BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLOSUREFAST CATHETER, 7F, 60CM

    MDR report key: 3813627 · Received May 15, 2014

    Report

    Report Number
    2183870-2014-00101
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    PMA / PMN Number
    K111887
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY 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 (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

    AS REPORTED THE CUSTOMER STATED, "THE HEATING COIL WAS BENT. THE CATHETER WAS IN THE PATIENT AND THE GENERATOR INDICATED THE TEMPERATURE WAS HIGH." INVESTIGATION OF THE RETURNED CLOSUREFAST ON (B)(6) 2014 FOUND A KINK AND DAMAGE TO THE FEP COATING OF THE COIL APPROXIMATELY 3CM FROM THE DISTAL TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291122 CLOSUREFAST CATHETER, 7F, 60CM ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN CF7-3-60 552347

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other