BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1903775 · Received November 20, 2010

    Report

    Report Number
    2953144-2010-02926
    Event Type
    Injury
    Date Received
    November 20, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 27, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. (B)(4)-FAILURE TO FOLLOW INSTRUCTIONS/STEPS REPRESENTS THAT A NICK-AND-SPREAD WAS NOT PERFORMED ADEQUATELY AT THE BEGINNING OF THE PROCEDURE. THE INSTRUCTIONS FOR USE STATES:IT IS NECESSARY TO CREATE A 5-7 MM SKIN INCISION AT THE SHEATH SITE TO ACCOMMODATE THE INSERTION OF THE CLIP DELIVERY TUBE INTO THE TISSUE TRACT. THIS SHOULD BE DONE AT THE BEGINNING OF THE PROCEDURE PRIOR TO THE ADMINISTRATION OF ANTICOAGULANTS AND ANTIPLATELET AGENTS, IF POSSIBLE. CONSIDER BLUNT DISSECTION BY SINGLE SPREAD WITH SURGICAL INSTRUMENT IN THE SKIN INCISION, ESPECIALLY IN THOSE PATIENTS WITH SCAR TISSUE FROM PREVIOUS CATHETERIZATION PROCEDURES. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, "WHILE INTRODUCING THE DEVICE HE (THE PHYSICIAN) TOOK DOWN A LITTLE SKIN TO THE VESSEL AND CLIPPED IT ON THE VESSEL." DIFFICULTY WAS ENCOUNTERED DURING DEVICE REMOVAL. THE DEVICE WAS REMOVED WITH A SURGICAL KNIFE. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. IT WAS BELIEVED THE PHYSICIAN DID NOT PERFORM AN ADEQUATE NICK-AND-SPREAD PRIOR TO DEVICE INSERTION. THOUGH REQUESTED, 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-REDWOOD CITY

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention