BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1974244 · Received January 31, 2011

    Report

    Report Number
    2024168-2011-00557
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    December 7, 2010
    Report Date
    January 7, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND IT WAS FULLY CLIP DEPLOYED. THE STARCLOSE SE DEVICE CLIP WAS NOT RETURNED. THERE WAS EVIDENCE OF CLIP TINE SCRAPE MARKS, INDICATING A CLIP HAD BEEN LOADED ON THE DEVICE AND WAS DEPLOYED. ALL EXTERNAL AND INTERNAL OBSERVATIONS OF THE DEVICE WERE CONSISTENT FOR A NORMAL, FULLY CLIP DEPLOYED DEVICE. THE LOCATOR WINGS WERE FULLY RETRACTED INTO THE DISTAL-END OF THE CLIP DELIVERY TUBESET WITHOUT ANY OBSERVED DAMAGE TO THE LOCATOR WINGS. THERE WERE NO OTHER OBSERVATIONS. A POSSIBLE CAUSE FOR THE REPORTED LACK OF HEMOSTASIS MIGHT HAVE BEEN THE LOSS OF VESSEL ACCESS DURING DEVICE DEPLOYMENT WITH CLIP DEPLOYMENT OCCURRING IN THE SUBCUTANEOUS TISSUE, BUT COULD NOT BE CONFIRMED. THERE WAS NO REPORTED ANATOMICAL ISSUE THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INVESTIGATION FINDINGS, A ROOT CAUSE FOR THE REPORTED LACK OF HEMOSTASIS IS UNDETERMINED. NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT 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 DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL, ILIAC STENTING PROCEDURE. REPORTEDLY, AFTER CLIP DEPLOYMENT, BLEEDING CONTINUED. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. 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 930336H

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention