BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 1171304 · Received September 22, 2008

    Report

    Report Number
    2953144-2008-01518
    Event Type
    Injury
    Date Received
    September 22, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 28, 2008
    Manufacturer
    ABBOTT VASCULAR - REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. DEVICE CODE 1670: (AGAINST RESISTANCE): THE STARCLOSE INSTRUCTIONS FOR USE (IFU) STATE, "NOTE: DO NOT ADVANCE THE THUMB ADVANCER AGAINST EXCESSIVE RESISTANCE." "EXCESSIVE FORCE USED TO ADVANCE OR TORQUE THE STARCLOSE DEVICE SHOULD BE AVOIDED, AS THIS MAY LEAD TO SIGNIFICANT VESSEL DAMAGE AND/OR BREAKAGE OF THE DEVICE, WHICH MAY NECESSITATE INTERVENTION AND/OR SURGICAL REMOVAL OF THE DEVICE AND VESSEL REPAIR."

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: THUMB ADVANCER RESISTANCE, DETACHED EXCHANGE SHEATH. TIME OF REPORTED EVENT: DURING VESSEL CLOSURE. SYMPTOMS/AE: EXCHANGE SHEATH REMOVAL, FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A TECHNICIAN IN-TRAINING IN THE USE OF THE STARCLOSE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, DURING SHEATH SPLITTING, STRONG RESISTANCE WAS FELT WHILE ADVANCING THE THUMB ADVANCER AND A PORTION OF THE EXCHANGE SHEATH DETACHED IN THE VESSEL. THE DETACHED PIECE WAS SNARED USING HEMOSTATS. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR - REDWOOD CITY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention