BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2063236 · Received April 19, 2011

    Report

    Report Number
    2024168-2011-02738
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 ARE LIMITED TO, TISSUE COMPACTION THAT RESULTS IN A DISTAL FORCE BEING APPLIED TO THE LOCATOR WINGS, BENDING THEM DISTALLY, AND RESTRICTING THEIR PROPER RETRACTION INTO THE DELIVERY TUBESET. ULTIMATELY, 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 ARE TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY MANUFACTURING RELATED NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. IN ADDITION, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE INFORMATION RECEIVED WITH THIS INCIDENT AND WITHOUT THE PRODUCT TO EXAMINE, A DEFINITIVE CAUSE FOR THE REPORTED EXPERIENCE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PHYSICIANS TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ACHIEVED HEMOSTASIS OF THE COMMON FEMORAL ARTERY AFTER INTERVENTIONAL PROCEDURES. REPORTEDLY, AFTER CLIP DEPLOYMENT, THE DEVICE WAS SLIGHTLY DIFFICULT TO REMOVE FROM THE PATIENT ANATOMY. IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, THE ACCESS PORTS WERE USED TO SUCCESSFULLY FACILITATE DEVICE REMOVAL. THE CLIP OF THE STARCLOSE SE DEVICE SUCCESSFULLY ACHIEVED 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 010276H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention