BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2800276 · Received October 22, 2012

    Report

    Report Number
    2024168-2012-06647
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    September 26, 2012
    Report Date
    October 3, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    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. ESTIMATED DATE OF OCCURRENCE, EXACT DATE WAS NOT RECALLED. (B)(4) PHYSICIAN NOT TRAINED IN USE OF THE STARCLOSE SE DEVICE. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REPORTEDLY, THE PHYSICIAN IS NOT TRAINED IN USE OF THE STARCLOSE SE DEVICE. THE INSTRUCTIONS FOR USE STATES: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN (OR ALLIED HEALTHCARE PROFESSIONALS, AUTHORIZED BY, OR UNDER THE DIRECTION OF, SUCH PHYSICIANS) WHO IS TRAINED IN DIAGNOSTIC AND THERAPEUTIC CATHETERIZATION PROCEDURES AND WHO HAS BEEN TRAINED BY AN AUTHORIZED REPRESENTATIVE OF ABBOTT VASCULAR. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED USING A STARCLOSE SE WITH A 6FR SHEATH, AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, THE DEVICE WAS DIFFICULT TO REMOVE AND COUNTER PRESSURE WAS USED TO REMOVE THE DEVICE. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. A CLINICALLY SIGNIFICANT DELAY OF A FEW HOURS WAS REPORTED FOR GROIN MANAGEMENT. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. 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 930336H

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention SHEATH: 6F