BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1851475 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02126
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    March 1, 2009
    Report Date
    March 2, 2009
    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 Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: EVAL OF THE RETURNED DEVICE FOUND THREE BENT AND BROKEN VESSEL LOCATOR WINGS WITH NO OTHER DAMAGE OR ANOMALY DETECTED ON THE DEVICE, EXTERNAL OR INTERNAL. IT WAS DETERMINED THAT ALL OF THE WING MATERIAL WAS RETURNED WITH THE DEVICE BENT/BROKEN. BROKEN WINGS ARE CONSISTENT WITH DIFFICULT TO REMOVE DEVICES WHEN TISSUE COMPACTION RESULTS IN A DISTAL FORCE APPLIED TO THE LOCATOR WINGS, BENDING THEM DISTALLY, AND RESTRICTING PROPER RETRACTION INTO THE DELIVERY TUBE SET. COUNTER-TRACTION AND FORCE IS THEN APPLIED TO ACHIEVE DEVICE REMOVAL. NO OTHER ANOMALIES WERE DETECTED. BASED ON THE INVESTIGATION FINDINGS, THE ROOT CAUSE FOR THE DIFFICULT TO REMOVE CONDITION AND DAMAGED WINGS IS RELATED TO THE OPERATIONAL CONTEXT IN WHICH THE DEVICE WAS USED. NO MFG OR QUALITY ISSUES WERE DETECTED. 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, ACHIEVED ARTERIOTOMY CLOSURE OF A FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, AFTER CLIP DEPLOYMENT, THE DEVICE WAS DIFFICULT TO REMOVE FROM THE PT'S ARTERY. THE DEVICE WAS REMOVED USING FORCE; HEMOSTASIS WAS ACHIEVED WITH THE CLIP. IT WAS ALSO NOTED THAT ONE OF THE VESSEL LOCATOR WINGS WAS FOUND TO BE BROKEN. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO ADD'L INFO 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 70085-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention