BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2033036 · Received March 29, 2011

    Report

    Report Number
    2024168-2011-02139
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND THE DISTAL END WAS NORMAL AND THE EXCHANGE SHEATH WAS FULLY SLIT. THE LOCATOR WINGS WERE IN THE DEPLOYED POSITION AND THERE WAS NO EVIDENCE OF TISSUE BEING CAUGHT ON THE WINGS, AS REPORTED. THE DEVICE WAS RETURNED FULLY CLIP-DEPLOYED WITH ALL EXTERNAL AND INTERNAL COMPONENTS IN APPROPRIATE POST CLIP DEPLOYMENT POSITION. CLIP TINES MARKS WERE OBSERVED ON THE CARRIER TUBE, INDICATING THAT A CLIP WAS ORIGINALLY LOADED ON THE CARRIER TUBE AND FIRED DURING USE. DURING THE INVESTIGATION, THE DEVICE WAS CLEANED AND REASSEMBLED FOR REDEPLOYMENT TESTING. THE LOCATOR WINGS DEPLOYED PROPERLY AND STAYED OPEN. BASED ON THE EVALUATION OF THE RETURNED DEVICE THE REPORTED EXPERIENCE COULD NOT BE CONFIRMED. A REVIEW OF THE FINISHED DEVICE HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT.

    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, ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER COMPLETING STEP 3 (THUMB ADVANCEMENT) THE DEVICE CAME OUT OF THE ARTERY. MANUAL COMPRESSION AND A NON-ABBOTT DEVICE WERE USED TO ACHIEVE HEMOSTASIS. DURING DEVICE INSPECTION IT WAS NOTICED THAT SOME TISSUE HAD BEEN CAUGHT IN THE LOCATOR WINGS; THESE WERE FOLDED UP. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECT. 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 950026H

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention HEPARIN.