BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 1037041 · Received May 5, 2008

    Report

    Report Number
    2953144-2008-00846
    Event Type
    Injury
    Date Received
    May 5, 2008
    Date of Event
    February 1, 2008
    Report Date
    April 11, 2008
    Manufacturer
    ABBOTT VASCULAR REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT INVOLVES A STUDY NOTED IN AN ARTICLE. NO DEVICES SERE AVAILABLE FOR ANALYSIS. THE PART AND LOT NUMBER WERE NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. ATTACHMENT: ALJOSCHA RASTA, MD., ET AL. "A PROSPECTIVE, RANDOMIZED SINGLE-CENTER COMPARISON OF 2 DIFFERENT CLOSURE DEVICES WITH A HEMOSTATIC WOUND DRESSING FOR CLOSURE OF FEMORAL ARTERY ACCESS SITES". J ENDOVASC THER 2008; 15:83-90.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: UNKNOWN. TIME OF DEVICE MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. THE FOLLOWING EVENTS WERE NOTED THROUGH A PERIODIC ARTICLE REVIEW. A STUDY WAS CONDUCTED TO COMPARE THE SAFETY AND PERFORMANCE OF 2 CLOSURE DEVICES VERSUS A HEMOSTATIC WOUND DRESSING FOR FEMORAL ARTERY ACCESS SITE CLOSURES IN 852 PATIENTS WHO UNDERWENT DIAGNOSTIC AND INTERVENTIONAL CATHETERIZATION PROCEDURES. IT WAS REPORTED THAT 286 PATIENTS UNDERWENT ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY USING THE STARCLOSE DEVICE. REPORTEDLY, MAJOR COMPLICATIONS INCLUDED 1 ACCESS SITE BLEEDING REQUIRING SURGICAL CLOSURE AND 7 PSEUDOANEURYSMS THAT WERE TREATED SUCCESSFULLY WITH ULTRASOUND-GUIDED COMPRESSION THERAPY. ADDITIONALLY, MINOR COMPLICATIONS INCLUDED 34 ACCESS SITE BLEEDING REQUIRING ADJUNCTIVE THERAPY SUCH AS MANUAL COMPRESSION AND/OR PRESSURE BANDAGE AND 6 HEMATOMAS. THE HEMATOMAS WERE REPORTED TO MEASURE MORE THAN OR EQUAL TO 5 CM. NO INFO REGARDING A DEVICE MALFUNCTION WAS DESCRIBED. NO ADDITIONAL INFO WAS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R| S HEPARIN SHEATH: 277 CLIP PATIENTS = 6F| ORAL ANTICOAGULATION WAS GIVEN TO 20 OF THE CLIP| ASPIRIN WAS GIVEN TO 269 OF THE CLIP PATIENTS| CHOPIDOGREL WAS GIVEN TO 266 OF THE CLIP PATIENTS| 9 CLIP PATIENTS = 5F| PATIENTS