BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1894973 · Received November 5, 2010

    Report

    Report Number
    2953144-2010-02722
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 15, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVAL. IT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND IT WAS FULLY CLIP-DEPLOYED WITH ALL COMPONENTS IN THEIR PROPER POST CLIP DEPLOYMENT POSITIONS. THE LOCATOR WINGS WERE FULLY COLLAPSED AND THE EXCHANGE SHEATH WAS FULLY SLIT. THERE WERE NO ABNORMAL OBSERVATIONS TO SUGGEST THAT THE CLIP MIGHT HAVE BEEN CAPTURED AT THE DISTAL-END OF THE DEVICE; THEREFORE, THE REPORTED PRODUCT EXPERIENCE COULD NOT BE CONFIRMED. BASED ON THE INVESTIGATION FINDINGS, THE DEVICE PERFORMED ACCORDING TO SPECIFICATION. A ROOT CAUSE RELATED TO THE DEVICE COULD NOT BE DETERMINED. NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    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, AFTER CLIP DEPLOYMENT, BLEEDING CONTINUED. WHEN THE DEVICE WAS REMOVED, THE CLIP WAS FOUND TO BE DEPLOYED IN THE LOCATOR WINGS. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO ADD'L INFO WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THESE PRODUCTS DID NOT PASS THE INSPECTION FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 920316H

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention