BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2072355 · Received April 28, 2011

    Report

    Report Number
    2024168-2011-02990
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 6, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. A DEVICE CAN BE DIFFICULT TO REMOVE DUE TO A NUMBER OF FACTORS INCLUDING, BUT NOT LIMITED TO, TISSUE COMPACTION RESULTING IN A DISTAL FORCE BEING APPLIED TO THE LOCATOR WINGS, BENDING THEM DISTALLY, AND RESTRICTING THEIR PROPER RETRACTION INTO THE DELIVERY TUBE SET. THE RETURN OF THE DEVICE MAY HAVE AIDED THE INVESTIGATION IN DETERMINING A CAUSE FOR THE EXPERIENCED EVENT. TO ENSURE THIS TYPE OF EXPERIENCE IS NOT A RESULT OF A POTENTIAL PRODUCT RELATED DEFICIENCY, A SAMPLING OF FINISHED DEVICES IS ALSO TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE. THE LOT HISTORY RECORD FOR THIS PRODUCT COULD NOT BE REVIEWED AND A QUERY OF THE COMPLAINT-HANDLING DATABASE COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT REPORTED AND THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED WITH THIS INCIDENT AND WITHOUT THE PRODUCT TO EXAMINE, A DEFINITIVE CAUSE FOR THE REPORTED EXPERIENCE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN USING THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, FOLLOWING CLIP DEPLOYMENT, RESISTANCE WAS MET WHEN REMOVING THE DEVICE AND HEMOSTASIS WAS NOT ACHIEVED. MANUAL COMPRESSION AND A NON-ABBOTT DEVICE WERE APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention