BEUDAMED
    FDA Adverse Event Injury Summary report: N

    U-CLIP SUTURE DEVICE

    MDR report key: 1624838 · Received March 3, 2010

    Report

    Report Number
    2135394-2010-00004
    Event Type
    Injury
    Date Received
    March 3, 2010
    Date of Event
    February 2, 2010
    Report Date
    February 2, 2010
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    FZP
    PMA / PMN Number
    K053252
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LAB, VISUAL INSPECTION OF TWO INTACT RELEASE MEMBERS REVEALED MARKS ON THE INTACT RELEASE ASSEMBLIES THAT APPEARED TO BE GRASPED WITH SIGNIFICANT FORCE. IF GRASPED IN THIS AREA FIRMLY OR WITH AN INSTRUMENT WITH SHARP EDGES, IT IS LIKELY THAT THE CORE WIRE RUNNING THROUGH THE ASSEMBLY MAY BE FRACTURED. THE REMNANT FROM A THIRD RELEASE MEMBER WHEN ALIGNED WITH THE LOCATION OF THE GRASP AREA ON THE INTACT RELEASE MEMBERS DEMONSTRATED THAT THE GRASPING TECHNIQUE CAUSED THE CORE WIRE OF THE RELEASE MEMBER TO FRACTURE. THE FOURTH RELEASE MEMBER COMPONENTS WERE CONSISTENT WITH THE OTHER RELEASE MEMBERS RETURNED. DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION: GIVEN THE WITNESS MARKS ON THE INTACT RELEASE ASSEMBLIES, IT IS CONCLUDED THAT THE RELEASE MEMBER WIRE FRACTURES WERE CAUSED BY THE INSTRUMENT GRASPING BELOW THE INTENDED LOCATION. THE FRACTURE OF THE RELEASE MEMBER CORE WIRE THEN ALLOWED THE INTERNAL JAW ASSEMBLY TO RELEASE OUT THE DISTAL END UPON RELEASE OF THE CLIP. IT IS FEASIBLE THAT FRACTURE OF CORE WIRE BALLED END WAS FRACTURED ON THE FOURTH SAMPLE, CAUSING THE COMPONENTS OF THE INTERNAL ASSEMBLY TO BECOME LOOSE FRAGMENTS UPON RELEASE OF THE CLIP. HOWEVER, IT WAS NOT POSSIBLE TO DRAW THIS CONCLUSION GIVEN THE COMPONENTS RETURNED FOR EVAL.

    Description of Event or Problem · 1

    MEDTRONIC CARDIOVASCULAR RECEIVED INFO THAT DURING A PROCEDURE, THREE OUT OF SIX UCLIP MECHANISMS FRACTURED AND PIECES HAD TO BE REMOVED FROM THE PT'S BODY. IT WAS REPORTED THAT THE SURGEON WAS A NEW USER AND GRABBED THE RELEASE MECHANISM IN THE INCORRECT AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U-CLIP SUTURE DEVICE FZP MEDTRONIC PERFUSION SYSTEMS B180 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening