BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRO-FLEX SHEATH INTRODUCER WITH AMC THROMBOSHIELD

    MDR report key: 1082673 · Received July 21, 2008

    Report

    Report Number
    6000002-2008-08135
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    April 22, 2008
    Report Date
    May 21, 2008
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYB
    PMA / PMN Number
    K885179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND EVALUATED. CUSTOMER REPORT WAS NOT CONFIRMED, THE CONTAMINATION SHIELD WAS ABLE TO BE UNFOLDED. THE INTRODUCER AND CONTAMINATION SHIELD WERE RETURNED. THE CONTAMINATION SHIELD WAS DETACHED FROM THE PROXIMAL HUB. THE LOCKING NUT AND THE TWO BLACK O-RINGS, WHICH HOLD THE CONTAMINATION SHIELD WERE ALSO DETACHED. THE BLACK O-RINGS WERE RETURNED AND THE LOCKING NUT WAS NOT. THE CLEAR TUBE BETWEEN THE PROXIMAL AND DISTAL CONNECTORS WERE STILL ATTACHED TO BOTH CONNECTORS. THE CLEAR TUBE DISCONNECTED EASILY, WHICH IS NORMAL, FROM THE DISTAL CONNECTOR.

    Description of Event or Problem · 1

    REPORTEDLY, THE CONTAMINATION SHIELD COULD NOT BE OUTSTRETCHED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRO-FLEX SHEATH INTRODUCER WITH AMC THROMBOSHIELD PERCUTANEOUS SHEATH INTRODUCER SET DYB EDWARDS LIFESCIENCES, PR I301BF85H 58424080

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other