BEUDAMED
    FDA Adverse Event Summary report: N

    STARCLOSE PROGLIDE

    MDR report key: 3823357 · Received May 5, 2014

    Report

    Report Number
    3823357
    Date Received
    May 5, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 5, 2014
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PER THE PROCEDURE LOG, FOLLOWING REMOVAL OF THE ARTERIAL SHEATH, THE ABBOTT STARCLOSE CLOSURE DEVICE WAS INSERTED AND DEPLOYED. DOCUMENTATION ENTERED TEN MINUTES AFTER DEPLOYMENT NOTES THAT THE STARCLOSE ATTEMPT HAD FAILED. A FEMOSTOP WAS APPLIED TO THE SITE. THE DEVICE WAS SECURED AT THAT POINT. CONTINUOUS ASSESSMENT OF THE PATIENT REVEALED NO SUBSEQUENT BLEEDING OR EVIDENCE OF A HEMATOMA.PER MATERIALS MANAGEMENT, THE DEVICE WAS RETURNED TO THE MANUFACTURER. HOWEVER, THE DATE IS NOT KNOWN BY THIS DEPARTMENT AT THIS TIME. ACCORDING TO THE PHYSICIAN, THE PRODUCT FAILED AND HE WANTS THE PRODUCT EVALUATED BY ABBOTT VASCULAR, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268573 STARCLOSE PROGLIDE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR * 31204K1

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR OTHER| NO. DEVICE WAS USED AT END OF CASE TO SEAL THE| RIGHT GROIN.