BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1984321 · Received February 10, 2011

    Report

    Report Number
    2024168-2011-00808
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    December 28, 2010
    Report Date
    January 19, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE ATTEMPTED ARTERIOTOMY CLOSURE OF AN UNSPECIFIED ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, DURING CLOSING, THE DEVICE "PULLED OUT". MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, IT WAS REPORTED THAT THE ACCESS SITE WAS THE RIGHT COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE AND THAT DURING THUMB ADVANCEMENT, THE DEVICE PULLED OUT. THE PHYSICIAN FELT HE MAY NOT HAVE MADE AN ADEQUATE NICK AND SPREAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 930426H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention