BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILVERHAWK MS-M

    MDR report key: 4586746 · Received March 10, 2015

    Report

    Report Number
    2183870-2015-00072
    Event Type
    Malfunction
    Date Received
    March 10, 2015
    Report Date
    February 9, 2015
    Manufacturer
    COVIDIEN
    Product Code
    MCW
    PMA / PMN Number
    K053460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 INFORMATION HAS BEEN REQUESTED. SHOULD IT BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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.

    Description of Event or Problem · 1

    THIS PROCEDURE WAS PERFORMED IN (B)(6). AS REPORTED, THE NOSECONE COULD NOT BE OPENED COULD NOT CUT. NO INJURY TO THE PATIENT. INVESTIGATION OF THE RETURNED DEVICE ON (B)(6) 2015 FOUND CLEAR POLYMER FILM WRAPPED AROUND THE CUTTER HEAD ASSEMBLY STEM. DAMAGE OF A SIMILAR NATURE HAS BEEN OBSERVED WHEN THE SILVERHAWK DISTAL TIP ASSEMBLY IS ADVANCED THROUGH THE GUIDE SHEATH WHILE THE CUTTER HEAD IS IN THE CUTTING ORIENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165178 SILVERHAWK MS-M ATHERECTOMY PERIPHERAL CATHETER MCW COVIDIEN P4056V02 9847075

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other