BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2882491 · Received December 20, 2012

    Report

    Report Number
    2024168-2012-08221
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 8, 2012
    Report Date
    December 10, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).EVALUATION SUMMARY:THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED EVENT WAS CONFIRMED. BASED ON VISUAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FROM THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. ESTIMATED DATE OF OCCURRENCE, DATE OF PROCEDURE OCCURRED WITHIN PAST TWO MONTHS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF AN UNSPECIFIED VESSEL WAS ATTEMPTED USING A STARCLOSE SE DEVICE AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, AN UNSPECIFIED DEVICE FAILURE OCCURRED. THE METHOD OF ACHIEVING HEMOSTASIS WAS NOT REPORTED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. AS THE NAME OF THE PHYSICIAN WAS NOT PROVIDED BY THE HOSPITAL, IT IS UNKNOWN IF THE PHYSICIAN IS TRAINED IN THE USE OF THE STARCLOSE SE DEVICE. 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 20817K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention