BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 3202144 · Received July 2, 2013

    Report

    Report Number
    2024168-2013-04142
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE WAS DISCARDED AND IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES RELATED TO THE REPORTED EVENT. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT-HANDLING DATABASE FROM THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. 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 AFTER A CAROTID STENTING PROCEDURE, ARTERIOTOMY CLOSURE OF THE LEFT COMMON FEMORAL ARTERY WAS ACHIEVED USING A STARCLOSE SE DEVICE. REPORTEDLY, AFTER CLIP DEPLOYMENT, HEMOSTASIS WAS ACHIEVED. HOWEVER, THE PATIENT DEVELOPED WEAKENING OF THE DISTAL PULSES OF THE LEFT LEG. USING ANGIOGRAPHY ONE OF THE CLIP TINES WAS OBSERVED TO BE DEPLOYED ON THE SIDEWALL OF THE VESSEL CAUSING PARTIAL OCCLUSION OF THE VESSEL. VIA THE RIGHT COMMON FEMORAL ARTERY, A DILATATION CATHETER WAS USED TO RELEASE THE CLIP TINE FROM THE SIDEWALL OF THE VESSEL RESTORING NORMAL DISTAL PULSES OF THE LEFT LEG. A SIGNIFICANT CLINICAL DELAY WAS REPORTED OF THE PROCEDURE. THE PHYSICIAN WAS 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
    303033 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 30419K1

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention SHEATH: 6-FRENCH HEPARIN