BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2883870 · Received December 21, 2012

    Report

    Report Number
    2024168-2012-08268
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    December 7, 2012
    Report Date
    December 14, 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). EVALUATION SUMMARY:THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED EVENT WAS CONFIRMED. BASED ON VISUAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED 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 DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING THE STARCLOSE SE DEVICE WITH A 6F SHEATH AFTER STENTING OF THE CIRCUMFLEX CORONARY ARTERY. REPORTEDLY, AFTER DEPLOYMENT OF THE STARCLOSE SE CLIP THE DEVICE WAS REMOVED; THE CLIP WAS FOUND TO BE CAPTURED IN THE DISTAL END OF THE SHEATH. HEMOSTASIS WAS ACHIEVED WITH 20-30 MINUTES OF MANUAL ARTERIAL COMPRESSION AND A FEMSTOP DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. 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
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 20810K1

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention SHEATH: 6F