BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2013602 · Received March 10, 2011

    Report

    Report Number
    2024168-2011-01554
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND THAT THE DISTAL END OF THE DEVICE APPEARED NORMAL AND THE EXCHANGE SHEATH WAS FULLY SLIT. THE THUMB ADVANCER WAS STILL AT THE FINISH POSITION WITH THE DETENT FEET STILL IN PLACE. DURING CLIP DEPLOYMENT THE VESSEL LOCATOR WINGS ARE DESIGNED TO AUTOMATICALLY COLLAPSE SO AS NOT TO INTERFERE WITH THE CLIP DEPLOYMENT; HOWEVER, DURING THE INSPECTION OF THE DEVICE, THE VESSEL LOCATOR WINGS WERE FOUND BENT. THE BENT LOCATOR WINGS INDICATE THAT DISTAL FORCES WERE APPLIED TO THE WINGS DURING THUMB ADVANCEMENT PREVENTING THEM FROM COLLAPSING PROXIMALLY INTO THE TUBESET. TISSUE COMPRESSED BETWEEN THE DISTAL END OF THE TUBES AND BEHIND THE OPEN VESSEL LOCATOR WINGS DURING THUMB ADVANCEMENT IS THE MOST PROBABLE CAUSE FOR THE BENT LOCATOR WINGS AND SUBSEQUENTLY CONTRIBUTED TO DIFFICULT DEVICE REMOVAL. NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    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. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, THE CLIP WAS DEPLOYED HOWEVER, THE DEVICE WAS DIFFICULT TO REMOVE. THE ACCESS PORTS WERE USED UNSUCCESSFULLY. THE THUMB ADVANCER WAS SLID DOWN FURTHER AND SPLIT THE SHEATH A LITTLE FURTHER, WHICH ALLOWED THE DEVICE TO BE REMOVED FROM THE PATIENT ANATOMY. HEMOSTASIS WAS ACHIEVED WITH THE CLIP. THERE WERE NO REPORTED ADVERSE PATIENT SEQUALE. 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 930046H

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention