BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1894969 · Received November 5, 2010

    Report

    Report Number
    2953144-2010-02738
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    October 16, 2010
    Report Date
    October 18, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 ACHIEVED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER PLACING AN UNSPECIFIED STENT IN THE ILIAC ARTERY. REPORTEDLY, ONE DAY POST PROCEDURE, THE PATIENT EXPERIENCED LEG PAIN AND AN ULTRASOUND WAS PERFORMED. THE COMMON FEMORAL ARTERY WAS FOUND OCCLUDED BELOW THE DEPLOYED CLIP. FOUR DAYS POST PROCEDURE, A BALLOON ANGIOPLASTY WAS PERFORMED TO SUCCESSFULLY OPEN THE ARTERY. PHYSICIAN DOES NOT BELIEVE THAT THE CLIP WAS ASSOCIATED WITH THE OCCLUSION. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention