BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1013852 · Received March 14, 2008

    Report

    Report Number
    2953144-2008-00146
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 21, 2008
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    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. THE PERCLOSE A-T INSTRUCTIONS FOR USE (IFU) (PRECAUTIONS) STATES "EXCESSIVE FORCE USED TO ADVANCE OR TORQUE THE PERCLOSE A-T SMC 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: DETACHED DISTAL GUIDE. SYMPTOMS/AE: VESSEL OCCLUSION. TIME OF DEVICE MALFUNCTION AND SYMPTOMS/AE: DURING AND AFTER VESSEL CLOSURE. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE A-T DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE DEVICE WAS DIFFICULT TO REMOVE FROM THE ARTERY. THE DEVICE WAS TWISTED SEVERAL TIMES DISTAL GUIDE DETACHMENT AND VESSEL OCCLUSION. THE DETACHED DISTAL GUIDE WAS SURGICALLY REMOVED AND THE ARTERY WAS SURGICALLY REPAIRED. THE PT WAS DISCHARGED TO HOME THE NEXT DAY AS PLANNED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM MGB ABBOTT VASCULAR-VASCULAR SOLUTIONS REDWOOD CITY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention OTHER: HEPARIN