BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 4863539 · Received June 23, 2015

    Report

    Report Number
    2024168-2015-03522
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    March 16, 2015
    Report Date
    June 3, 2015
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT WEIGHT - EXACT WEIGHT REPORTED WAS (B)(6). THE DEVICE WAS REPORTED TO BE NOT RETURNING. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (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. 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

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED INDICATING: IT WAS REPORTED THAT ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A STARCLOSE DEVICE WITH A 6F SHEATH AFTER A DIAGNOSTIC AND INTERVENTIONAL PROCEDURE. REPORTEDLY, THE STARCLOSE CLIP WAS DEPLOYED, BUT DID NOT ACHIEVE HEMOSTASIS. MANUAL ARTERIAL COMPRESSION AND A NON-ABBOTT DEVICE WERE USED TO ACHIEVE HEMOSTASIS. THE NAME OF THE PHYSICIAN WAS NOT PROVIDED; THEREFORE, IT IS NOT KNOWN IF THE PHYSICIAN IS TRAINED IN THE USE OF THE STARCLOSE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    USER FACILITY MEDWATCH NUMBER (B)(4). EVENT DESC: WHEN THE PHYSICIAN DEPLOYED THE CLOSURE DEVICE IT FAILED, MANUAL PRESSURE HELD BY TECH FOR 15 MINUTES. BLEEDING CONTINUED FROM CLOSURE SITE. APPLIED FEMSTOP DEVICE; HEMOSTASIS ACCOMPLISHED. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? LEFT HEART CATH. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING). DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405549 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 40924K1

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention SHEATH: 6F