BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRELLIS 6 120X30

    MDR report key: 3955805 · Received July 24, 2014

    Report

    Report Number
    2183870-2014-00187
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    COVIDIEN
    Product Code
    KRA
    PMA / PMN Number
    K130904
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 (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

    THE PROXIMAL BALLOON OF THE TRELLIS BURST. THE DEVICE WAS REMOVED AND ANOTHER TRELLIS WAS INSERTED. ADDITIONAL INFORMATION IN THE PROCEDURE REPORT RECEIVED (B)(4) 2014 FOUND THAT THE PROCEDURE WAS PERFORMED ON THE LEFT LEG. PER THE PROCEDURE REPORT THE PHYSICIAN OVER INFLATED THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434178 TRELLIS 6 120X30 CATHETER, CONTINUOUS FLUSH KRA COVIDIEN BVT612030 552071

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other