BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1851691 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02284
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    August 6, 2009
    Report Date
    August 6, 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
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: EVAL OF THE RETURNED DEVICE REVEALED THAT THE LOCATOR WINGS WERE BENT DURING THUMB ADVANCER DEPLOYMENT, PREVENTING THE WINGS FROM FULLY COLLAPSING INTO THE DELIVERY TUBESET WHEN THE CLIP WAS FIRED. THE FAILURE OF THE WINGS TO COMPLETELY COLLAPSE INTO THE DELIVERY TUBESET DIRECTLY RESULTED IN DIFFICULT DEVICE REMOVAL. THE DEVICE WAS SUCCESSFULLY REMOVED VIA UTILIZING THE ACCESS PORTS. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE ROOT CAUSE FOR THE BENT LOCATOR WINGS THAT DIRECTLY RESULTED IN THE REPORTED DIFFICULT DEVICE REMOVAL IS TISSUE COMPACTION THAT EXERTED A DISTAL FORCE ON THE WINGS WHILE IN THE TISSUE TRACT. TISSUE TRAPPED BETWEEN THE DISTAL END OF THE TUBESET AND THE LOCATOR WINGS CAN BEND THE WINGS AND INTERFERE WITH DEVICE REMOVAL. 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 COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, THE DEVICE WAS DIFFICULT TO REMOVE. IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, THE ACCESS PORTS WERE USED TO REMOVE THE DEVICE FROM THE PATIENT'S ANATOMY. HEMOSTASIS WAS ACHIEVED WITH THE CLIP OF THE DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THOUGH REQUESTED, NO ADD'L INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 78023-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention