BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2061482 · Received April 18, 2011

    Report

    Report Number
    2024168-2011-02711
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 24, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION

    Additional Manufacturer Narrative · 1

    (B)(4): CORRECTED LOT NUMBER EVALUATION OF THE RETURNED DEVICE FOUND THAT THE THUMB ADVANCER WAS PARTIALLY RETRACTED FROM THE FINISH POSITION, AN INDICATION THAT THE ACCESS PORTS WERE USED. 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 TUBE SET. 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. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. IN ADDITION, A QUERY OF THE COMPLAINT DATABASE WAS PERFORMED AND THERE WERE NO SIMILAR COMPLAINTS WITHIN THIS LOT AT THE TIME THE INVESTIGATION WAS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TECHNICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, AFTER CLIP DEPLOYMENT, DIFFICULTY WAS ENCOUNTERED DURING DEVICE REMOVAL. IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, A DILATOR WAS INSERTED INTO THE ACCESS PORTS UNLOCKING THE THUMB ADVANCER AND CLIP DELIVERY TUBESET ENABLING THEM TO BE RETRACTED PROXIMALLY AND COUNTER-TRACTION WITH AN ASSERTIVE PULL WERE APPLIED, WHICH RELEASED THE DEVICE FROM THE TISSUE TRACT. WHEN THE DEVICE WAS REMOVED, THE CLIP WAS NOTED DEPLOYED IN THE INTENDED LOCATION AND HEMOSTASIS WAS ACHIEVED. 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 960116H

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention