Injury
    Date Received
    May 1, 2015
    Date of Event
    March 9, 2015
    Report Date
    April 23, 2015
    Manufacturer
    COVIDIEN
    Product Code
    MCW
    PMA / PMN Number
    K053460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT. (B)(4).

    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

    THIS IN-STENT RESTENOSIS PROCEDURE WAS PERFORMED IN (B)(6). AS REPORTED, THE SILVERHAWK COULD NOT BE CLEANED. THE PROCEDURE WAS COMPLETED WITH A SECOND DEVICE. EVALUATION OF THE RETURNED DEVICE ON (B)(6) 2015 FOUND FRAGMENTS FROM A STENT PROXIMAL TO THE CUTTER HEAD WHICH WOULD HINDER THE PROXIMAL MOVEMENT OF THE CUTTER HEAD. THE STENT FRAGMENTS WERE REMOVED PROXIMALLY FROM THE CUTTER HEAD AND THE CUTTER HEAD WAS THEN ABLE TO BE ADVANCED INTO THE CUTTER WINDOW AND ONTO THE RAMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287417 SILVERHAWK MS-M ATHERECTOMY PERIPHERAL CATHETER MCW COVIDIEN P4056 9975292

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other