BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 4853004 · Received June 18, 2015

    Report

    Report Number
    2024168-2015-03367
    Event Type
    Injury
    Date Received
    June 18, 2015
    Date of Event
    May 22, 2015
    Report Date
    May 26, 2015
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 STARCLOSE SE DEVICE WAS DEPLOYED IN A MILDLY CALCIFIED RIGHT COMMON FEMORAL ARTERY. PER THE INSTRUCTIONS FOR USE - DO NOT DEPLOY THE CLIP IN AREAS OF CALCIFIED PLAQUE. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    THE PATIENT AND DEVICE CODES WERE CODED BY THE MANUFACTURER. (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE REPORTED EXPERIENCE OF DIFFICULTY TO DEPLOY THE THUMB ADVANCER AND CLIP APPEARS TO BE RELATED TO USER TECHNIQUE. THE TREATMENT APPEARS TO BE RELATED TO PROCEDURAL CIRCUMSTANCE. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER INCIDENTS FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE MILDLY CALCIFIED AND MILDLY TORTUOUS RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A STARCLOSE SE DEVICE WITH 6F SHEATH AFTER AN INTERVENTIONAL ILIAC STENTING PROCEDURE. REPORTEDLY, THE DEVICE FAILED TO DEPLOY. HEMOSTASIS WAS ACHIEVED APPLYING MANUAL ARTERIAL COMPRESSION. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE STARCLOSE SE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE FILED INITIAL MEDWATCH REPORT, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE THUMB ADVANCER WAS DIFFICULT TO DEPLOY WHICH RESULTED IN FAILURE TO DEPLOY THE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397971 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 41027K1

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention