BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2032854 · Received March 29, 2011

    Report

    Report Number
    2024168-2011-02117
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. EVALUATION FOUND THAT IT WAS NOT POSSIBLE TO PERFORM A THOROUGH ANALYSIS ON THE PRODUCT BECAUSE THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A PRODUCT QUALITY PROBLEM. THE PHYSICIAN DECIDED TO PERFORM AN ANGIOGRAM AFTER ATTACHING THE DEVICE TO THE EXCHANGE SHEATH. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. BASED ON THE INFORMATION RECEIVED WITH THIS COMPLAINT, THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF AN ISSUE WITH THE QUALITY OF THE PRODUCT.

    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 COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER THE STARCLOSE SE DEVICE WAS ATTACHED TO THE EXCHANGE SHEATH, THE PHYSICIAN WANTED TO TAKE AN ANGIOGRAM. THE SHEATH WAS CUT AROUND THE HUB AND THE STARCLOSE SE DEVICE WAS REMOVED. THE SHEATH REMAINED IN THE VESSEL AND A SECOND STARCLOSE SE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 950306H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention