BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2761020 · Received September 26, 2012

    Report

    Report Number
    2024168-2012-06078
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    September 3, 2012
    Report Date
    September 12, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. PATIENT REPORTED TO BE (B)(6). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. REVIEWS OF THE LOT HISTORY RECORD AND COMPLAINT HANDLING DATABASE COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY (CFA) WAS ACHIEVED UNEVENTFULLY AFTER A DIAGNOSTIC HEART CATHETERIZATION PROCEDURE. REPORTEDLY, APPROXIMATELY 2 HOURS POST PROCEDURE, THE PATIENT HAD A COLD LEG. THROMBUS WAS DETECTED IN THE CFA. AN EMERGENT THROMBECTOMY WAS PERFORMED AND IT WAS OBSERVED THAT THE CLIP WAS EXTRA VASCULAR; IT WAS DEPLOYED PROPERLY, AT THE CORRECT LOCATION, ON TOP OF THE CFA; HOWEVER IT WAS REMOVED FROM THE PATIENT DURING THE THROMBECTOMY. THE PHYSICIAN BELIEVES THE CLIP MAY HAVE CAUSED OR CONTRIBUTED TO THE THROMBOSIS, SINCE THE THROMBOSIS WAS NOT PRE-EXISTING AND APPEARED 2 HOURS POST-PROCEDURE. THE EVENT RESULTED IN ONE DAY OF ADDITIONAL PATIENT HOSPITALIZATION. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE NURSE WHO DEPLOYED THE CLIP IS REPORTED TO BE TRAINED IN THE USE OF THE STARCLOSE SE DEVICE. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R SHEATH: 6 FR.