BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE DEVICE

    MDR report key: 1851482 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02119
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    February 24, 2009
    Report Date
    February 24, 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 Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: EVAL OF THE RETURNED DEVICE FOUND IT WAS FULLY CLIP DEPLOYED AND THE ACCESS PORT HAD BEEN USED TO FACILITATE DEVICE REMOVAL. THE DISTAL END OF THE DEVICE PRESENTED BENT VESSEL LOCATOR WINGS, WHICH IS CONSISTENT WITH DIFFICULT DEVICE REMOVAL. THE WINGS WERE INTACT AND SECURE WITHIN THE VESSEL LOCATOR ASSEMBLY. A POSSIBLE CAUSE FOR THE BENT WINGS MAY HAVE BEEN DUE TO COMPACTION OF SUBCUTANEOUS TISSUE BETWEEN THE DEPLOYED LOCATOR WINGS AND THE DISTAL END OF THE DEVICE'S CLIP DELIVERY TUBE DURING DEPLOYMENT, BENDING THE WINGS DISTALLY. THIS CONDITION CAN RESULT IN THE INABILITY OF THE LOCATOR WINGS TO RETRACT INTO THE CLIP DELIVERY TUBE AFTER CLIP DEPLOYMENT, MAKING THE DEVICE REMOVAL DIFFICULT AND REQUIRING THE ACTIVATION OF THE ACCESS PORTS. BASED ON THE INVESTIGATION FINDINGS, THE ROOT CAUSE FOR THE 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 THE RIGHT COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, AFTER DEPLOYING THE CLIP, THE DEVICE WAS DIFFICULT TO REMOVE. IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, THE ACCESS PORTS WERE USED TO SUCCESSFULLY REMOVE THE DEVICE FROM THE PT'S ANATOMY. THE CLIP WAS DELIVERED AND ACHIEVED HEMOSTASIS APPROPRIATELY. NO ADVERSE PT EFFECTS WERE REPORTED. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE DEVICE MGB ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 71036-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention