BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYDER DEPLOYMENT TOOL

    MDR report key: 688796 · Received March 7, 2006

    Report

    Report Number
    2135394-2006-00004
    Event Type
    Malfunction
    Date Received
    March 7, 2006
    Date of Event
    February 7, 2006
    Report Date
    February 7, 2006
    Manufacturer
    MEDTRONIC CST
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DEVICE HAD ALREADY BEEN FIRED PRIOR TO USE; NO U-CLIPS DEPLOYED DURING THE CASE. THE SURGEON PREPARED THE VEIN FOR THE SPYDER DEVICE, BUT NO CLIPS RELEASED FROM THE UNIT DURING THE PROCEDURE AND THE DEVICE COULD NOT BE USED. THE AORTOTOMY WAS THEN REPAIRED WITH CONVENTIONAL SUTURE AND THE CASE COMPLETED WITH NO PATIENT COMPLICATION REPORTED, OTHER THAN BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPYDER DEPLOYMENT TOOL DEPLOYMENT TOOL FZP MEDTRONIC CST SPY 0529704

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention