BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1851470 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02125
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    March 16, 2009
    Report Date
    March 19, 2009
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. THREE UNUSED AND ONE TRAINING SAMPLE WITH THE SAME PART NUMBER/LOT NUMBER AS THE COMPLAINT DEVICE WERE RETURNED FOR EVAL. FUNCTIONAL TESTING WAS PERFORMED ON ALL OF THE UNUSED RETURNED DEVICES AND THE DEVICES PASSED WITHIN PRODUCT SPECIFICATIONS. THE DEVICE USED FOR TRAINING PURPOSES HAD ITS COMPONENTS IN THE PROPER POST CLIP DEPLOYED, ACCESS PORT ACTIVATED POSITIONS. NO MANUFACTURING OR ABNORMAL OBSERVATIONS WERE DETECTED. A ROOT CAUSE FOR THE REPORTED EXPERIENCE COULD NOT BE DETERMINED BASED ON THE INVESTIGATION FINDINGS FROM THE TESTED SAMPLES. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CATH LAB TECHNICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, AFTER CLIP DEPLOYMENT, THE DEVICE WAS DIFFICULT TO REMOVE FROM THE PT'S ARTERY. IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, AN ATTEMPT WAS MADE TO USE THE ACCESS PORTS TO FACILITATE DEVICE REMOVAL; HOWEVER, IT WAS UNSUCCESSFUL. A "NICK AND SPREAD" IN THE TISSUE TRACK WAS PERFORMED AND THE DEVICE WAS REMOVED. HEMOSTASIS WAS ACHIEVED WITH THE CLIP. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 72045-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention