BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1933078 · Received December 20, 2010

    Report

    Report Number
    2953144-2010-03293
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    December 15, 2010
    Report Date
    December 15, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION.THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED;THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER DEVICE DEPLOYMENT, HEMOSTASIS WAS ACHIEVED. UPON DISCHARGE, THE PATIENT EXPERIENCED PAIN IN THE RIGHT HIP. FEMORAL ANGIOGRAM REVEALED AN OCCLUSION AND THROMBOSIS IN THE RIGHT COMMON FEMORAL ARTERY AND THE DISTAL END OF THE ILIAC. TWO NON- ABBOTT DEVICES WERE USED TO REMOVE THE THROMBUS AND ACHIEVE ARTERIAL PATENCY. THE PHYSICIAN FELT THAT THE STARCLOSE SE DEVICE DID NOT CAUSE THE OCCLUSION OR THROMBOSIS AND THAT IT WAS CAUSED BY A FLAP OF TISSUE CREATED WHEN THE INITIAL ACCESS SHEATH WAS INTRODUCED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention